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Medical device recalls reported in 2018

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ReportedRecallClassProductFirm
2018-12-26Z-0497-2019Class IPuritan Bennett 980COVIDIEN LLC
2018-12-26Z-0609-2019Class IICarousel MAS1025-01Mazor Robotics Ltd
2018-12-26Z-0610-2019Class IIStaclot¿ LADiagnostica Stago, Inc.
2018-12-26Z-0611-2019Class IIStaclot LA 20Diagnostica Stago, Inc.
2018-12-26Z-0613-2019Class IIAIA-360 Analyzer is capable of performing two methods of immunoassay:…Tosoh Bioscience Inc
2018-12-26Z-0614-2019Class IIXper Flex Cardio Physiomonitoring SystemPhilips Electronics North America Corporation
2018-12-26Z-0615-2019Class IIAbbott i-STAT CG8+ Cartridges intended for use in the in vitro…Abbott Point Of Care Inc.
2018-12-26Z-0616-2019Class IIDimension Vista 500Siemens Healthcare Diagnostics, Inc.
2018-12-26Z-0617-2019Class IIDimension Vista 1500Siemens Healthcare Diagnostics, Inc.
2018-12-26Z-0618-2019Class IIVITEK 2 Antimicrobial Susceptibility TestingbioMerieux, Inc.
2018-12-26Z-0619-2019Class IISAPPHIRE Epidural Set Yellow-Striped MicroboreICU Medical Inc
2018-12-26Z-0620-2019Class IIultra2 Genesys Variants AnalyzerClark Laboratories, Inc. (dba,Trinity Biotech USA)
2018-12-26Z-0621-2019Class IIGenesys Analytical ColumnClark Laboratories, Inc. (dba,Trinity Biotech USA)
2018-12-26Z-0622-2019Class IIGenesys 1 ReagentClark Laboratories, Inc. (dba,Trinity Biotech USA)
2018-12-26Z-0623-2019Class IIGenesys 2 ReagentClark Laboratories, Inc. (dba,Trinity Biotech USA)
2018-12-26Z-0624-2019Class IIGenesys Diluent ReagentClark Laboratories, Inc. (dba,Trinity Biotech USA)
2018-12-26Z-0625-2019Class IICovidien Emprint Long Percutaneous Antenna with Thermosphere…Covidien LLC
2018-12-26Z-0626-2019Class IICovidien Emprint Short Percutaneous Antenna with Thermosphere…Covidien LLC
2018-12-26Z-0627-2019Class IICovidien Emprint Standard Percutaneous Antenna with Thermosphere…Covidien LLC
2018-12-26Z-0628-2019Class IIenVista One Piece Hydrophobic Acrylic Intraocular lensBausch & Lomb Surgical, Inc.
2018-12-26Z-0629-2019Class IIJarvik 2000 Ventricular Assist System external components: JHI-212 Y…Jarvik Heart Inc
2018-12-26Z-0630-2019Class IINexGen¿ Complete Knee Solution Femoral Augment Block Distal onlyZimmer Biomet, Inc.
2018-12-26Z-0631-2019Class IIProtexis Neoprene Surgical GloveCardinal Health 200, LLC
2018-12-26Z-0632-2019Class IIProtexis Neoprene Surgical GloveCardinal Health 200, LLC
2018-12-26Z-0633-2019Class IIProtexis Neoprene Surgical GloveCardinal Health 200, LLC
2018-12-26Z-0634-2019Class IIProtexis Neoprene Surgical GloveCardinal Health 200, LLC
2018-12-26Z-0635-2019Class IIProtexis Neoprene Surgical GloveCardinal Health 200, LLC
2018-12-26Z-0636-2019Class IIProtexis Neoprene Surgical GloveCardinal Health 200, LLC
2018-12-26Z-0637-2019Class IIProtexis Neoprene Surgical GloveCardinal Health 200, LLC
2018-12-26Z-0638-2019Class IIProtexis Neoprene Surgical GloveCardinal Health 200, LLC
2018-12-26Z-0639-2019Class IIVITEK¿ 2 Systems Software Version 9bioMerieux, Inc.
2018-12-26Z-0640-2019Class IIGloCyte RBC ReagentAdvanced Instruments, LLC
2018-12-26Z-0641-2019Class IICentricity Universal Viewer Zero Footprint ClientGE Healthcare, LLC
2018-12-26Z-0642-2019Class IIZimmer Compress Devices and Instruments: Item Number/Item Description…Zimmer Biomet, Inc.
2018-12-26Z-0643-2019Class IITheragenics Applicator NeedleTheragenics Corporation
2018-12-26Z-0644-2019Class IIAvenir¿ Muller Stem StandardZimmer GmbH
2018-12-26Z-0645-2019Class IIIMRIS T2X tableDeerfield Imaging, Inc.
2018-12-26Z-0646-2019Class IIIMRIS ORT 100 tableDeerfield Imaging, Inc.
2018-12-26Z-0647-2019Class IIIMRIS ORT 200Deerfield Imaging, Inc.
2018-12-26Z-0648-2019Class IIIMRIS ORT 300Deerfield Imaging, Inc.
2018-12-26Z-0649-2019Class IIFoundationOne CDx Test ResultsFoundation Medicine, Inc.
2018-12-26Z-0650-2019Class IIVITROS 5600 Integrated SystemOrtho-Clinical Diagnostics
2018-12-26Z-0651-2019Class IIVITROS 5Ortho-Clinical Diagnostics
2018-12-26Z-0652-2019Class IIVITROS¿ 3600 Immunodiagnostic SystemOrtho-Clinical Diagnostics
2018-12-26Z-0653-2019Class IIVITROS 4600 Chemistry SystemOrtho-Clinical Diagnostics
2018-12-26Z-0654-2019Class IIEmpower FastLoad CT Syringe Pack -sterile disposable syringe kit for…Bracco Injeneering S.A.
2018-12-26Z-0655-2019Class IIIRT-5100 RefractorNidek Inc.
2018-12-26Z-0656-2019Class II8Fr SAFE GRAD CAT W/ValveCOVIDIEN LLC
2018-12-26Z-0657-2019Class IIReliance LITe Nerve Hook BayonetedHowmedica Osteonics Corp.
2018-12-26Z-0658-2019Class IIOptiflux F160NR Capillary High Flux Dialyzer Single Use OnlyFresenius Medical Care Renal Therapies Group, LLC
2018-12-26Z-0659-2019Class IIBucky Stand SU-4000 Input 2017Konica Minolta Healthcare, Americas, Inc.
2018-12-19Z-0562-2019Class IICIVCO Needle Guide BracketCIVCO Medical Instruments Co., Inc.
2018-12-19Z-0563-2019Class IISonoSite L25 Bracket Kit containing 1 Reusable non-sterile bracketCIVCO Medical Instruments Co., Inc.
2018-12-19Z-0564-2019Class IICIVCO Needle Guide BracketCIVCO Medical Instruments Co., Inc.
2018-12-19Z-0565-2019Class IICIVCO Biopsy BracketCIVCO Medical Instruments Co., Inc.
2018-12-19Z-0566-2019Class IISonoSite Needle Guide BracketCIVCO Medical Instruments Co., Inc.
2018-12-19Z-0567-2019Class IISonoSite FUJIFILM Needle Guide BracketCIVCO Medical Instruments Co., Inc.
2018-12-19Z-0568-2019Class IICIVCO Needle Guide Starter KitCIVCO Medical Instruments Co., Inc.
2018-12-19Z-0569-2019Class IICIVCO Needle Guide Starter KitCIVCO Medical Instruments Co., Inc.
2018-12-19Z-0570-2019Class IICIVCO Needle Guide Starter KitCIVCO Medical Instruments Co., Inc.
2018-12-19Z-0571-2019Class IICIVCO Needle Guide Starter KitCIVCO Medical Instruments Co., Inc.
2018-12-19Z-0572-2019Class IICIVCO Needle Guide Starter KitCIVCO Medical Instruments Co., Inc.
2018-12-19Z-0573-2019Class IICIVCO Needle Guide Starter KitCIVCO Medical Instruments Co., Inc.
2018-12-19Z-0574-2019Class IICIVCO Needle Guide BracketCIVCO Medical Instruments Co., Inc.
2018-12-19Z-0575-2019Class IICIVCO Needle Guide BracketCIVCO Medical Instruments Co., Inc.
2018-12-19Z-0576-2019Class IICIVCO Sales Demo KitCIVCO Medical Instruments Co., Inc.
2018-12-19Z-0577-2019Class IILaser Fiber Assy-Single Use-LFS-272-RT-0Leoni Fiber Optics GmbH
2018-12-19Z-0578-2019Class IILaser Fiber Assy-Single Use-LFS-365-RT-0Leoni Fiber Optics GmbH
2018-12-19Z-0579-2019Class IILaser Fiber Assy-Single Use-LFS-550-RT-0Leoni Fiber Optics GmbH
2018-12-19Z-0580-2019Class IILaser Fiber Assy-Single Use-LFS-940-RT-0Leoni Fiber Optics GmbH
2018-12-19Z-0581-2019Class IILaser Fiber Assy-Single Use-LFS-200-0Leoni Fiber Optics GmbH
2018-12-19Z-0582-2019Class IIMedtronic HeartWare Ventricular Assist HVAD System Battery Charger…Heartware, Inc.
2018-12-19Z-0583-2019Class IIPROCARE B20 Patient MonitorGE Healthcare, LLC
2018-12-19Z-0584-2019Class IIPROCARE B40 Patient MonitorGE Healthcare, LLC
2018-12-19Z-0585-2019Class IIB20i Patient Monitor and B20i V2 Patient MonitorGE Healthcare, LLC
2018-12-19Z-0586-2019Class IIB40i Patient Monitor and B40i Patient Monitor V3 The device is a…GE Healthcare, LLC
2018-12-19Z-0587-2019Class IIB105/125 Patient MonitorGE Healthcare, LLC
2018-12-19Z-0588-2019Class IIGE LOGIQ E10 Ultrasound SystemGE Healthcare, LLC
2018-12-19Z-0589-2019Class IIARJOHUNTLEIGH GETINGE GROUP Flites Passive Clip SlingARJOHUNTLEIGH POLSKA Sp. z.o.o.
2018-12-19Z-0590-2019Class IIOrthopedic Salvage SystemZimmer Biomet, Inc.
2018-12-19Z-0591-2019Class IIComprehensive Mini StemZimmer Biomet, Inc.
2018-12-19Z-0592-2019Class IIIntelliVue MX40 Patient MonitorPhilips Electronics North America Corporation
2018-12-19Z-0593-2019Class IIStSt. Jude Medical, Inc.
2018-12-19Z-0594-2019Class IICascade Abrazo c-ACT-LR Test Card IVD FOR IN VITRO DIAGNOSTIC USE…Helena Laboratories, Inc.
2018-12-19Z-0595-2019Class IIXcela Power Injectable PICC with PASVAngiodynamics Inc. (Navilyst Medical Inc.)
2018-12-19Z-0596-2019Class IIBioFlo PICC with ENDEXO and PASVAngiodynamics Inc. (Navilyst Medical Inc.)
2018-12-19Z-0597-2019Class IISalem Sump Dual Lumen Stomach Tube 10 Fr/ChCOVIDIEN LLC
2018-12-19Z-0598-2019Class IIUroLift System REF Catalog Number: UL400-4 Tray Contents: UroLift…Neotract Inc
2018-12-19Z-0599-2019Class IIAIA-2000 AnalyzerTosoh Bioscience Inc
2018-12-19Z-0600-2019Class IIAIA-900AnalyzerTosoh Bioscience Inc
2018-12-19Z-0601-2019Class IIIHemoglobin A1c ControlTosoh Bioscience Inc
2018-12-19Z-0602-2019Class IIAIA-900 Automated Immunoassay Analyzer performs three methods of…Tosoh Bioscience Inc
2018-12-19Z-0603-2019Class IIHeartStart MRxPhilips North America LLC
2018-12-19Z-0604-2019Class IIBinding Site Human IgM KitThe Binding Site Group, Ltd.
2018-12-19Z-0605-2019Class IITritanium Posterior LumbarHowmedica Osteonics Corp.
2018-12-19Z-0606-2019Class IIDiscovery NM/CT 670 DRGE Healthcare, LLC
2018-12-19Z-0607-2019Class IIDiscovery NM/CT 670 ESGE Healthcare, LLC
2018-12-19Z-0608-2019Class IIDiscovery NM/CT 670 ProGE Healthcare, LLC
2018-12-12Z-0463-2019Class IGE HEALTHCARE CARESCAPE R860 Inspiratory Safety GuardGE Healthcare, LLC
2018-12-12Z-0525-2019Class IIFamily Wellness First Aid Sterile Gauze Pad 3 in x 3 inASO, LLC
2018-12-12Z-0526-2019Class IIINEOCONNECTNeomed Inc
2018-12-12Z-0527-2019Class IIOptional MDRC-1119 Front Cover Attachment Kit for review display…Barco N.V.
2018-12-12Z-0528-2019Class IIBD BBL Trypticase Soy Agar with 5% Sheep BloodBecton Dickinson & Co.
2018-12-12Z-0529-2019Class IIIGel Alkaline Phosphatase Isoenzyme Control Kit: Gel Alkaline…Helena Laboratories, Inc.
2018-12-12Z-0530-2019Class IIZimmer Pressure Sentinel¿ Intramedullary Reaming SystemZimmer Biomet, Inc.
2018-12-12Z-0531-2019Class IIZimmer M/DN¿ Intramedullary Fixation Humeral Guide WireZimmer Biomet, Inc.
2018-12-12Z-0532-2019Class IIZimmer M/DN¿ Intramedullary Fixation Humeral Guide WireZimmer Biomet, Inc.
2018-12-12Z-0533-2019Class IIZimmer ZMS¿ Intramedullary Fixation Smooth Guide WireZimmer Biomet, Inc.
2018-12-12Z-0534-2019Class IIZimmer ZMS¿ Intramedullary Fixation Smooth Guide WireZimmer Biomet, Inc.
2018-12-12Z-0535-2019Class IIZimmer ZMS¿ Intramedullary Fixation Smooth Guide WireZimmer Biomet, Inc.
2018-12-12Z-0536-2019Class IIZimmer Humeral Guide WireZimmer Biomet, Inc.
2018-12-12Z-0537-2019Class IIZimmer Smooth Guide WireZimmer Biomet, Inc.
2018-12-12Z-0538-2019Class IIZimmer Natural Nail¿ SystemZimmer Biomet, Inc.
2018-12-12Z-0539-2019Class IIZimmer Natural Nail¿ SystemZimmer Biomet, Inc.
2018-12-12Z-0540-2019Class IIZimmer Natural Nail¿ SystemZimmer Biomet, Inc.
2018-12-12Z-0541-2019Class IIZimmer Natural Nail¿ SystemZimmer Biomet, Inc.
2018-12-12Z-0542-2019Class IIZimmer Pressure Sentinel¿ Intramedullary Reaming SystemZimmer Biomet, Inc.
2018-12-12Z-0543-2019Class IIBrilliance 64Philips Medical Systems (Cleveland) Inc
2018-12-12Z-0544-2019Class IIBrilliance 40Philips Medical Systems (Cleveland) Inc
2018-12-12Z-0545-2019Class IIBrilliance 16 SlicePhilips Medical Systems (Cleveland) Inc
2018-12-12Z-0546-2019Class IIBrilliance 16 SlicePhilips Medical Systems (Cleveland) Inc
2018-12-12Z-0547-2019Class IIBrilliance 10 SlicePhilips Medical Systems (Cleveland) Inc
2018-12-12Z-0548-2019Class IIBrilliance 6 SlicePhilips Medical Systems (Cleveland) Inc
2018-12-12Z-0549-2019Class IIInvacare 9805 and 9805P Hydraulic Patient LiftsInvacare Corporation
2018-12-12Z-0550-2019Class IICaptus 3000 Thyroid Uptake SystemCapintec Inc
2018-12-12Z-0551-2019Class IICaptus 700 Thyroid Uptake SystemCapintec Inc
2018-12-12Z-0553-2019Class IIBiomet 20mm Compress Device Short Anchor Plug With Drill Set / With…Zimmer Biomet, Inc.
2018-12-12Z-0554-2019Class IIThermacare Muscle Pain Therapy HeatWraps: a) UPC 0573301314 b) UPC…Pfizer Inc.
2018-12-12Z-0555-2019Class IIThermacare HeatWraps Menstrual a) UPC 0573302002 b) UPC 0573302044…Pfizer Inc.
2018-12-12Z-0556-2019Class IIThermacare HEATWRAPS JOINT PAIN THERAPYPfizer Inc.
2018-12-12Z-0557-2019Class IISTEPHANIX D2RS Digital Dynamic Remote Systemhttp://ctsStephanix
2018-12-12Z-0558-2019Class IIArtis Zee and ZeegoSiemens Medical Solutions USA, Inc
2018-12-12Z-0559-2019Class IIAIA-360 AnalyzerTosoh Bioscience Inc
2018-12-12Z-0560-2019Class IIAtrium 28Fr PVC Thoracic Catheter RIGHT ANGLEAtrium Medical Corporation
2018-12-12Z-0561-2019Class IICascade Abrazo c-ACT-LR Test Card IVD FOR IN VITRO DIAGNOSTIC USE…Helena Laboratories, Inc.
2018-12-05Z-0436-2019Class IQUADROX-i Neonatal without integrated arterial filter and VHK 11000Maquet Cardiovascular Us Sales, Llc
2018-12-05Z-0437-2019Class IQUADROX-i Neonatal with integrated arterial filter and VHK 11000Maquet Cardiovascular Us Sales, Llc
2018-12-05Z-0470-2019Class IBrightMatter GuideSynaptive Medical Inc
2018-12-05Z-0498-2019Class IIReprocessed Xcel Bladeless TrocarStryker Sustainability Solutions
2018-12-05Z-0499-2019Class IIDimension Vista Lactate DehydrogenaseSiemens Healthcare Diagnostics, Inc.
2018-12-05Z-0500-2019Class IINxStage PureFlow B Solution-RFP-400NxStage Medical, Inc.
2018-12-05Z-0501-2019Class IINxStage PureFlow B Solution-RFP-401NxStage Medical, Inc.
2018-12-05Z-0502-2019Class IINxStage PureFlow B Solution-RFP-402NxStage Medical, Inc.
2018-12-05Z-0503-2019Class IINxStage PureFlow B Solution-RFP-403NxStage Medical, Inc.
2018-12-05Z-0504-2019Class IINxStage PureFlow B Solution-RFP-404NxStage Medical, Inc.
2018-12-05Z-0505-2019Class IINxStage PureFlow B Solution-RFP-406NxStage Medical, Inc.
2018-12-05Z-0506-2019Class IINxStage PureFlow B Solution-RFP-RFP-454NxStage Medical, Inc.
2018-12-05Z-0507-2019Class IINxStage PureFlow B Solution-RFP-RFP-456NxStage Medical, Inc.
2018-12-05Z-0508-2019Class IIPNEUMOCLEAR Heated High-Flow Tube Set Product Usage: The Heated…WOM World of Medicine AG
2018-12-05Z-0509-2019Class IIAIA-900 Automated Immunoassay AnalyzerTosoh Bioscience Inc
2018-12-05Z-0510-2019Class IIMulti-Track Angiographic CatheterNumed Inc
2018-12-05Z-0511-2019Class IIMulti-Track Angiographic CatheterNumed Inc
2018-12-05Z-0512-2019Class IIMedex High Pressure Stopcock used to control the direction of IV…Smiths Medical ASD Inc.
2018-12-05Z-0513-2019Class IIPerkinElmer QSight 210 MD Mass Spectrometer Simplicity 3Q MD v1PerkinElmer Health Sciences Canada, Inc.
2018-12-05Z-0514-2019Class IIHemoTrol Level 2- In Vitro Diagnostic Hematology quality control…EUROTROL INC
2018-12-05Z-0515-2019Class IIHemoTrol Level 3- In Vitro Diagnostic Hematology quality control…EUROTROL INC
2018-12-05Z-0516-2019Class IIIFresenius Granuflo Dry Acid Concentrate- 2K 2Fresenius Medical Care Renal Therapies Group, LLC
2018-12-05Z-0517-2019Class IIIFresenius Granuflo Dry Acid Concentrate- 2K 2Fresenius Medical Care Renal Therapies Group, LLC
2018-12-05Z-0518-2019Class IIIFresenius Granuflo Dry Acid Concentrate- 3K 2Fresenius Medical Care Renal Therapies Group, LLC
2018-12-05Z-0519-2019Class IIDash 3000 Patient Monitoring System is used to monitor physiologic…GE Healthcare, LLC
2018-12-05Z-0520-2019Class IIDash 4000 Patient Monitoring System is used to monitor physiologic…GE Healthcare, LLC
2018-12-05Z-0521-2019Class IIDash 5000 Patient Monitoring System is used to monitor physiologic…GE Healthcare, LLC
2018-12-05Z-0522-2019Class IISolar 8000i Patient Monitoring System is used to monitor physiologic…GE Healthcare, LLC
2018-12-05Z-0523-2019Class IISolar 8000M Patient Monitoring System is used to monitor physiologic…GE Healthcare, LLC
2018-12-05Z-0524-2019Class IISolar 9500 Information Monitoring System is used to monitor…GE Healthcare, LLC
2018-11-28Z-0388-2019Class IIDeltaVision OMX SR Imaging System Model Number: 29115476 The…GE Healthcare Biosciences
2018-11-28Z-0471-2019Class I1) Cytomics FC 500 With CXP Software BECKMAN COULTER 2) Cytomics FC…Beckman Coulter Inc.
2018-11-28Z-0472-2019Class ICOULTER EPICS XL Flow Cytometer COULTER EPICS XL-MCL Flow Cytometer…Beckman Coulter Inc.
2018-11-28Z-0473-2019Class IILeMaitre Vascular Pruitt F3¿-S Polyurethane Outlying Carotid ShuntLeMaitre Vascular, Inc.
2018-11-28Z-0474-2019Class IIThe SQ-RX Pulse Generator a component of the Subcutaneous Implantable…Boston Scientific Corporation
2018-11-28Z-0475-2019Class IIAIA-2000 AnalyzerTosoh Bioscience Inc
2018-11-28Z-0476-2019Class IIVITROS¿ Chemistry Products dLDL Reagent-GENs 26 & 27Ortho-Clinical Diagnostics
2018-11-28Z-0477-2019Class IIBinding Site Human IgM KitThe Binding Site Group, Ltd.
2018-11-28Z-0478-2019Class IIInsulia Diabetes Management CompanionVoluntis
2018-11-28Z-0479-2019Class IIGiraffe OmniBed CarestationGE Healthcare, LLC
2018-11-28Z-0480-2019Class IIGiraffe Incubator CarestationGE Healthcare, LLC
2018-11-28Z-0481-2019Class IIGiraffe WarmerGE Healthcare, LLC
2018-11-28Z-0482-2019Class IIPanda iRes Infant Radiant WarmerGE Healthcare, LLC
2018-11-28Z-0483-2019Class IIPanda Freestanding WarmerGE Healthcare, LLC
2018-11-28Z-0484-2019Class IIPanda Wall Mount warmerGE Healthcare, LLC
2018-11-28Z-0485-2019Class IITosoh AIA-900 immunoassay AnalyzerTosoh Bioscience Inc
2018-11-28Z-0486-2019Class IIAscom Telligence Nurse Call SystemAscom (US) Inc.
2018-11-28Z-0487-2019Class IIPremierPro Aluminum Adjustable WalkerSVS LLC
2018-11-28Z-0488-2019Class IISedecal NOVA FA DR SystemSedecal S.A.
2018-11-28Z-0489-2019Class IIMinicon Clinical Sample Concentrators for In Vitro Diagnostic Use 9031Merck Millipore Ltd.
2018-11-28Z-0490-2019Class IIIrrisept ORMedex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company
2018-11-28Z-0491-2019Class IIBD Vacutainer Urine Collection CupsBecton Dickinson & Company
2018-11-28Z-0492-2019Class IIBD Vacutainer Specimen Collection CupsBecton Dickinson & Company
2018-11-28Z-0493-2019Class IIKIT URIN CUP PLC 16X100 10Becton Dickinson & Company
2018-11-28Z-0494-2019Class IIKIT URIN CUP 16X100 8Becton Dickinson & Company
2018-11-28Z-0495-2019Class IIVanguard Knee System -PS Open Box Femoral LeftZimmer Biomet, Inc.
2018-11-28Z-0496-2019Class IIVanguard Knee System -PS Open Box Femoral RightZimmer Biomet, Inc.
2018-11-21Z-0369-2019Class IGE Healthcare Millennium MyoSIGHT Nuclear Cardiology Imaging System…GE Healthcare, LLC
2018-11-21Z-0370-2019Class IGE Healthcare Millennium MG Multi-Geometry Digital CSE Dual Detector…GE Healthcare, LLC
2018-11-21Z-0371-2019Class IGE Healthcare Millennium MCGE Healthcare, LLC
2018-11-21Z-0411-2019Class IIAisys Anesthesia SystemGE Healthcare, LLC
2018-11-21Z-0412-2019Class IIAisys CS2 Anesthesia SystemGE Healthcare, LLC
2018-11-21Z-0413-2019Class IITouchscreen display kitGE Healthcare, LLC
2018-11-21Z-0414-2019Class IIIBioMend ExtendCollagen Matrix, Inc.
2018-11-21Z-0415-2019Class IIOviTex Reinforced BioScaffold 4x8cmAROA Biosurgery, LTD.

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