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Medical device recalls reported in 2012

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ReportedRecallClassProductFirm
2012-10-10Z-2473-2012Class II00789502202 VerSys Femoral Head Provisional 22mm +0 00789502203…Zimmer, Inc.
2012-10-10Z-2474-2012Class II00789502601 VerSys Femoral Head Provisional 26mm -3Zimmer, Inc.
2012-10-10Z-2475-2012Class II00789502801 VerSys Femoral Head Provisional 28mm -3Zimmer, Inc.
2012-10-10Z-2476-2012Class II12/14 Neck Taper 00789503201 VerSys Femoral Head Provisional 32mm -3Zimmer, Inc.
2012-10-10Z-2477-2012Class II00789503601 VerSys Femoral Head Provisional 36mm -3Zimmer, Inc.
2012-10-10Z-2478-2012Class II12/14 Neck Taper 00789504001 VerSys Femoral Head Provisional 40mm -3Zimmer, Inc.
2012-10-10Z-2479-2012Class II00780302201 MIS 12/14 Slotted Femoral Head Provisional -2X22…Zimmer, Inc.
2012-10-10Z-2480-2012Class II00780302601 MIS 12/14 Slotted Femoral Head Provisional -3Zimmer, Inc.
2012-10-10Z-2481-2012Class II00780302801 MIS 12/14 Slotted Femoral Head Provisional -3Zimmer, Inc.
2012-10-10Z-2482-2012Class II00780303201 MIS 12/14 Slotted Femoral Head Provisional -3Zimmer, Inc.
2012-10-10Z-2483-2012Class II00780303601 MIS 12/14 Slotted Femoral Head Provisional -3Zimmer, Inc.
2012-10-10Z-2484-2012Class II00780304001 MIS 12/14 Slotted Femoral Head Provisional -3Zimmer, Inc.
2012-10-10Z-2485-2012Class IIOptilock 2Biomet, Inc.
2012-10-10Z-2486-2012Class IIOptilock T15 AO DriverBiomet, Inc.
2012-10-10Z-2487-2012Class IIStryker Orthopaedics Restoration Modular Cone Body Trials Stryker…Stryker Howmedica Osteonics Corp.
2012-10-10Z-2488-2012Class IITabs Professional MonitorStanley Security Solutions, Inc.
2012-10-10Z-2489-2012Class IITabs Professional MonitorStanley Security Solutions, Inc.
2012-10-10Z-2490-2012Class IITabs Professional MonitorStanley Security Solutions, Inc.
2012-10-10Z-2491-2012Class IITabs Professional Voice + MonitorStanley Security Solutions, Inc.
2012-10-10Z-2492-2012Class IITabs Professional Voice + MonitorStanley Security Solutions, Inc.
2012-10-10Z-2493-2012Class IICemented Tibial Drill Product Usage: The cemented tibial drill is…Zimmer, Inc.
2012-10-10Z-2494-2012Class IIPhilips Digital Diagnost with patient carriage Model: 712050 with…Philips Healthcare Inc.
2012-10-03Z-2432-2012Class IICovidien Duet TRS 45 3Covidien LP
2012-10-03Z-2433-2012Class IICovidien Duet TRS 45 3Covidien LP
2012-10-03Z-2434-2012Class IICovidien Duet TRS 45 4Covidien LP
2012-10-03Z-2435-2012Class IICovidien Duet TRS 45 4Covidien LP
2012-10-03Z-2436-2012Class IICovidien Duet TRS 60 3Covidien LP
2012-10-03Z-2437-2012Class IICovidien Duet TRS 60 3Covidien LP
2012-10-03Z-2438-2012Class IICovidien Duet TRS 60 4Covidien LP
2012-10-03Z-2439-2012Class IICovidien Duet TRS 60 4Covidien LP
2012-10-03Z-2440-2012Class IIBP7561 OPTI CCA-TS B-Lac CassetteOPTI Medical Systems, Inc
2012-10-03Z-2441-2012Class IISleek OTW***REF 426-1201X***Inflated Balloon Dia/mm***1Cordis Corporation
2012-10-03Z-2442-2012Class IISleek ***OTW ***Ref ***426-1501X***Inflated Balloon Dia/mm 1Cordis Corporation
2012-10-03Z-2443-2012Class IITerumo Advanced Perfusion System 1 ASSEMBLY FLOW POD Product Usage:…Terumo Cardiovascular Systems Corporation
2012-10-03Z-2444-2012Class IISharePlan 1RAYSEARCH LABORATORIES AB
2012-10-03Z-2445-2012Class IIITrinity BiotechClark Laboratories, Inc. (dba,Trinity Biotech USA)
2012-10-03Z-2446-2012Class IIEmbolectomy CathetersApplied Medical Resources Corp
2012-10-03Z-2447-2012Class IIBiliary CathetersApplied Medical Resources Corp
2012-10-03Z-2448-2012Class IIIrrigation CathetersApplied Medical Resources Corp
2012-10-03Z-2449-2012Class IITerumo Advanced Perfusion System 1 Flow Module indicated for use in…Terumo Cardiovascular Systems Corporation
2012-10-03Z-2450-2012Class IIArmada 35/ Armada 35 LL PTA CathetersAbbott Vascular
2012-10-03Z-2451-2012Class IIComputed Tomography X-Ray SystemsPhilips Medical Systems (Cleveland) Inc
2012-10-03Z-2452-2012Class IIHologic Fluoroscan Mini C-Arm Model with InSight2Hologic, Inc.
2012-10-03Z-2453-2012Class IIHologic Fluoroscan Mini C-Arm Model with InSight- FD Software Version…Hologic, Inc.
2012-10-03Z-2454-2012Class IIProgel Pleural Air Leak SealantNeomend Inc
2012-10-03Z-2455-2012Class II***REF LS7600***Qty 1*** EC REP*** ConMed Linvatec Xenon Light SourceLinvatec Corp. dba ConMed Linvatec
2012-10-03Z-2456-2012Class II***REF LS7700***Qty 1*** EC REP*** ConMed Linvatec Xenon Universal…Linvatec Corp. dba ConMed Linvatec
2012-10-03Z-2457-2012Class IIThe MAYFIELD¿ Horseshoe Gel Pads are used in conjunction with the…Integra Limited
2012-10-03Z-2458-2012Class IIThe MAYFIELD¿ Horseshoe Gel Pads are used in conjunction with the…Integra Limited
2012-10-03Z-2459-2012Class IIBoston ScientificGreatbatch Medical
2012-10-03Z-2460-2012Class IIAlere Triage TOX Drug Screen 9 PanelAlere San Diego, Inc.
2012-10-03Z-2461-2012Class IIInvacare¿ I-Fit" Shower ChairInvacare Corporation
2012-10-03Z-2462-2012Class IIVarian brand Eclipse Treatment Planning SystemVarian Medical Systems, Inc. Oncology Systems
2012-10-03Z-2463-2012Class IIDEXIS Imaging SuiteImaging Sciences International, LLC
2012-10-03Z-2464-2012Class IISiemens Magnetom SkyraSiemens Medical Solutions USA, Inc
2012-10-03Z-2465-2012Class IIPhilips Digital Diagnost-Mobile Detector Holder for Digital DiagnostPhilips Healthcare Inc.
2012-10-03Z-2466-2012Class IIBariAir Therapy System The BariAir Therapy System is a risk…KCI USA, Inc.
2012-10-03Z-2467-2012Class IIKY LIQUIBEADS Vaginal MoisturizerMc-NEIL-PPC, Inc.
2012-10-03Z-2468-2012Class IITSX-301A/2 Aquilion One CT SystemToshiba American Medical Systems Inc
2012-10-03Z-2469-2012Class IICatheter Irrigation Set labeled in part: ***24K Arthroscopy…Linvatec Corp. dba ConMed Linvatec
2012-10-03Z-2470-2012Class IIThis voluntary medical device correction is related to Alcon products…Alcon Research, LTD.
2012-10-03Z-2471-2012Class IIUltraFlow HPC Flow Directed Micro CatheterMicro Therapeutics Inc, Dba Ev3 Neurovascular
2012-10-03Z-2472-2012Class IIMarathon Flow Directed Micro CatheterMicro Therapeutics Inc, Dba Ev3 Neurovascular
2012-09-26Z-2349-2012Class ICMS-4501-R1 Custom HSG Tray containing 2 ozCustom Medical Specialties, Inc.
2012-09-26Z-2350-2012Class ICMS-8457 Hysteroscopic Sterilization Pack containing 4 ozCustom Medical Specialties, Inc.
2012-09-26Z-2351-2012Class ICMS-4316 Custom Vein Tray containing 4 ozCustom Medical Specialties, Inc.
2012-09-26Z-2352-2012Class ICMS-8450-R1 Custom Vein Tray containing 4 ozCustom Medical Specialties, Inc.
2012-09-26Z-2353-2012Class ICMS-2586 Custom Amnio Tray containing 2 ozCustom Medical Specialties, Inc.
2012-09-26Z-2354-2012Class ICMS-8162-R1 Fox Chase Specials Pack containing 2 ozCustom Medical Specialties, Inc.
2012-09-26Z-2355-2012Class ICMS-8325-R2 Abington Radiology Drainage Pack and CMS-8325-R3 Abington…Custom Medical Specialties, Inc.
2012-09-26Z-2356-2012Class ICMS-8495-R5 Custom Vein Tray containing 4 ozCustom Medical Specialties, Inc.
2012-09-26Z-2357-2012Class ICMS-4873 Custom CT Biopsy TrayCustom Medical Specialties, Inc.
2012-09-26Z-2358-2012Class ICMS-4975 HSG Tray containing 4 ozCustom Medical Specialties, Inc.
2012-09-26Z-2359-2012Class ICMS-5284 Custom Myelogram Tray containing 2 ozCustom Medical Specialties, Inc.
2012-09-26Z-2360-2012Class IBR980-9600 Hysteroscopy Sterile Procedure Kit containing 2 ozCustom Medical Specialties, Inc.
2012-09-26Z-2378-2012Class IIThe product affected by this notice is sold under the trade name…RAYSEARCH LABORATORIES AB
2012-09-26Z-2379-2012Class IIHALO Flex Energy Generators Manufactured by B¿RRX MedicalCovidien LLC
2012-09-26Z-2380-2012Class IISpacelabs Ultraview DM3 Monitor Model Number: 91330-NT The Ultraview…Zoe Medical Incorporated
2012-09-26Z-2381-2012Class IIThe 2Integra Life Sci.
2012-09-26Z-2382-2012Class IIUltraview SL 91493 Integrated Module HousingSpacelabs Healthcare, Llc
2012-09-26Z-2383-2012Class IIVarian brand ClinacVarian Medical Systems, Inc. Oncology Systems
2012-09-26Z-2384-2012Class IIPhilips DigitalDiagnost Systems with M Cabinet Model: 712025…Philips Healthcare Inc.
2012-09-26Z-2385-2012Class IISterile Distraction Screws of 3 different sizes: 12mmTedan Surgical Innovations Llc
2012-09-26Z-2386-2012Class IIMX 16-slice CT Scanner SystemPhilips Medical Systems (Cleveland) Inc
2012-09-26Z-2387-2012Class IIInstrumentation Laboratory ACL TOPInstrumentation Laboratory Co.
2012-09-26Z-2388-2012Class IIInstrumentation Laboratory ACL TOP 700 PN 0000280010 ACL TOP is a…Instrumentation Laboratory Co.
2012-09-26Z-2389-2012Class IIInstrumentation Laboratory ACL TOP CTS PN 0000280020 ACL TOP is a…Instrumentation Laboratory Co.
2012-09-26Z-2390-2012Class IIInstrumentation Laboratory ACL TOP 700 LAS PN 0000280030 ACL TOP is a…Instrumentation Laboratory Co.
2012-09-26Z-2391-2012Class IIInstrumentation Laboratory ACL TOP 500 CTS PN 0000280040 ACL TOP is a…Instrumentation Laboratory Co.
2012-09-26Z-2392-2012Class IIInstrumentation Laboratory ACL TOP 700 CTS PN 0000280050 ACL TOP is a…Instrumentation Laboratory Co.
2012-09-26Z-2393-2012Class III0Amsino Medical USA
2012-09-26Z-2394-2012Class III0Amsino Medical USA
2012-09-26Z-2395-2012Class IIEmpty Evacuated Container 250 mL and 1000 mLHospira Inc.
2012-09-26Z-2396-2012Class IIInfinity¿ sampling deviceUS Endoscopy Group Inc
2012-09-26Z-2397-2012Class IIBD FACS 7-color Setup beads BD BiosciencesBD Biosciences, Systems & Reagents
2012-09-26Z-2398-2012Class IIThe Bio-Rad MONOLISA Anti-HBs EIA is for In Vitro Diagnostic Use and…Bio-Rad Laboratories
2012-09-26Z-2399-2012Class IIJUGGERKNOT IN¿GUIDE PUNCHBiomet, Inc.
2012-09-26Z-2400-2012Class IIGuardian II Hemostasis ValveVascular Solutions, Inc.
2012-09-26Z-2401-2012Class IIZoll X Series Defibrillator/Pacemaker/Monitor Product Usage: The…ZOLL Medical Corporation
2012-09-26Z-2402-2012Class IIA mobileSteris Corporation
2012-09-26Z-2403-2012Class IIAmplilinkRoche Molecular Systems, Inc.
2012-09-26Z-2404-2012Class IIIThe Brilliance CT 16 System Product Usage: The Brilliance 16 is a…Philips Medical Systems (Cleveland) Inc
2012-09-26Z-2405-2012Class IIPrecise Digital Accelerator Delivery of radiation to defined target…Elekta, Inc.
2012-09-26Z-2409-2012Class IIIADVIA Centaur Prolactin Assay: ADVIA Centaur Calibrator B Catalog…Siemens Healthcare Diagnostics, Inc
2012-09-26Z-2410-2012Class IIIADVIA Centaur FSH Assay: ADVIA Centaur Calibrator B US: Calibrator B…Siemens Healthcare Diagnostics, Inc
2012-09-26Z-2411-2012Class IIOctopus 101 PerimeterHaag-Streit USA Inc
2012-09-26Z-2412-2012Class IIBard Ventralight ST MeshDavol, Inc., Subs. C. R. Bard, Inc.
2012-09-26Z-2413-2012Class IIBard Ventralight ST MeshDavol, Inc., Subs. C. R. Bard, Inc.
2012-09-26Z-2414-2012Class IIS-Rom¿ Total Hip System Poly Liner Packaging: The insert is placed…DePuy Orthopaedics, Inc.
2012-09-26Z-2415-2012Class IIKimberly-Clark MIC Safety PEG KitKimberly-Clark Corporation
2012-09-26Z-2416-2012Class IIKimberly-Clark MIC PEG KitKimberly-Clark Corporation
2012-09-26Z-2417-2012Class IIVerify¿ Bowie-Dick Test CardSteris Corporation
2012-09-26Z-2418-2012Class IIAsahi KASEIAsahi Kasei Medical Co., Ltd., Okatomi Plant
2012-09-26Z-2419-2012Class IIAsahi KASEIAsahi Kasei Medical Co., Ltd., Okatomi Plant
2012-09-26Z-2420-2012Class IIAsahi KASEIAsahi Kasei Medical Co., Ltd., Okatomi Plant
2012-09-26Z-2421-2012Class IIAsahi KASEIAsahi Kasei Medical Co., Ltd., Okatomi Plant
2012-09-26Z-2422-2012Class IIAsahi KASEIAsahi Kasei Medical Co., Ltd., Okatomi Plant
2012-09-26Z-2423-2012Class IIAsahi KASEIAsahi Kasei Medical Co., Ltd., Okatomi Plant
2012-09-26Z-2424-2012Class IIAsahi KASEIAsahi Kasei Medical Co., Ltd., Okatomi Plant
2012-09-26Z-2425-2012Class IIIULTRA Fabric Reinforced Surgical GownKimberly-Clark Corporation
2012-09-26Z-2426-2012Class IISTERIS 5085 and 5085 SRT Surgical TablesSteris Corporation
2012-09-26Z-2427-2012Class II12/14 TAPER HIGH OFFSET NECK USE WITH SMITH & NEPHEW STEMS AND 12/14…Smith & Nephew Inc
2012-09-26Z-2428-2012Class IIIntegra CRW Precision ArcIntegra LifeSciences Corporation
2012-09-26Z-2429-2012Class IIIntegra HRAIM Head Ring Assembly with Intubation Mounts The CRW…Integra LifeSciences Corporation
2012-09-26Z-2430-2012Class IIIModel 324JL On-Board Suction System Intended use: On-board suction…Impact Instrumentation, Inc.
2012-09-26Z-2431-2012Class IISekisui Spectrolyse PAI-1Sekisui Diagnostics Llc
2012-09-19Z-2255-2012Class IIOptima XR220amx Mobile general purpose radiographic imaging of the…GE Healthcare, LLC
2012-09-19Z-2256-2012Class IIOptima XR200amxGE Healthcare, LLC
2012-09-19Z-2327-2012Class IIBard Foley procedural trays packaged in breather bagsC.R. Bard, Inc., Urological Division
2012-09-19Z-2328-2012Class IICMS-8412-R2 Custom Cysto Pack containing 2 ozCustom Medical Specialties, Inc.
2012-09-19Z-2329-2012Class IICMS-2890 Custom Needle Local Tray containing PVP Prep Pad The PV…Custom Medical Specialties, Inc.
2012-09-19Z-2330-2012Class IICMS-4219-R2 Custom Laser Pack containing 2 oz bottles PVP Prep…Custom Medical Specialties, Inc.
2012-09-19Z-2331-2012Class IICMS-2981-R3 Arthrogram Tray containing 2 ozCustom Medical Specialties, Inc.
2012-09-19Z-2332-2012Class IISunquest Laboratory Sunquest Laboratory is intended for use by…Sunquest Information Systems, Inc.
2012-09-19Z-2333-2012Class IIAesculap S4 Element 4Aesculap Implant Systems LLC
2012-09-19Z-2334-2012Class IISUN|DASH RADIUS 252 tanning systemJK Products & Services, Inc
2012-09-19Z-2335-2012Class IIThe SYSTEM 1E Liquid Sterilant Processing SystemSteris Corporation
2012-09-19Z-2336-2012Class IIIBLOM-SINGER indwelling TEP OccluderHelix Medical LLC
2012-09-19Z-2337-2012Class IIISTERRAD 100S CassetteAdvanced Sterilization Products
2012-09-19Z-2338-2012Class IIISTERRAD NX CassetteAdvanced Sterilization Products
2012-09-19Z-2339-2012Class IITip Cover for 8mm Monopolar Curved ScissorsIntuitive Surgical, Inc.
2012-09-19Z-2340-2012Class IIMultileaf Collimator To be used for single or multiple fractionsElekta, Inc.
2012-09-19Z-2341-2012Class IISiemens Uroskop AccessSiemens Medical Solutions USA, Inc
2012-09-19Z-2342-2012Class IIInterfaces subject to recall: Medtronic NIMMedtronic Xomed, Inc.
2012-09-19Z-2343-2012Class IIInterfaces subject to recall: Medtronic NIMMedtronic Xomed, Inc.
2012-09-19Z-2344-2012Class IIInterfaces subject to recall: Medtronic NIMMedtronic Xomed, Inc.
2012-09-19Z-2345-2012Class IIVolcano brand Intravascular UltrasoundVolcano Corporation
2012-09-19Z-2346-2012Class IISterile Empty Vial and InjectorHospira, Inc.
2012-09-19Z-2347-2012Class IIPhilips HeartStart MRx monitor/defibrillators Models: M3535A and…Philips Healthcare Inc.
2012-09-19Z-2348-2012Class IISafety monitor included with System 8000 Base The Sarns" Modular…Terumo Cardiovascular Systems Corporation
2012-09-19Z-2361-2012Class IIREF 101-05-20***NOVATION MODULAR DRILL BIT LENGTH: 20mmExactech, Inc.
2012-09-19Z-2362-2012Class IIREF 101-05-30***NOVATION MODULAR DRILL BIT LENGTH: 30mmExactech, Inc.
2012-09-19Z-2363-2012Class IIREF 101-05-40***NOVATION MODULAR DRILL BIT LENGTH: 40mmExactech, Inc.
2012-09-19Z-2364-2012Class IIREF 101-45-20***NOVATION MODULAR DRILL BIT LENGTH: 20mmExactech, Inc.
2012-09-19Z-2365-2012Class IIREF 101-45-30***NOVATION MODULAR DRILL BIT LENGTH: 30mmExactech, Inc.
2012-09-19Z-2366-2012Class IIREF 101-45-40***NOVATION MODULAR DRILL BIT LENGTH: 40mmExactech, Inc.
2012-09-19Z-2367-2012Class IISiemens Mobilett Mira mobile x-ray system Product Usage: Mobile x-ray…Siemens Medical Solutions USA, Inc
2012-09-19Z-2368-2012Class IIEnduramesh Corpectomy Spacer System Product Usage: The Enduramesh is…Lucero Medical LLC
2012-09-19Z-2369-2012Class IICARTO 3 V1Biosense Webster, Inc.
2012-09-19Z-2370-2012Class IIOmnilife Science Apex Knee System Modular Tibia AugmentOmni Life Science
2012-09-19Z-2371-2012Class IIOmnilife Science Apex Knee System Modular Tibia AugmentOmni Life Science
2012-09-19Z-2372-2012Class IIOmnilife Science Apex Knee System Modular Tibia AugmentOmni Life Science
2012-09-19Z-2373-2012Class IIOmnilife Science Apex Knee System Modular Tibia AugmentOmni Life Science
2012-09-19Z-2374-2012Class IIOmnilife Science Apex Knee System Modular Tibia AugmentOmni Life Science
2012-09-19Z-2375-2012Class IIOmnilife Science Apex Knee System Modular Tibia AugmentOmni Life Science
2012-09-19Z-2376-2012Class IIGE HealthcareGE Healthcare, LLC
2012-09-19Z-2377-2012Class IICapsule Neuron Docking StationCapsule Tech Inc.
2012-09-12Z-2250-2012Class INewport HT70 and HT70 Plus VentilatorsNewport Medical Instruments Inc
2012-09-12Z-2260-2012Class IV60 VentilatorRespironics California Inc
2012-09-12Z-2305-2012Class IIsyngoSiemens Healthcare Diagnostics, Inc.
2012-09-12Z-2306-2012Class IIOrasure QuickFlu Rapid A+B Test Manufactured for OraSure TechnologiesPrinceton Biomeditech Corp
2012-09-12Z-2307-2012Class IIPoly stat Flu A & B Test Manufactured for Polymedco 510 Furnace Dock…Princeton Biomeditech Corp
2012-09-12Z-2308-2012Class IIStatus Flu A + B Test Manufactured by Princeton Bio Meditech…Princeton Biomeditech Corp
2012-09-12Z-2309-2012Class IIZilver 518 Vascular Self Expanding Stent The Zilver Vascular Stent is…Cook Ireland Ltd.
2012-09-12Z-2310-2012Class IIOPTETRAK LOGIC TIBIAL INSERT POSTERIOR STABILIZED***Match Component…Exactech, Inc.
2012-09-12Z-2311-2012Class IIAcrobat 3000Trumpf Medical Systems, Inc.
2012-09-12Z-2312-2012Class IICapintec Captus 3000 Thyroid Uptake System Nuclear uptake probe…Capintec Inc
2012-09-12Z-2313-2012Class IISiemens ADVIA Centaur Multi-Diluent 1Siemens Healthcare Diagnostics, Inc
2012-09-12Z-2314-2012Class IITxRx Knee 15 Coil 3TQuality Electrodynamics LLC
2012-09-12Z-2315-2012Class IIToshiba Ultra-Short Magnetic Resonance Imaging SystemToshiba American Medical Systems Inc
2012-09-12Z-2316-2012Class IIBD GeneOhm MRSA ACP Assay Catalog #441637Becton Dickinson & Co.
2012-09-12Z-2317-2012Class IIBD GeneOhm MRSA ACP AssayBecton Dickinson & Co.
2012-09-12Z-2318-2012Class IIBD GeneOhm Cdiff AssayBecton Dickinson & Co.
2012-09-12Z-2319-2012Class IIBD GeneOhm Cdiff AssayBecton Dickinson & Co.
2012-09-12Z-2320-2012Class IIBD GeneOhm VanR AssayBecton Dickinson & Co.
2012-09-12Z-2321-2012Class IIAmeriWater MRO Dialysis RO+ SystemAmeriWater Inc
2012-09-12Z-2322-2012Class IISiemens Mobilett MiraSiemens Medical Solutions USA, Inc
2012-09-12Z-2323-2012Class IIIVersaTREK Windows SoftwareTrek Diagnostic Systems
2012-09-12Z-2324-2012Class IIBrand name: RayStationRAYSEARCH LABORATORIES AB
2012-09-12Z-2325-2012Class III100 ft roll of tubing inside a cardboard boxSteris Corporation
2012-09-12Z-2326-2012Class IIPolar DressingBreg Inc, An Orthofix Company
2012-09-05Z-2251-2012Class IOEC IT3000GE OEC Medical Systems, Inc
2012-09-05Z-2253-2012Class ION-Q pump with ONDEMAND bolus buttonI-Flow Corporation
2012-09-05Z-2263-2012Class IICisco brand HealthPresenceCisco Systems Inc
2012-09-05Z-2264-2012Class IIsyngo Imaging XSSiemens Medical Solutions USA, Inc
2012-09-05Z-2265-2012Class IICanon Solid State X-ray ImagerCanon Inc.
2012-09-05Z-2266-2012Class IIToshiba CT systemsToshiba American Medical Systems Inc
2012-09-05Z-2267-2012Class IICaviCideMetrex Research, LLC.
2012-09-05Z-2268-2012Class IIIMini-Infuser Model 150XL Single Speed Infusion PumpBaxter Healthcare Corp.
2012-09-05Z-2269-2012Class IIIMini-Infuser Model 300XL Multispeed Infusion PumpBaxter Healthcare Corp.

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