SFDA National Center for Medical Devices Reporting

Medical Devices Sector قطاع الأجهزة الطبية	NCMDR National Center for Medical Devices Reporting المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
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Reference Number	Manufacturer	Device Type	Report Source
mdprc 101 11 18 001	Medtronic	Suction/Anticoagulation Assembly Lines	BfArM
mdprc 002 12 18 002	Medtronic	Medtronic HeartWare HVAD System Battery Charger	https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=169057
mdprc 028 12 18 000	Cis Bio International	Cisbio - Chromogranin A (CGA-ELISA)	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01522-1
mdprc 027 12 18 000	Shimadzu Medical Systems.	Digital Angiography System Trinias	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01487-1
mdprc 026 12 18 000	Synovis Micro Companies Alliance Inc.	Synovis GEM4183C Coupler Forceps	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01519-1
mdprc 018 12 18 000	Hologic Inc.	I-View Contrast Enhanced Digital Mammography	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01515-1
mdprc 017 12 18 000	MED-EL Elektro-Medizinische Geraete GmbH	Sonata ti100	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01511-1
mdprc 016 12 18 000	SIEMENS	Syngo.plaza version VB30A_HF01 and previous software versions	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01509-1
mdprc 015 12 18 000	Stryker Neurovascular	Balloon Guide Catheters 9F	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01500-1
mdprc 014 12 18 000	Intuitive Surgical Inc.	da Vinci Xi Surgical System Arm Sensor	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01501-1
mdprc 003 12 18 000	Optics Medical	Raindrop Near Vision Inlays	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01465-1
mdprc 001 12 18 000	Medicina	Medicina CG Nasogastric Tubes	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01482-1
mdprc 102 11 18 000	RaySearch Laboratories	RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6, RayStation 7, and RayStation 8A	http://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-01468-1
mdprc 073 11 18 000	Eurotrol B.V	HemoTrol Hemoglobin Controls	https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01436-1
mdprc 072 11 18 000	GE Healthcare	Revolution CT Systems with SmartStep Option	https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01452-1
mdprc 071 11 18 000	House With No Steps	FG107 Intravitreal Procedure Pack #1 and FG110 Intravitreal Procedure Pack #2A	https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01442-1
mdprc 070 11 18 000	Misonix, Inc.	BoneScalpel and SonaStar FS1000 Ultrasonic Surgical Systems	https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01444-1
mdprc 055 11 18 000	Diagnostica Stago	STACLOT LA (REF. 00600).	NCMDR
mdprc 038 11 18 000	Carestream Health	Kodak DirectView DR 7500 System	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01434-1
mdprc 037 11 18 000	Cambridge Nutritional Sciences Ltd	FoodPrint Microarray 200+ Food IgG.	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01431-1
mdprc 036 11 18 000	BioArray Solutions Ltd.	HEA Precise Type Beadchip Kit and RHD Beadchip Kit, CE.	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01435-1
mdprc 017 11 18 000	Argon Medical Devices	4-Way Stopcock w/MLL, Adapter DBL Male and Female LL	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01423-1
mdprc 005 11 18 000	Carl Zeiss	Plex Elite 9000	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01414-1
mdprc 152 10 18 000	BioArray Solutions Ltd.	RHD BeadChip Kit	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01399-1
mdprc 132 10 18 000	IRIS Diagnostics	iChemVELOCITY Urine Chemistry strips	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01395-1
mdprc 131 10 18 000	bioMerieux Inc.	NUCLISENS Lysis Buffer. An in vitro diagnostic medical device (IVD).	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01392-1
mdprc 130 10 18 000	GE Healthcare	CARESCAPE R860 Inspiratory Safety Guard	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01398-1
mdprc 117 10 18 000	Demeditec Diagnostics GmbH	Reverse T3 RIA	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01390-1
mdprc 116 10 18 000	Siemens Healthcare	Biograph mMR with software version syngo E11P when using BodyCOMPASS	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01388-1
mdprc 112 10 18 000	ICU Medical, Inc.	Lifeshield Primary Plum Set 15 Micron Filter in Sight Chamber, CLAVE Secondary Port, 0.2 Micron Filter, CLAVE Y-Site, Polyethylene Lined Tubing, Secure Lock 272 cm / 23 mL	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01375-1
mdprc 111 10 18 000	Paragon 28, Inc.	TITAN 3-D Wedge, Evans, Large, 10mm	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01380-1
mdprc 088 10 18 000	LeMaitre Vascular	Pruitt F3-S Polyurethane Outlying Carotid Shunt	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01352-1
mdprc 087 10 18 000	Enterix Pty Ltd	ColoVantage Home-Faecal Immunochemical Test Kits.	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01128-1
mdprc 063 08 18 001	Orthosensor Inc.	VERASENSE ZBH-PSNCREF311-R CR E-F/3-11 Right.	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01135-1
mdprc 049 10 18 000	Baxter Healthcare	EXACTAMIX Empty EVA Bags	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01333-1
mdprc 048 10 18 000	Belmont Instrument Corp	Buddy Disposable Sets	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01327-1
mdprc 047 10 18 000	Datascope Corp	CARDIOSAVE Intra-Aortic Balloon Pumps	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01317-1
mdprc 046 10 18 000	GE Healthcare	LOGIQ E10 ultrasound systems (when used with TEE probes)	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01304-1
mdprc 045 10 18 000	Integra LifeSciences	CUSA Excel (Excel+) Ultrasonic Surgical Aspirator System	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01324-1
mdprc 044 10 18 000	K2M Inc.	YUKON OCT Spinal System Polyaxial Screw Size 3.5 x 34mm	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01326-1
mdprc 043 10 18 000	RaySearch Laboratories	RayStation and RayPlan	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01322-1
mdprc 042 10 18 000	Siemens Healthcare Diagnostics	Dimension Integrated Chemistry Systems	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01328-1
mdprc 041 10 18 000	Siemens Healthcare Diagnostics	RAPIDPoint 500 Blood Gas Systems	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01330-1
mdprc 040 10 18 000	SIEMENS	Biograph mCT and Biograph Horizon Systems	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01329-1
mdprc 018 05 17 001	Abbott Medical Optics Inc.	Vitrectomy Cutter	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01301-1
mdprc 031 10 18 000	Medtronic	O-arm O2 Imaging Systems	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01313-1
mdprc 030 10 18 000	TiSport	X-Short anti-tip tubes on certain TiLite manual wheelchairs	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01302-1
mdprc 109 08 18 001	Bio Rad	Pastorex Meningitis - reagent R4 (Streptococcus pneumoniae latex - green cap bottle).	Swissmedic Update
mdprc 088 09 18 000	Abbott Laboratories	ARCHITECT ICT Modules	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01256-1
mdprc 087 09 18 000	Baxter Healthcare	AK 98 Hemodialysis Devices	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01233-1
mdprc 086 09 18 000	Leica	BOND Slide Labeller Zebra Printer Power Supply Unit (PSU) for use with BOND-lll and BOND-MAX instruments.	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01254-1
mdprc 085 09 18 000	Samsung Electronics	Samsung Digital X-Ray System	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00982-1
mdprc 084 09 18 000	Siemens Healthcare Diagnostics	ADVIA Chemistry Creatine Kinase (CK_L) System Reagent	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01271-1
mdprc 081 09 18 000	Alcon Laboratories Inc.	CyPass Micro-Stents	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01228-1
mdprc 080 09 18 000	Bio Rad.	VIROTROL HIV-1 Ag	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01255-1
mdprc 079 09 18 000	Bio-Rad Laboratories	D-100 Haemoglobin Testing System	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01239-1
mdprc 104 08 18 001	Siemens Healthcare Diagnostics	Aptio Automation and StreamLAB Automation.	http://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-01181-1
mdprc 110 08 18 000	AGFA Corp.	DX-D 600 Digital Radiography Systems	http://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-01140-1
mdprc 108 08 18 000	Cepheid	Xpert Xpress Flu/RSV assay	http://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-01155-1
mdprc 107 08 18 000	CERNER	Cerner Dosage Calculator used via PowerOrders or Pharmacy Medication Manager	http://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-01060-1
mdprc 106 08 18 000	Evolutis	Broach Handles for rasp used in orthopaedic surgery	http://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-01127-1
mdprc 105 08 18 000	Permobil	M300 PS, C300 PS, C350 PS, C500 PS, (PS Seating only)	http://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-01143-1
mdprc 103 08 18 000	Smiths Medical	Jelco ViaValve safety I.V. catheter	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01206-1
mdprc 102 08 18 000	Stryker	Hoffmann Limb Reconstruction Frame (LRF) System Hexapod Struts	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01203-1
mdprc 101 08 18 000	Therakos Inc.	Therakos Cellex Photopheresis System	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01156-1
mdprc 100 08 18 000	TransMedics	Organ Care System (OCS) Heart system - OCS Heart Console	http://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-01113-1
mdprc 099 08 18 000	Vision RT	AlignRT Plus/OSMS system	http://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-01166-1
mdprc 096 08 18 000	Medtronic	Tools Database v1.288 CD	http://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-01137-1
mdprc 095 08 18 000	Olympus	Olympus Bronchofiberscopes, Bronchovideoscopes, Bronchofibervideoscopes, Ultrasonic Bronchofibervideoscopes, Rhino-laryngo Videoscopes and Airway Mobilescopes	http://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-01145-1
mdprc 064 08 18 000	SPATZ FGIA, INC..	Spatz3 Adjustable Gastric Balloon System	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01039-1
mdprc 062 08 18 000	Medtronic SA	Capnostream 20 and Capnostream 20p Bedside Patient Monitors	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01102-1
mdprc 061 08 18 000	Medical Components, Inc	Short Term Haemodialysis Catheters	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01084-1
mdprc 060 08 18 000	MAKO Surgical Corp	Mako Vizadiscs and Vizadisc Hip Tracking Kit	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01129-1
mdprc 059 08 18 000	Air Liquide Medical Systems	Matrx Digital MDM Mixer	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01099-1
mdprc 058 08 18 000	Stryker Europe	Hoffmann LRF Hexapod Software.	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01118-1
mdprc 057 08 18 000	Sage In-Vitro Fertilization Inc	Various in vitro fertilisation (IVF) and assisted reproduction technologies (ART) products	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00594-1
mdprc 056 08 18 000	Beckman Coulter Inc..	UniCel DxH 800 and UniCel DxH 600 Coulter Cellular Analysis System	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01103-1
mdprc 041 08 18 000	Medos Medizintechnik AG.	Deltastream Heater-Cooler Unit	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00886-1
mdprc 040 08 18 000	Elekta Inc	MOSAIQ Medical Oncology version 2.64 SP3 and higher	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01070-1
mdprc 039 08 18 000	Draeger Medical Systems Inc	Dräger Ceiling Supply Unit; AGILA and Movita Lift Pendants	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01066-1
mdprc 038 08 18 000	Medtronic SA	BIS Vista and BIS View Monitoring Systems	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01053-1
mdprc 037 08 18 000	Thermo Fisher Scientific Inc.	PP2030 Mannitol Salt Agar Plates.	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01028-1
mdprc 036 08 18 000	Esaote S.p.A.	MyLab Alpha in combination with IH 6-18	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01043-1
mdprc 011 03 18 001	Natus Neurology	Natus NicoletOne 32Ch Ambulatory EEG Record System	https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=164231
mdprc 116 07 18 000	Bio-Rad Laboratories Inc	IH-Com Fullversion & IH-Com for Reader	http://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-01010-1
mdprc 115 07 18 000	Bio-Rad Laboratories Inc	CFX96-IVD Optical Reaction Module	http://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-01004-1
mdprc 102 07 18 000	Integra LifeSciences	MAYFIELD Spine Table Adapters and Various Infinity XR2 Base Units	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00912-1
mdprc 025 07 18 001	B Braun Surgical SA	Safil Sutures	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00737-1
mdprc 070 07 18 000	LivaNova	Platinium Implantable Cardiac Defibrillator (ICD) and Resynchronisation Therapy Defibrillator (CRT-D)	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00929-1
mdprc 067 07 18 000	Getinge Lancer	GETINGE EDS8 (Endoscope Drying and Storage Cabinet) Compressor	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00906-1
mdprc 054 07 18 000	Elekta Inc.	Leksell GammaPlan 11.1	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00844-1
mdprc 053 07 18 000	Medtronic	Guardian Connect Mobile App	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00882-1
mdprc 052 07 18 000	Olympus	10mm 0Deg Infrared Telescope and 10mm 30Deg Infrared Telescope	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00841-1
mdprc 051 07 18 000	Philips Healthcare	Patient Supports for Stitching	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00881-1
mdprc 050 07 18 000	Vygon	Nutriline and Nutriline Twinflo Peripherally inserted central catheters (PICC)	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00842-1
mdprc 049 07 18 000	Vygon	Premicath Neonatal PICC with Stylet	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00478-1
mdprc 026 07 18 000	Ambu	AMBU Ultraseal II Anaesthetic Mask	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00799-1
mdprc 024 07 18 000	Baxter	In-Line Blood Set with Filter	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00783-1
mdprc 023 07 18 000	FUJIFILM	Synapse Cardiovascular (CV) Software	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00504-1
mdprc 022 07 18 000	Natus Medical	Xltek NeuroWorks Software	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00575-1
mdprc 021 07 18 000	NeoMed Inc.	NeoMed Enteral Feeding Tubes with EO Connectors	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00734-1
mdprc 020 07 18 000	NxStage Medical, Inc.	NxStage Express Fluid Warmer	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00798-1
mdprc 019 07 18 000	Starkey Laboratories	Earmoulds in use with children under 36 months	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00474-1
mdprc 018 07 18 000	Sunrise Medical	Zippie Zone Wheelchair	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00160-1
mdprc 007 07 18 000	Stryker Leibinger GmbH & Co.KG	QuikFlap Neuro Implants	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00682-1
mdprc 006 07 18 000	Zimmer Surgical Inc.	Dermatome AN	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00745-1
mdprc 063 06 17 001	Roche Diagnostics Corp	cobas omni MGP Reagent when used with cobas MPX assay (for use on the cobas 6800/8800 systems)	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-00744-1
mdprc 050 06 18 000	QIAGEN Ltd	EZ1 DSP Virus Kit (48)	http://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00659-1
mdprc 049 06 18 000	Medtronic SA	StraightShot Microdebrider Blades	http://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00675-1
mdprc 048 06 18 000	MAQUET Inc	VOLISTA STANOP, TRIPOD, ACCESS and QUICKLOCK Light heads	http://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00656-1
mdprc 047 06 18 000	Baxter Healthcare	FLOSEAL Special Applicator Tips	http://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00670-1
mdprc 046 06 18 000	SIEMENS	Symbia T and Symbia Intevo Systems Using CARE Dose4D Algorithms.	http://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00654-1
mdprc 081 10 17 001	Radiometer Inc.	Radiometer ABL800 series with FLEXQ module	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01316-1
mdprc 142 05 18 000	Stryker Orthopaedics	LFIT V40 Femoral Heads ..	http://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00639-1
mdprc 124 05 18 000	BioArray Solutions Ltd.	MIA FORA NGS HLA Server and Software versions 3.0 and 3.1.	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00403-1
mdprc 123 05 18 000	Biomet 3i Inc.	Tapered Screw-Vent Implants with 0.5 mm Machined Collar, MTX Surface and Microgrooves	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00509-1
mdprc 122 05 18 000	Phoenix Srl	Arcomed Volumed Set for Pump Type Volumed µVP 5005/7000 PVC and Gravity Use	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00367-1
mdprc 121 05 18 000	Remel Inc.	R30855101 - Salmonella paratyphi A-H Stained Suspension.	Medical supplies & Services Co.Ltd Mediserv
mdprc 114 06 16 001	ConMed Corporation	CORE Suction Irrigation Handpieces	http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-00844-1
mdprc 084 05 18 000	Medtronic	Clip Gun Magazines	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00488-1
mdprc 065 05 18 000	Roche Diagnostics	Accu-Chek Inform II test	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00417-1
mdprc 037 05 18 000	Oxoid Ltd Div Thermo Fisher Scientific Inc.	OXOID AST DISC CT0159B – Oxacillin OX1	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00361-1
mdprc 036 05 18 000	O-Two Medical Technologies, Inc.	Nitrous Oxide/Oxygen Analgesic Gas Mixing and Delivery System	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00406-1
mdprc 035 05 18 000	Ethicon Inc.	HARMONIC ACE + Shears with Adaptive Tissue Technology	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00446-1
mdprc 013 05 18 000	Dräger	Dräger Carina Ventilator	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00394-1
mdprc 012 05 18 000	Carl Zeiss	CLARUS 500	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00350-1
mdprc 154 04 18 000	FUJIFILM Corporation	FUJIFILM General X-ray System FDR Smart f series	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00351-1
mdprc 153 04 18 000	Medicina	Medicina Nasogastric Tubes	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00269-1
mdprc 152 04 18 000	TriMed	Nitinol Staples / Elastic Staples - Large and Small Symmetrical	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00354-1
mdprc 151 04 18 000	Wright Medical	Aequalis Humeral Nail Drill Bit	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00336-1
mdprc 101 04 18 000	Stryker Medtech	Sonopet Ultrasonic Products	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00323-1
mdprc 100 04 18 000	Gyrus ACMI	Classic Series Reusable Active Cord designed to be used with Gyrus ACMI FOCUS 640, Bovie and other general purpose monopolar electrosurgical generators	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00326-1
mdprc 092 04 18 000	Edwards Lifesciences	IntraClude Intra-aortic Occlusion Device	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00313-1
mdprc 091 04 18 000	Phadia AB	EliA Intrinsic Factor Well	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00317-1
mdprc 090 04 18 000	Philips Healthcare	Philips Ingenuity Core (728321)	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00312-1
mdprc 058 03 17 001	CareFusion	Thoracentesis/paracentesis kit,Illinois needle aspiration,Jamshidi needle bone marrow	http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2017-RN-00350-1
mdprc 029 03 18 001	Medtronic	MindFrame Capture LP Devices	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00194-2
mdprc 020 04 18 000	Getinge Sterilization AB	Getinge Sterilizer	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00196-1
mdprc 019 04 18 000	Welch Allyn	Spot Vision Screener 100	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00138-1
mdprc 049 03 18 002	Deerfield Imaging	IMRIS ORT100 and ORT300 Operating Room Tables	https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=162121
mdprc 118 03 18 000	Medtronic	Covidien LigaSure Exact Dissector Nano-Coated 20.6mm-21cm	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00261-1
mdprc 117 03 18 000	Remel Inc.	Thermo Scientific Remel Neisseria meningitidis Poly A-D 2mL and Neisseria meningitidis Group D 2mL.	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00201-1
mdprc 116 03 18 000	Well Lead Medical Co Ltd	Elongated Adult Non Rebreathe Mask	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00260-1
mdprc 114 03 18 000	HemoCue AB	HemoCue WBC Diff analysers and WBC Diff Microcuvettes	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00161-1
mdprc 077 03 18 000	Philips Healthcare	Ingenuity TF PET/CT System with Addonics Mass Storage Device (MSD)	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00233-1
mdprc 076 03 18 000	Zimmer Biomet, Inc.	EBI OsteoGen Implantable Bone Growth Stimulator	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00210-1
mdprc 074 03 18 000	Intuitive Surgical Inc.	da Vinci X Patient Side Cart Arm Controller Joint Circuit Boards	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00231-1
mdprc 073 03 18 000	Transonic Systems Inc.	ADT1018 and ADT1018-50 Flow QC Tubing – haemodialysis blood tubing Set	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00220-1
mdprc 100 08 17 001	Beckman Coulter	AQUIOS CL Flow Cytometry System.	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01101-1
mdprc 048 03 18 000	Sofradim Production	Versate Monofilament Mesh, 50x50 cm	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00191-1
mdprc 039 03 18 000	Evolutis	HACTIV Calcar reamers	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00156-1
mdprc 090 12 17 001	Siemens Healthcare Diagnostics	IMMULITE/IMMULITE 1000 IMMULITE 2000/IMMULITE 2000 XPi Assays	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01516-1
mdprc 004 03 18 000	3M Health Care Ltd	Futuro Quick Strap Ankle Support	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00098-1
mdprc 003 03 18 000	Cook Medical	Cook Aspiration Unit	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00174-1
mdprc 002 03 18 000	Jolife AB	LUCAS 2 Chest Compression System	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00147-1
mdprc 001 03 18 000	Tae-Chang Industrial Co.	U-100 Insulin Syringe 0.5mL 27G and 29G	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00171-1
mdprc 061 01 18 001	Allen Medical Systems	Radiolucent Spine Surgery Frame	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00024-1
mdprc 089 02 18 000	Arjo Huntleigh	Enterprise and Citadel Range Beds	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01199-1
mdprc 088 02 18 000	Mathys Ltd Bettlach	balanSys UNI convex PE inlay x/6, x/7, x/9	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00096-1
mdprc 086 02 18 000	SIEMENS	Biograph Horizon with VJ20A Software	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00126-1
mdprc 085 02 18 000	Southwest Technologies	Hypothermia Caps, Mittens and Slippers	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00121-1
mdprc 077 02 18 000	SPINEART	Small Pedicle Probe ELL-IN 02 23-N	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00087-1
mdprc 076 02 18 000	SIEMENS	Biograph mMR with software version syngo E11P	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00113-1
mdprc 075 02 18 000	SIEMENS	ACUSON SC2000 ultrasound systems	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00115-1
mdprc 074 02 18 000	MAQUET Inc	Maquet PowerLED, HLED 700 SF and Volista 600SF Surgical Lighting Systems	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00120-1
mdprc 073 02 18 000	Life Technologies Limited.	Foetal Haemoglobin Monoclonal Antibody (HBF-1), FITC	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00125-1
mdprc 072 02 18 000	Beckman Coulter	Automate 1250 and 2550 Sample Processing Systems	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00084-1
mdprc 080 10 17 001	Radiometer	Radiometer TCM5 FLEX / BASIC Transcutaneous Monitor	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00081-1
mdprc 033 02 18 000	Signature Orthopaedics	Signature Ceramic Femoral Head	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00091-1
mdprc 032 02 18 000	Siemens Healthcare Diagnostics	Dimension Vista Calcium (CA) Flex reagent cartridge.	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00106-1
mdprc 031 02 18 000	Medline Industries Inc.	Unomedical ConvaTec Frazier Suction Handle (included in Foot Pack Health and Lower Extremity Procedure Packs)	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00104-1
mdprc 027 02 18 000	Coloplast A/S	Biatain Ag Cavity Filler	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00086-1
mdprc 026 02 18 000	Medtronic	Valleylab FT10 energy platform	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00094-1
mdprc 001 02 18 000	GCMedica Enterprise Ltd	Fraizer suction handle	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00061-1
mdprc 091 05 17 001	Zimmer inc.	Affixus Hip Fracture Nail	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-00559-1
mdprc 092 12 17 002	Greiner Bio-One Inc	Vacuette Minicollect Complete 1mL Sodium Citrate 3.2%.	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01505-1
mdprc 069 01 18 001	Beckman Coulter	FC 500 Series Flow Cytometers	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00051-1
mdprc 084 01 18 000	QIAGEN Ltd	therascreen PyroMark Gold Q24 Reagents and Pyro Buffers	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00069-1
mdprc 079 01 18 000	SIEMENS	Artis one systems in conjunction with Artis tables	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00054-1
mdprc 076 01 18 000	HOLOGIC	Panther and Panther Fusion Systems with 19-in monitor	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00065-1
mdprc 075 01 18 000	Moog Inc.	Moog Infusion System Administration Sets	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00053-1
mdprc 059 01 18 000	Ningbo Runyes Medical Instrument Co Ltd	Runyes Autoclave	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00001-1
mdprc 057 01 18 000	Tornier Inc.	Multiple Tibial Implants	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00008-1
mdprc 056 01 18 000	DePuy Orthopaedics, Inc.	SIGMA HP Cemented Trochlea Implants	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00005-1
mdprc 055 01 18 000	COUSIN BIOTECH	NAJA Spinal Ligament Systems for Spinal Stabilization	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00007-1
mdprc 053 01 18 000	Beckman Coulter	Synchron Enzyme Validator	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-00018-1
mdprc 039 01 18 000	Salter Labs	Oxygen Cannulas	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01545-1
mdprc 117 12 17 000	Philips Healthcare	Ingenuity TF PET/CT	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01541-1
mdprc 107 12 17 000	BioMerieux Inc.	ETEST Teicoplanin 256 (TP) SPB and Foam packaging.	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01530-1
mdprc 106 12 17 000	Coloplast	Restorelle DirectFix Anterior, Restorelle DirectFix Posterior, and Altis Single Incision Sling	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01542-1
mdprc 105 12 17 000	Medos International SARL	DePuy Synthes Confidence Kit Spinal Cement System	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01534-1
mdprc 104 12 17 000	SynCardia Systems Inc.	SynCardia Freedom Driver System	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01528-1
mdprc 096 12 17 000	BEKA Hospitec GmbH	C- Series lifts	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01450-1
mdprc 095 12 17 000	Boston Scientific	Nv Guider Catheter 90cm	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01517-1
mdprc 094 12 17 000	Boston Scientific	Uphold LITE with Capio SLIM and Solyx Single Incision Sling System ,	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01508-1
mdprc 093 12 17 000	Cook Inc.	Transseptal Needle	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01503-1
mdprc 091 12 17 000	O-Two Medical Technologies, Inc.	Equinox Advantage- Nitrous Oxide/Oxygen Analgesic Gas Mixing and Delivery System	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01485-1
mdprc 050 12 17 000	MAKO Surgical Corp	MCK Tibial Baseplate-RM/LL-SZ 2 and MCK Tibial Baseplate-RM/LL-SZ 7	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01493-1
mdprc 049 12 17 000	Waverley Glen Systems Ltd	C-Series Lifts	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01442-1
mdprc 048 12 17 000	R & R Healthcare Equipment Pty Ltd	Hercules Patient Lifter	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01492-1
mdprc 046 12 17 000	Dako North America Inc.	Monoclonal Mouse Anti-Human CDX2, Clone DAK-CDX2.	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01482-1
mdprc 045 12 17 000	BioArray Solutions Ltd	MIA FORA NGS HLA FLEX 11 KIT (24 tests).	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01491-1
mdprc 023 12 17 000	AirSep Corporation	Airsep Impulse Elite	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01448-1
mdprc 022 12 17 000	Edwards Lifesciences	Intro-Flex Automatic Hemostasis Valve Introducer	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01488-1
mdprc 021 12 17 000	Balt Extrusion	Balt Cristal Balloons	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01483-1
mdprc 020 12 17 000	Cook Medical	Various Vital-Port Vascular Access Systems	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01453-1
mdprc 019 12 17 000	Phadia Ltd	Phadia Prime with software up to and including version 2.1.4	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01452-1
mdprc 011 12 17 000	Intelerad Medical Systems Inc.	IntelePACS with software versions 4-3-1 and up	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01434-1
mdprc 005 12 17 000	RaySearch Laboratories AB	RayStation and RayPlan	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01436-1
mdprc 012 06 17 001	Siemens Healthcare Diagnostics	N Antiserum to Human Ceruloplasmin	https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=156195
mdprc 121 11 17 000	Beckman Coulter…	Remisol Advance Software Versions Used with Abbott Architect Instruments	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01404-1
mdprc 120 11 17 000	Covidien LLC	Rechargeable Li-Ion Batteries with incorrect firmware used in Puritan Bennett 980 Ventilators	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01429-1
mdprc 119 11 17 000	Global Manufacturing Technology	Global Cup Poly Liner, Neutral prostheses	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01262-1
mdprc 118 11 17 000	Implant Direct Sybron Manufacturing,LLC	Spectra System/Legacy Guided Surgery Handle Kit Inserts	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01423-1
mdprc 117 11 17 000	Life Technologies Corporation	Foetal Haemoglobin Monoclonal Antibody (HBF-1).	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01414-1
mdprc 116 11 17 000	Seqirus Pty Ltd	Epiclone Anti-M Blood Grouping Reagent.	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-00817-1
mdprc 115 11 17 000	Seqirus Pty Ltd	Epiclone Anti-M Blood Grouping Reagent	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01361-1
mdprc 114 11 17 000	Stryker Howmedica Osteonics Corp	METS Principal Shaft	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01412-1
mdprc 060 11 17 000	William Cook Europe ApS	Disposable Reuter Tip-Deflecting Wire Guide	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01390-1
mdprc 001 09 14 001	Siemens Healthcare Diagnostics GmbH	Dimension Vista Hemoglobin A1c (HbA1c)	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01393-1
mdprc 059 11 17 000	Remel Inc.	Thermofisher Remel Bactipstaph Latex Kits	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01410-1
mdprc 058 11 17 000	Physio Control Inc	Infant/Child Reduced Energy Defibrillation Electrodes Used with LIFEPAK Automatic External Defibrillators	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01389-1
mdprc 057 11 17 000	Hill-Rom, Inc. &Subsidiaries	Compella Air Surfaces Bed System (220 - 240 V, 50 Hz),	Arabian Medical Marketing Co. (AMCO)
mdprc 056 11 17 000	Beckman Coulter	DxH 500 Open-Vial Haematology System	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01401-1
mdprc 055 11 17 000	DePuy International Limited	Acetabular Cup Introducer	http://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01385-1
mdprc 054 11 17 000	LivaNova Deutschland GmbH.	Sorin Group perfusion system – Heater Cooler 1T devices	http://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01370-1
mdprc 053 11 17 000	LivaNova Deutschland GmbH.	Sorin Group perfusion system – Heater Cooler 3T devices	http://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01368-1
mdprc 011 11 17 000	Actelion Pharmaceuticals	Veletri Consumables Kit with non Flow-Stop CADD Medication Cassette Reservoirs	http://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01369-1
mdprc 010 11 17 000	AGFA Corp.	Drystar DT 2 C Hardcopy Film 14" x 17"	http://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01371-1
mdprc 009 11 17 000	Dako Denmark A/S	FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor Clone EP1, Ready-to-use	http://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01330-1
mdprc 002 11 17 000	Stryker	rHead Radial Head and Uni-Elbow System	http://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01347-1
mdprc 118 10 17 000	Hospira Inc.	Plum 360 Infusion System	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01335-1
mdprc 105 10 17 000	BioArray Solutions Ltd	MIA FORA NGS	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01303-1
mdprc 104 10 17 000	Fresenius	Dialysis Treatment Therapy Pack 105	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01341-1
mdprc 099 10 17 000	Zevex International Inc.	Curlin 6000 Painsmart IOD Infusion Pump Power Adapter Accessory	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01324-1
mdprc 098 10 17 000	Stryker	Thoracic Pedicle Feeler	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01337-1
mdprc 097 10 17 000	Hospira Inc	Hospira labelled MedNet Medication Management Suite – with Plum 360 Infusion System	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01336-1
mdprc 082 10 17 000	Sunrise Medical	Oxford Dipper Hoist	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01233-1
mdprc 079 10 17 000	Liko AB	Liko Multirall 200 overhead lift and S65 Carriage	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01289-1
mdprc 073 10 17 000	Biomet 3i Inc.	Abut Gold Friction-Fit	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-00896-1
mdprc 072 10 17 000	Cepheid	Xpert EV Assay	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01257-1
mdprc 071 10 17 000	ICU Medical, Inc.	Various Safeset and Transpac Blood Pressure Transducer Sets	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01237-1
mdprc 070 10 17 000	Medtronic	O-arm O2 Surgical Imaging System	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01243-1
mdprc 048 10 17 000	MEDIPLAST AB	Various Disposable Catheter Mounts	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01268-1
mdprc 047 10 17 000	Sysmex America Inc	Fluorocell PLT reagent	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01275-1
mdprc 028 10 17 000	Bard Pcripheral Vascular (BPV)	Max-Core Disposable Core Biopsy Instruments	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01238-1
mdprc 027 10 17 000	Boston Scientific	Auriga XL 4007 Laser System	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01215-2
mdprc 026 10 17 000	Boston Scientific	Auriga XL 4007 Laser System	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01213-1
mdprc 025 10 17 000	Hill-Rom	Progressa Bed System	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01216-1
mdprc 024 10 17 000	Intelerad Medical Systems Inc.	IntelePACS InteleViewer	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01234-1
mdprc 023 10 17 000	SIEMENS	SOMATOM go.Up and SOMATOM go. Now	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01261-1
mdprc 022 10 17 000	SIEMENS	Multiple Artis systems	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01240-1
mdprc 060 09 17 000	iMDsoft Ltd	MetaVision ICU	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01173-2
mdprc 059 09 17 000	ThermoFisher Scientific Microbiology Perth	Oxoid AST Disc - Ceftazidime CAZ10	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01190-1
mdprc 058 09 17 000	St. Jude Medical Inc	NM Implantable Pulse Generator within the Infinity and Proclaim device families	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01184-1
mdprc 057 09 17 000	Siemens Medical Solutions	Artis zee and Artis Q systems with software version VD11C	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01186-1
mdprc 056 09 17 000	Radiometer America Inc	Radiometer AQT90FLEX Immunoassay analyser	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01195-1
mdprc 055 09 17 000	Oculentis	Lentis Foldable Intraocular Lenses (IOL)	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01194-1
mdprc 054 09 17 000	Mediplas Respiratory Products Sdn Bhd	Various Disposable Catheter Mounts	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01168-1
mdprc 053 09 17 000	Immucor GmbH.	Lifecodes HLA-DRB1 SSO Typing Kit and HLA-DQA1/B1 Typing Kit	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-00997-1
mdprc 052 09 17 000	Gainsky Pty Ltd	Freedom Healthcare Quad Walkers	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01130-1
mdprc 051 09 17 000	Bio-Rad Medical Diagnostics GmbH	DiaMed Q.C. System.	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01183-1
mdprc 033 09 17 000	Philips Healthcare	IntelliVue Patient Monitors Performing 12-Lead ECG Monitoring	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01171-1
mdprc 032 09 17 000	Thermo Fisher Scientific.	TM0268 GC Sugar Set	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01157-1
mdprc 031 09 17 000	Smiths Medical	Graseby 3300 Pump and Graseby 3000 Series Accessories	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01146-1
mdprc 030 09 17 000	Pride Mobility Products Ltd	Iris Hi Lo Bed	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-00842-1
mdprc 103 08 17 001	Thermo Fisher Scientific Inc.	Streptex Rapid Latex Agglutination Test.	Swissmedic
mdprc 013 09 17 000	Bayer Healthcare LLC.	Essure Permanent Birth Control.	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01125-1
mdprc 012 09 17 000	Stryker Howmedica Osteonics Corp	Mako THA Application User Guides	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01129-1
mdprc 061 08 17 001	Smith & Nephew inc	Polarstem Cardan for 21000438	https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=157987
mdprc 011 09 17 000	Siemens Medical Solutions	Artis one system with DP Transceiver below version 03	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01127-1
mdprc 010 09 17 000	Seqirus Pty Ltd	Epiclone Anti N BGR - Immunohaematology Reagent.	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-00754-1
mdprc 009 09 17 000	Ortho-Clinical Diagnostics	VITROS Immunodiagnostic Products Signal Reagent	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01090-1
mdprc 008 09 17 000	Hologic Inc	Affirm Lateral Arm Upright Biopsy Accessory (accessory to the Affirm Breast Biopsy Guidance System for Selenia Dimensions)	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-00988-1
mdprc 102 08 17 000	Thermo Fisher Scientific Inc.	Remel Wellcolex Colour Shigella Reagent	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01103-1
mdprc 101 08 17 000	Siemens Healthcare Diagnostics	Sysmex CS-5100 Analyser	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01098-1
mdprc 099 08 17 000	Applied Medical Resources	Kii Abdominal Troacar	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01102-1
mdprc 063 08 17 000	Vygon UK Ltd	XRO Umbilical Catheters	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01019-1
mdprc 062 08 17 000	The Binding Site	Human IgM kit for use on SPAPLUS	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-00916-1
mdprc 060 08 17 000	Smith & Nephew inc.	D-Rad Titanium 2.4mm x 10mm Locking Screw T7 Self-Tapping	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-00925-1
mdprc 059 08 17 000	Safapac Ltd	S7XTRA Concentrate 5 Litre bottles	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-00918-1
mdprc 058 08 17 000	PENTAX	Ultrasound Upper GI Video Scopes	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-00906-1
mdprc 056 08 17 000	Ortho-Clinical Diagnostics	VITROS Performance Verifier II	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01008-1
mdprc 055 08 17 000	Mediplas Respiratory Products Sdn Bhd	Disposable Expandable Adult 22mmID Expandable Anaesthetic Circuits	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01060-1
mdprc 054 08 17 000	Beckman Coulter	Gentian Cystatin C Calibrator Kit.	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-00992-1
mdprc 053 08 17 000	Abbott	Abbott RealTime HIV-1 Assay	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01057-1
mdprc 052 08 17 000	FUJIFILM Medical Systems	AMULET Digital Mammography Systems	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-00961-1
mdprc 009 08 17 000	Stanmore Implants	JTS System Grower Drive Units	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-00865-1
mdprc 008 08 17 000	Olympus	HF-Resection Electrodes	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-00863-1
mdprc 007 08 17 000	Maquet	Heater Unit HU 35	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-00917-1
mdprc 006 08 17 000	GE Healthcare	CareScape Patient Data Module (PDM) with software v2.6	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-00873-1
mdprc 005 08 17 000	FUJIFILM Medical Systems	Fujifilm Digital Mammography System	http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-00903-1