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Medical device recalls reported in 2017

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ReportedRecallClassProductFirm
2017-07-19Z-2693-2017Class IIInfinity 5St. Jude Medical, Inc.
2017-07-19Z-2694-2017Class IIInfinity 5St. Jude Medical, Inc.
2017-07-19Z-2695-2017Class IIInfinity 7St. Jude Medical, Inc.
2017-07-19Z-2696-2017Class IIInfinity 7St. Jude Medical, Inc.
2017-07-19Z-2697-2017Class IILeksell Gamma Knife Icon is a teletherapy device intended for…Elekta, Inc.
2017-07-19Z-2698-2017Class IIArrow EVOLUTION Pressure Injectable PICC with Chlorag+ard…Arrow International Inc
2017-07-19Z-2699-2017Class IIArrow Glide Thru Peel-Away Sheath/Dilator IntroducerArrow International Inc
2017-07-19Z-2700-2017Class IIAlaris Pump Module model 8100CareFusion 303, Inc.
2017-07-19Z-2701-2017Class IIThe Olympic Pasteurmatic 3000 and Olympic Pasteurmatic 3500 are…Natus Medical Incorporated
2017-07-19Z-2703-2017Class IICarestation 620 A1GE Healthcare, LLC
2017-07-19Z-2704-2017Class IIExactech Optetrak Logic CC 15mm Tibial Augment ScrewsExactech, Inc.
2017-07-19Z-2705-2017Class IIO-Two Adult Ventilation TimerO-Two Medical Technologies, Inc.
2017-07-19Z-2706-2017Class IIUltrasonic Endoscope Model Number EG-530UT A flexible ultrasonic…Fujifilm Medical Systems U.S.A., Inc.
2017-07-19Z-2707-2017Class IIThe Schiller PB 1000Merge Healthcare, Inc.
2017-07-19Z-2708-2017Class IIXARIO 100 TUS-X100 diagnostic ultrasound systemToshiba American Medical Systems Inc
2017-07-19Z-2709-2017Class IIXARIO 200 TUS-X200 diagnostic ultrasound systemToshiba American Medical Systems Inc
2017-07-19Z-2710-2017Class IIAPLIO 300 TUS-A300 diagnostic ultrasound systemToshiba American Medical Systems Inc
2017-07-19Z-2711-2017Class IIAPLIO 500 TUS-A500 diagnostic ultrasound systemToshiba American Medical Systems Inc
2017-07-19Z-2712-2017Class IIAPLIO i-series: a) APLIO i700 TUS AI700 b) APLIO i800 TUS AI800…Toshiba American Medical Systems Inc
2017-07-19Z-2713-2017Class IIVideo Duodenoscope These instruments are intended to provide optical…Pentax of America Inc
2017-07-19Z-2714-2017Class IIArjoHuntleigh Flowtron ACS900Arjo, Inc. dba ArjoHuntleigh
2017-07-19Z-2715-2017Class IIOn-X Prosthetic Heart Valve Product Usage: Indicated for the…CryoLife, Inc.
2017-07-19Z-2716-2017Class II18 cmICU Medical, Inc.
2017-07-19Z-2717-2017Class II168 cmICU Medical, Inc.
2017-07-19Z-2718-2017Class II28 cmICU Medical, Inc.
2017-07-19Z-2719-2017Class II28 cmICU Medical, Inc.
2017-07-19Z-2720-2017Class IIPROXIMALEICU Medical, Inc.
2017-07-19Z-2721-2017Class IIKit w/3 Ext SetsICU Medical, Inc.
2017-07-19Z-2722-2017Class II10" Smallbore Ext Set w/6-Port NanoClave¿ ManifoldICU Medical, Inc.
2017-07-19Z-2723-2017Class II10" Smallbore Ext Set w/6-Port NanoClave¿ ManifoldICU Medical, Inc.
2017-07-19Z-2724-2017Class II10" Smallbore Ext Set w/6-Port NanoClave¿ ManifoldICU Medical, Inc.
2017-07-19Z-2725-2017Class IIIMedica ISE Module Calibrant AAMS Diagnostics, LLC
2017-07-19Z-2726-2017Class IINicolet¿ Elite¿ 2 MHz OB ProbeNatus Neurology Inc
2017-07-19Z-2727-2017Class IINicolet¿ Elite¿ 2 MHz OB Water Proof ProbeNatus Neurology Inc
2017-07-19Z-2728-2017Class IINicolet¿ Elite¿ 3 MHz OB ProbeNatus Neurology Inc
2017-07-19Z-2729-2017Class IINicolet¿ Elite¿ 5 MHz Vascular ProbeNatus Neurology Inc
2017-07-19Z-2730-2017Class IIBeckman Coulter Synchron AQUA CAL Level 1Beckman Coulter Inc
2017-07-19Z-2731-2017Class IIBurn Relief¿O-Two Medical Technologies, Inc.
2017-07-19Z-2732-2017Class IINova Biomedical Stat Profile Prime Analyzer as follows: PN 52855 Stat…Nova Biomedical Corporation
2017-07-19Z-2733-2017Class IATAR Disposable Extension CableOscor, Inc.
2017-07-12Z-2645-2017Class IIBoston Scientific Imager II Angiographic CatheterBoston Scientific Corporation
2017-07-12Z-2656-2017Class IIDrew Scientific DREW 3-PAC Reagent Kit containing: 5L DiluentJAS Diagnostics Inc.
2017-07-12Z-2657-2017Class IICardioTek EP-TRACER Software V1CardioTek BV
2017-07-12Z-2658-2017Class II3DKNEEEncore Medical, Lp
2017-07-12Z-2659-2017Class II3DKNEEEncore Medical, Lp
2017-07-12Z-2660-2017Class IINussloch GmbH ASP6025 Tissue ProcessorLeica Microsystems, Inc.
2017-07-12Z-2661-2017Class IIMedacta GMK HINGEMedacta Usa Inc
2017-07-12Z-2662-2017Class IILogic Fit Tibial Tamp HeadExactech, Inc.
2017-07-12Z-2663-2017Class IIEXACTECH Equinoxe Reverse Starter ReamerExactech, Inc.
2017-07-12Z-2664-2017Class IIEXACTECH Equinoxe Glenoid ReamerExactech, Inc.
2017-07-12Z-2665-2017Class IIEXACTECH Equinoxe Modular Reverse Pilot-Tip Starter ReamerExactech, Inc.
2017-07-12Z-2666-2017Class IIEXACTECH Equinoxe Modular Reverse Pilot-Tip ReamerExactech, Inc.
2017-07-12Z-2667-2017Class IIEXACTECH Equinoxe Narrow Modular Reverse Pilot-Tip Starter Reamer…Exactech, Inc.
2017-07-12Z-2668-2017Class IIEXACTECH Equinoxe Narrow Modular Reverse Pilot-Tip Reamer // Catalog…Exactech, Inc.
2017-07-12Z-2669-2017Class IIElectrophysiology catheter cables are designed as electrode cables…Sterilmed Inc
2017-07-12Z-2670-2017Class IIJelcoSmiths Medical ASD Inc.
2017-07-12Z-2671-2017Class IIAlaris PC UnitCareFusion 303, Inc.
2017-07-12Z-2672-2017Class IIProteus 235 and Proteus ONE proton therapy systemsIon Beam Applications S.A.
2017-07-12Z-2673-2017Class IIBoston Scientific Extractor Pro RX-S Retrieval Balloon Catheter…Boston Scientific Corporation
2017-07-12Z-2674-2017Class IIBoston Scientific Extractor Pro RX-S Retrieval Balloon Catheter…Boston Scientific Corporation
2017-07-12Z-2684-2017Class IIProteus 235Ion Beam Applications S.A.
2017-07-12Z-2685-2017Class IIMultiphor II Electrophoresis System GE HealthCare Product Number:…Perkinelmer Life Sciences, Inc.
2017-07-12Z-2687-2017Class IITenaxis Medical ArterXMallinckrodt Manufacturing LLC
2017-07-12Z-2688-2017Class IISensis Vibe Systems with Software Version VD10BSiemens Medical Solutions USA, Inc
2017-07-12Z-2689-2017Class IICoulter PrepPlusBeckman Coulter Inc.
2017-07-12Z-2690-2017Class IICoulter PrepPlus 2Beckman Coulter Inc.
2017-07-05Z-2622-2017Class IICovidien Endo Peanut 5mm Auto Suture Blunt Dissector Item Code:…Covidien LLC
2017-07-05Z-2623-2017Class IIBioGlue Surgical AdhesiveCryoLife, Inc.
2017-07-05Z-2624-2017Class IILEGIONSmith & Nephew, Inc.
2017-07-05Z-2625-2017Class IILEGIONSmith & Nephew, Inc.
2017-07-05Z-2626-2017Class IIROTH MOBELI Grab Handles used with EOS System: MOBELI Stabi Vario…EOS Imaging
2017-07-05Z-2627-2017Class IIIDIASTATEuro Diagnostica AB
2017-07-05Z-2628-2017Class IIMerge LIS softwareMerge Healthcare, Inc.
2017-07-05Z-2629-2017Class IIHigh Frequency Resection ElectrodesOlympus Corporation of the Americas
2017-07-05Z-2630-2017Class IIda Vinci Xi Surgical System Product Usage: The da Vinci Xi Surgical…Intuitive Surgical, Inc.
2017-07-05Z-2631-2017Class IIIPointe Scientific CRPMedtest Holdings, Inc.
2017-07-05Z-2632-2017Class II3M Ranger3M Company - Health Care Business
2017-07-05Z-2633-2017Class IIMOSAIQElekta, Inc.
2017-07-05Z-2634-2017Class IITI Transport Monitor/Module Battery Pack Product Usage: intended for…Mindray DS USA, Inc. dba Mindray North America
2017-07-05Z-2635-2017Class IIAccess Total T3Beckman Coulter Inc.
2017-07-05Z-2636-2017Class IIAccess ThyroglobulinBeckman Coulter Inc.
2017-07-05Z-2637-2017Class IIAccess System-Free T4 AssayBeckman Coulter Inc.
2017-07-05Z-2638-2017Class IIAccess System-GI MonitorBeckman Coulter Inc.
2017-07-05Z-2639-2017Class IIDeRoyalDeRoyal Industries Inc
2017-07-05Z-2640-2017Class IISpO2 connecting cable for Masimo LNCS sensorMerge Healthcare, Inc.
2017-07-05Z-2641-2017Class IIMasimo SPO2 SensorMerge Healthcare, Inc.
2017-07-05Z-2642-2017Class IIMasimoSET LNOP DCIP pediatric/slender digit SpO2 reusable sensorMerge Healthcare, Inc.
2017-07-05Z-2643-2017Class IIMasimoSET LNOP DCI adult SpO2 reusable sensorMerge Healthcare, Inc.
2017-07-05Z-2644-2017Class IIExactech 1Exactech, Inc.
2017-07-05Z-2646-2017Class IIELEOS LIMB SALVAGE SYSTEM SEGMENTAL STEMOnkos Surgical, Inc.
2017-07-05Z-2647-2017Class IIELEOS LIMB SALVAGE SYSTEM SEGMENTAL STEMOnkos Surgical, Inc.
2017-07-05Z-2648-2017Class IIELEOS LIMB SALVAGE SYSTEM SEGMENTAL STEMOnkos Surgical, Inc.
2017-07-05Z-2649-2017Class IIIThe Pointe Scientific CK-MB Isoenzyme Control Pointe Scientific CK-MB…Medtest Holdings, Inc.
2017-07-05Z-2650-2017Class IIIPointe Scientific Liquid Creatine Kinase Reagent Set Device is a kit…Medtest Holdings, Inc.
2017-07-05Z-2651-2017Class IIDRX-Revolution Mobile X-Ray SystemCarestream Health Inc
2017-07-05Z-2652-2017Class IIIMPAX Cardiovascular The IMPAX CV Reporting module consists of a…AGFA Healthcare Corp.
2017-07-05Z-2653-2017Class IISHIMADZU Ceiling Type X-ray Tube Support CH-200/CH-200M Catalog…Shimadzu Medical Systems Usa Com
2017-07-05Z-2654-2017Class IISHIMADZU RADspeed Pro Catalog Number: RADspeed ProShimadzu Medical Systems Usa Com
2017-07-05Z-2655-2017Class IISHIMADZU FDR Visionary Catalog Number: FDR Visionary Suite Stationary…Shimadzu Medical Systems Usa Com
2017-06-28Z-2224-2017Class IVenture RX CatheterVascular Solutions, Inc.
2017-06-28Z-2592-2017Class IIProteus 235Ion Beam Applications S.A.
2017-06-28Z-2601-2017Class IIMerge OrthoPACS softwareMerge Healthcare, Inc.
2017-06-28Z-2602-2017Class IIMiniMed 620G Insulin Infusion PumpMedtronic Inc.
2017-06-28Z-2603-2017Class IIMiniMed 630G Insulin Infusion PumpMedtronic Inc.
2017-06-28Z-2604-2017Class IIMiniMed 640G Insulin Infusion PumpMedtronic Inc.
2017-06-28Z-2605-2017Class IIMiniMed 670G Insulin Infusion PumpMedtronic Inc.
2017-06-28Z-2606-2017Class IIDimension Troponin 1Siemens Healthcare Diagnostics, Inc.
2017-06-28Z-2607-2017Class IIDimension Vista DigoxinSiemens Healthcare Diagnostics, Inc.
2017-06-28Z-2608-2017Class IIDimension Vista EstradiolSiemens Healthcare Diagnostics, Inc.
2017-06-28Z-2609-2017Class IIDimension Vista FerritinSiemens Healthcare Diagnostics, Inc.
2017-06-28Z-2610-2017Class IIDimension Vista ProlactinSiemens Healthcare Diagnostics, Inc.
2017-06-28Z-2611-2017Class IIDimension Vista Thyroid Stimulating HormoneSiemens Healthcare Diagnostics, Inc.
2017-06-28Z-2612-2017Class IIQuikClot TraumaPadZ-Medica, LLC
2017-06-28Z-2613-2017Class IIARCHITECT SHBG Reagent The ARCHITECT SHBG assay is a chemiluminescent…Abbott Laboratories
2017-06-28Z-2615-2017Class IIDePuy Mitek LATARJET EXPERIENCE-Combo Screw Driver Product Code:…DePuy Mitek, Inc., a Johnson & Johnson Co.
2017-06-28Z-2616-2017Class IIDePuy Mitek LATARJET EXPERIENCE Coracoid Drill Product Code: 288201…DePuy Mitek, Inc., a Johnson & Johnson Co.
2017-06-28Z-2617-2017Class IIDePuy Mitek LATARJET EXPERIENCE Coracoid Top Hat Drill Product Code:…DePuy Mitek, Inc., a Johnson & Johnson Co.
2017-06-28Z-2618-2017Class IIDePuy Mitek LATARJET EXPERIENCE Top Hat Tap Product Code: 288203…DePuy Mitek, Inc., a Johnson & Johnson Co.
2017-06-28Z-2619-2017Class IIDePuy Mitek LATARJET EXPERIENCE Extraction Driver Product Code:…DePuy Mitek, Inc., a Johnson & Johnson Co.
2017-06-28Z-2620-2017Class IIMerge OrthoPACS softwareMerge Healthcare, Inc.
2017-06-28Z-2621-2017Class IIOmega Medical ImagingOmega Medical Imaging, Inc.
2017-06-21Z-2154-2017Class IIPhilips DigitalDiagnost 3Philips Electronics North America Corporation
2017-06-21Z-2181-2017Class IIGE Healthcare Revolution EVO X-ray systemGE Healthcare, LLC
2017-06-21Z-2182-2017Class IIGE Healthcare Optima CT660GE Healthcare, LLC
2017-06-21Z-2183-2017Class IIGE Healthcare LightSpeed VCT X-ray systemGE Healthcare, LLC
2017-06-21Z-2184-2017Class IIGE Healthcare Optima CT580GE Healthcare, LLC
2017-06-21Z-2185-2017Class IIGE Healthcare Optima CT520 X-ray systemGE Healthcare, LLC
2017-06-21Z-2186-2017Class IIGE Healthcare Optima CT540 X-ray systemGE Healthcare, LLC
2017-06-21Z-2187-2017Class IIGE Healthcare lnnova IGS 540 ACT X-ray systemGE Healthcare, LLC
2017-06-21Z-2188-2017Class IIGE Healthcare BrightSpeed X-ray systemGE Healthcare, LLC
2017-06-21Z-2189-2017Class IIGE Healthcare Lightspeed RT16 X-ray systemGE Healthcare, LLC
2017-06-21Z-2190-2017Class IIGE Healthcare Discovery PET/CT 600GE Healthcare, LLC
2017-06-21Z-2191-2017Class IIGE Healthcare Discovery Ml DR X-ray systemGE Healthcare, LLC
2017-06-21Z-2192-2017Class IIGE Healthcare Discovery IQ X-ray systemGE Healthcare, LLC
2017-06-21Z-2193-2017Class IIGE Healthcare Discovery Ml X-ray systemGE Healthcare, LLC
2017-06-21Z-2194-2017Class IIGE Healthcare Discovery NM/CT 670GE Healthcare, LLC
2017-06-21Z-2195-2017Class IIGE Healthcare Discovery NM/CT 670 CZT X-ray systemGE Healthcare, LLC
2017-06-21Z-2196-2017Class IIGE Healthcare Discovery NM/CT 570c X-ray systemGE Healthcare, LLC
2017-06-21Z-2322-2017Class IIPhilips DuraDiagnost X-ray systems: DuraDiagnostPhilips Electronics North America Corporation
2017-06-21Z-2323-2017Class IIInfant Warmer SystemGE Healthcare, LLC
2017-06-21Z-2324-2017Class IIVideo BronchoscopePentax of America Inc
2017-06-21Z-2325-2017Class IIVideo CytoscopesPentax of America Inc
2017-06-21Z-2326-2017Class IIVideo Naso pharyngo LaryngoscopesPentax of America Inc
2017-06-21Z-2327-2017Class IIArterial Catheterization KitArrow International Inc
2017-06-21Z-2328-2017Class IISingle-Lumen Central Venous Catheterization Kit with Blue FlexTipArrow International Inc
2017-06-21Z-2329-2017Class II1) Introducer Kit with Integral Hemostasis Valve/Side PortArrow International Inc
2017-06-21Z-2330-2017Class II1) Pressure Injectable Multi-Lumen Central Venous Catheterization Kit…Arrow International Inc
2017-06-21Z-2331-2017Class II1) Pressure Injectable ARROWArrow International Inc
2017-06-21Z-2332-2017Class IIMulti-Lumen Central Venous Catheterization Kit with Blue FlexTipArrow International Inc
2017-06-21Z-2333-2017Class II1) ARROWg+ard Blue MAC Two-Lumen Central Venous Access Kit 2)…Arrow International Inc
2017-06-21Z-2334-2017Class II1) ARROWg+ard Blue You-Blend Two-Lumen Hemodialysis Catheterization…Arrow International Inc
2017-06-21Z-2335-2017Class IIArrow MAC Two-Lumen Central Venous Access Kit Introducer Catheter The…Arrow International Inc
2017-06-21Z-2336-2017Class IIArrow Multi-Lumen CVC Kit The Arrow Two-Lumen Central Venous Access…Arrow International Inc
2017-06-21Z-2337-2017Class IIARROWg+ard Blue CVC Kit The ARROWg+ard Blue CVCs are intended to…Arrow International Inc
2017-06-21Z-2338-2017Class IIArrow Pressure Injectable PICC Kit CatheterArrow International Inc
2017-06-21Z-2341-2017Class IIVITEK¿ 2 Gram-Negative identification cardBiomerieux Inc
2017-06-21Z-2342-2017Class IIVITEK 2 Gram-Positive identification cardBiomerieux Inc
2017-06-21Z-2343-2017Class IIVITEK 2 Yeast identification cardBiomerieux Inc
2017-06-21Z-2344-2017Class IIVITEK 2 Bacillus identification cardBiomerieux Inc
2017-06-21Z-2345-2017Class IIVITEK 2 Neisseria-Haemophilus identification cardBiomerieux Inc
2017-06-21Z-2346-2017Class IIVITEK 2 Anaerobic and Corynebacteria identification cardBiomerieux Inc
2017-06-21Z-2347-2017Class IIVITEK 2 Gram Negative Susceptibility cardBiomerieux Inc
2017-06-21Z-2348-2017Class IIVITEK 2 Gram Negative Susceptibility cardBiomerieux Inc
2017-06-21Z-2349-2017Class IIVITEK 2 Gram Negative Susceptibility cardBiomerieux Inc
2017-06-21Z-2350-2017Class IIVITEK¿ 2 Fungal Susceptibility cardBiomerieux Inc
2017-06-21Z-2351-2017Class IIVITEK 2 Gram Negative Susceptibility cardBiomerieux Inc
2017-06-21Z-2352-2017Class IIVITEK 2 Gram Positive Susceptibility cardBiomerieux Inc
2017-06-21Z-2353-2017Class IIVITEK¿ 2 Gram Positive Susceptibility cardBiomerieux Inc
2017-06-21Z-2354-2017Class IIVITEK¿ 2 Gram Positive Susceptibility cardBiomerieux Inc
2017-06-21Z-2355-2017Class IIVITEK¿ 2 Gram Positive Susceptibility cardBiomerieux Inc
2017-06-21Z-2356-2017Class IIVITEK¿ 2 Gram Positive Susceptibility cardBiomerieux Inc
2017-06-21Z-2357-2017Class IIVITEK 2 Gram Negative Susceptibility cardBiomerieux Inc
2017-06-21Z-2358-2017Class IIVITEK¿ 2 Gram Positive Susceptibility cardBiomerieux Inc
2017-06-21Z-2359-2017Class IIVITEK¿ 2 Gram Positive Susceptibility cardBiomerieux Inc
2017-06-21Z-2360-2017Class IIVITEK¿ 2 Gram Positive Susceptibility cardBiomerieux Inc
2017-06-21Z-2361-2017Class IIVITEK¿ 2 Gram Positive Susceptibility cardBiomerieux Inc
2017-06-21Z-2362-2017Class IIVITEK¿ 2 Gram Positive Susceptibility cardBiomerieux Inc
2017-06-21Z-2363-2017Class IIVITEK¿ 2 Gram Positive Susceptibility cardBiomerieux Inc
2017-06-21Z-2364-2017Class IIVITEK¿ 2 Gram Positive Susceptibility cardBiomerieux Inc
2017-06-21Z-2365-2017Class IIVITEK¿ 2 Gram Positive Susceptibility cardBiomerieux Inc
2017-06-21Z-2366-2017Class IIVITEK 2 Gram Negative Susceptibility cardBiomerieux Inc
2017-06-21Z-2367-2017Class IIVITEK¿ 2 Gram Positive Susceptibility cardBiomerieux Inc
2017-06-21Z-2368-2017Class IIVITEK¿ 2 Gram Positive Susceptibility cardBiomerieux Inc
2017-06-21Z-2369-2017Class IIVITEK¿ 2 Gram Positive Susceptibility cardBiomerieux Inc
2017-06-21Z-2370-2017Class IIVITEK¿ 2 Gram Negative Susceptibility cardBiomerieux Inc
2017-06-21Z-2371-2017Class IIVITEK¿ 2 Gram Positive Susceptibility cardBiomerieux Inc
2017-06-21Z-2372-2017Class IIVITEK¿ 2 Gram Streptococcus Susceptibility cardBiomerieux Inc
2017-06-21Z-2373-2017Class IIVITEK¿ 2 Gram Positive Susceptibility cardBiomerieux Inc
2017-06-21Z-2374-2017Class IIVITEK¿ 2 Gram Negative Susceptibility cardBiomerieux Inc
2017-06-21Z-2375-2017Class IIVITEK¿ 2 Gram Positive Susceptibility cardBiomerieux Inc
2017-06-21Z-2376-2017Class IIVITEK¿ 2 Gram Positive Susceptibility cardBiomerieux Inc
2017-06-21Z-2377-2017Class IIVITEK¿ 2 Gram Positive Susceptibility cardBiomerieux Inc
2017-06-21Z-2378-2017Class IIVITEK¿ 2 Gram Fungal Susceptibility cardBiomerieux Inc
2017-06-21Z-2379-2017Class IIVITEK¿ 2 Gram Negative Susceptibility cardBiomerieux Inc
2017-06-21Z-2380-2017Class IIVITEK¿ 2 Gram Negative Susceptibility cardBiomerieux Inc
2017-06-21Z-2381-2017Class IIVITEK¿ 2 Gram Positive Susceptibility cardBiomerieux Inc
2017-06-21Z-2382-2017Class IIVITEK¿ 2 Gram Negative Susceptibility cardBiomerieux Inc
2017-06-21Z-2383-2017Class IIVITEK¿ 2 Gram Negative Susceptibility cardBiomerieux Inc
2017-06-21Z-2384-2017Class IIVITEK¿ 2 Gram Negative Susceptibility cardBiomerieux Inc
2017-06-21Z-2385-2017Class IIVITEK¿ 2 Gram Negative Susceptibility cardBiomerieux Inc

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