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Medical device recalls reported in 2016

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ReportedRecallClassProductFirm
2016-12-28Z-0381-2017Class IILMA MADomizerTeleflex Medical
2016-12-28Z-0382-2017Class IIFLEXI NOZZLE LONGTeleflex Medical
2016-12-28Z-0383-2017Class IIFLEXI NOZZLE SHORT Product Usage: These products are used for the…Teleflex Medical
2016-12-28Z-0384-2017Class IILMA MADgicTeleflex Medical
2016-12-28Z-0385-2017Class IILMA MADettTeleflex Medical
2016-12-28Z-0386-2017Class IILMA MADdyTeleflex Medical
2016-12-28Z-0771-2017Class IIRUSCHTeleflex Medical
2016-12-28Z-0772-2017Class IIIANGIODYNAMICS Percutaneous Introducer Set under the following labels:…Angiodynamics, Inc.
2016-12-28Z-0773-2017Class IIIANGIODYNAMICS Percutaneous Introducer Set under the following labels:…Angiodynamics, Inc.
2016-12-28Z-0774-2017Class IIIANGIODYNAMICS Percutaneous Introducer Set under the following labels:…Angiodynamics, Inc.
2016-12-28Z-0775-2017Class IIIANGIODYNAMICS Percutaneous Introducer Set under the following labels:…Angiodynamics, Inc.
2016-12-28Z-0776-2017Class IIIANGIODYNAMICS Percutaneous Introducer Set under the following labels:…Angiodynamics, Inc.
2016-12-28Z-0777-2017Class IIANGIODYNAMICS Percutaneous Introducer Set under the following labels:…Angiodynamics, Inc.
2016-12-28Z-0778-2017Class IIIANGIODYNAMICS 4F Stiffened Micro-IntroducerAngiodynamics, Inc.
2016-12-28Z-0779-2017Class IIIDELFIA hFSH kitPerkinElmer Health Sciences, Inc.
2016-12-28Z-0780-2017Class IIPerkinElmer 20ul Clear RoboRack TipPerkinElmer, Inc
2016-12-28Z-0781-2017Class IIAlgovita Spinal Cord Stimulation SystemNuvectra
2016-12-28Z-0782-2017Class IIUltroid Hemorrhoid Management Systems 110/220 VAC and procedures kit…Ultroid Technologies, Inc.
2016-12-28Z-0783-2017Class IIUltroid Mobile Generator/Battery operated unit including the Ultroid…Ultroid Technologies, Inc.
2016-12-28Z-0784-2017Class IIUltroid Procedure Pack including the Ultroid Sterile Disposable ProbesUltroid Technologies, Inc.
2016-12-28Z-0785-2017Class IIUltroid Sterile Disposable Probes sold individuallyUltroid Technologies, Inc.
2016-12-28Z-0786-2017Class IIAbbVie PEG Kit 20 FRAbbVie Inc.
2016-12-28Z-0787-2017Class IIAMS-651Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc.
2016-12-28Z-0789-2017Class IIAcuvance¿2 Safety CatheterSmiths Medical ASD Inc.
2016-12-28Z-0790-2017Class IIOSCOR ADELANTE BREEZEWAY 8F C55¿ S61CM D66CM Catalog # AB081040 Is…Oscor, Inc.
2016-12-28Z-0791-2017Class IIOSCOR ADELANTE BREEZEWAY 8F C70¿ S61CM D66CM Catalog # AB081041 Is…Oscor, Inc.
2016-12-28Z-0792-2017Class IIOSCOR ADELANTE BREEZEWAY 8F C90¿ S61CM D66CM Catalog # AB081042 Is…Oscor, Inc.
2016-12-28Z-0793-2017Class IIOSCOR ADELANTE BREEZEWAY 8F C120¿ S61CM D66CM Catalog # AB081043 Is…Oscor, Inc.
2016-12-28Z-0794-2017Class IIOSCOR ADELANTE BREEZEWAY 8F C55¿ S79CM D84CM Catalog # AB081044 Is…Oscor, Inc.
2016-12-28Z-0795-2017Class IIOSCOR ADELANTE BREEZEWAY 8F C70¿ S79CM D84CM Catalog # AB081045 Is…Oscor, Inc.
2016-12-28Z-0796-2017Class IIOSCOR ADELANTE BREEZEWAY 8F C90¿ S79CM D84CM Catalog # AB081046 Is…Oscor, Inc.
2016-12-28Z-0797-2017Class IIOSCOR ADELANTE BREEZEWAY 8F C120¿ S79CM D84CM Catalog # AB081047 Is…Oscor, Inc.
2016-12-28Z-0798-2017Class IIOSCOR ADELANTE BREEZEWAY 8F STRAIGHT S61CM D66CM Catalog # AB081210…Oscor, Inc.
2016-12-28Z-0799-2017Class IIOSCOR ADELANTE BREEZWAY 8F STRAIGHT S79CM D84CM Catalog # AB081211 Is…Oscor, Inc.
2016-12-28Z-0800-2017Class IIOSCOR ADELANTE BREEZEWAY 10F C55¿ S61CM D66CM Catalog # AB101072 Is…Oscor, Inc.
2016-12-28Z-0801-2017Class IIOSCOR ADELANTE BREEZEWAY 10F C70¿ S61CM D66CM Catalog # AB101073 Is…Oscor, Inc.
2016-12-28Z-0802-2017Class IIOSCOR ADELANTE BREEZEWAY 10F C120¿ S61CM D66CM Catalog # AB101075 Is…Oscor, Inc.
2016-12-28Z-0803-2017Class IIOSCOR ADELANTE BREEZEWAY 10F C55¿ S79CM D84CM Catalog # AB101076 Is…Oscor, Inc.
2016-12-28Z-0804-2017Class IIOSCOR ADELANTE BREEZEWAY 10F C70¿ S79CM D84CM Catalog # AB101077 Is…Oscor, Inc.
2016-12-28Z-0805-2017Class IIOSCOR ADELANTE BREEZEWAY 10F C90¿ S79CM D84CM Catalog # AB101078 Is…Oscor, Inc.
2016-12-28Z-0806-2017Class IIOSCOR ADELANTE BREEZEWAY 10F C120¿ S79CM D84CM Catalog # AB101078 Is…Oscor, Inc.
2016-12-28Z-0807-2017Class IIOSCOR ADELANTE BREEZEWAY 10F STRAIGHT S61CM D66CM Catalog # AB101218…Oscor, Inc.
2016-12-28Z-0808-2017Class IIOSCOR ADELANTE BREEZWAY 10F STRAIGHT S79CM D84CM Catalog # AB101219…Oscor, Inc.
2016-12-28Z-0809-2017Class IIOSCOR ADELANTE BREEZEWAY 10F STRAIGHT S61CM D66CM Catalog # AB10218…Oscor, Inc.
2016-12-28Z-0810-2017Class IIOSCOR BREEZEWAY 10F S60Oscor, Inc.
2016-12-28Z-0811-2017Class IIMEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C55¿ S61CM D66CM…Oscor, Inc.
2016-12-28Z-0812-2017Class IIMEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C70¿ S61CM D66CM…Oscor, Inc.
2016-12-28Z-0813-2017Class IIMEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C90¿ S61CM D66CM…Oscor, Inc.
2016-12-28Z-0814-2017Class IIMEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C120¿ S61CM D66CM…Oscor, Inc.
2016-12-28Z-0815-2017Class IIMEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C55¿ S79CM D84CM…Oscor, Inc.
2016-12-28Z-0816-2017Class IIMEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C70¿ S79CM D84CM…Oscor, Inc.
2016-12-28Z-0817-2017Class IIMEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C90¿ S79CM D84CM…Oscor, Inc.
2016-12-28Z-0818-2017Class IIMEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C90¿ S61CM D66CM…Oscor, Inc.
2016-12-28Z-0819-2017Class IIMEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C55¿ S61CM D66CM…Oscor, Inc.
2016-12-28Z-0820-2017Class IITibial Component Fixed Hinge Small LongStanmore Implants Worldwide Ltd.
2016-12-28Z-0821-2017Class IITibial Component Metal Cased Small LongStanmore Implants Worldwide Ltd.
2016-12-28Z-0822-2017Class IIFemoral Shaft L=120mmStanmore Implants Worldwide Ltd.
2016-12-28Z-0823-2017Class IIFemoral Integral Shaft & Stem 15x27 HA CoatedStanmore Implants Worldwide Ltd.
2016-12-28Z-0824-2017Class IIDF Coated Integral Shaft & Stem 15x30x38Stanmore Implants Worldwide Ltd.
2016-12-28Z-0825-2017Class IIIngenia MR-ORPhilips Electronics North America Corporation
2016-12-28Z-0826-2017Class IIAffinity Fusion" Oxygenator with Integrated Arterial FilterMedtronic Inc
2016-12-28Z-0827-2017Class IIZeus-P Lumbar Interbody DeviceAmendia, Inc
2016-12-28Z-0828-2017Class IIBIOMET 3i CERTAIN LOW PROFILE 17¿ ABUTMENT 3Biomet 3i, LLC
2016-12-28Z-0829-2017Class IIBIOMET 3i CERTAIN LOW PROFILE 17¿ ABUTMENT 3Biomet 3i, LLC
2016-12-28Z-0830-2017Class IIBIOMET 3i CERTAIN LOW PROFILE 30¿ ABUTMENT 3Biomet 3i, LLC
2016-12-28Z-0831-2017Class IIBIOMET 3i CERTAIN LOW PROFILE 17¿ ABUTMENT 4Biomet 3i, LLC
2016-12-28Z-0832-2017Class IIBIOMET 3i CERTAIN LOW PROFILE 30¿ ABUTMENT 4Biomet 3i, LLC
2016-12-28Z-0833-2017Class IIBIOMET 3i CERTAIN LOW PROFILE 17¿ ABUTMENT 4Biomet 3i, LLC
2016-12-28Z-0834-2017Class IIBIOMET 3i CERTAIN LOW PROFILE 30¿ ABUTMENT 4Biomet 3i, LLC
2016-12-28Z-0835-2017Class IIBIOMET 3i CERTAIN LOW PROFILE ABUTMENT 3Biomet 3i, LLC
2016-12-28Z-0836-2017Class IIBIOMET 3i CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 3Biomet 3i, LLC
2016-12-28Z-0837-2017Class IIBIOMET 3i CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 3Biomet 3i, LLC
2016-12-28Z-0838-2017Class IIBIOMET 3i CERTAIN LOW PROFILE ABUTMENT 4Biomet 3i, LLC
2016-12-28Z-0839-2017Class IIBIOMET 3i CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 4Biomet 3i, LLC
2016-12-28Z-0840-2017Class IIBIOMET 3i CERTAIN LOW PROFILE ABUTMENT 4Biomet 3i, LLC
2016-12-28Z-0841-2017Class IIBIOMET 3i CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 4Biomet 3i, LLC
2016-12-28Z-0842-2017Class IIBIOMET 3i CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 4Biomet 3i, LLC
2016-12-28Z-0843-2017Class IIBIOMET 3i CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 4Biomet 3i, LLC
2016-12-28Z-0844-2017Class IIBIOMET 3i LOW PROFILE 30¿ ABUTMENT 3Biomet 3i, LLC
2016-12-28Z-0845-2017Class IIBIOMET 3i LOW PROFILE 30¿ ABUTMENT 3Biomet 3i, LLC
2016-12-28Z-0846-2017Class IIBIOMET 3i LOW PROFILE 17¿ ABUTMENT 4Biomet 3i, LLC
2016-12-28Z-0847-2017Class IIBIOMET 3i LOW PROFILE 30¿ ABUTMENT 4Biomet 3i, LLC
2016-12-28Z-0848-2017Class IIBIOMET 3i LOW PROFILE 17¿ ABUTMENT 4Biomet 3i, LLC
2016-12-28Z-0849-2017Class IIBIOMET 3i LOW PROFILE ABUTMENT 4Biomet 3i, LLC
2016-12-28Z-0850-2017Class IIBIOMET 3i LOW PROFILE ONE-PIECE ABUTMENT 4Biomet 3i, LLC
2016-12-28Z-0851-2017Class IIBIOMET 3i LOW PROFILE ONE-PIECE ABUTMENT 4Biomet 3i, LLC
2016-12-28Z-0852-2017Class IIBIOMET 3i LOW PROFILE ABUTMENT 4Biomet 3i, LLC
2016-12-28Z-0853-2017Class IIBIOMET 3i LOW PROFILE ONE-PIECE ABUTMENT 4Biomet 3i, LLC
2016-12-28Z-0854-2017Class IIBIOMET 3i LOW PROFILE ONE-PIECE ABUTMENT 4Biomet 3i, LLC
2016-12-28Z-0855-2017Class IIBIOMET 3i LOW PROFILE ABUTMENT HEALING CAP An endosseous dental…Biomet 3i, LLC
2016-12-28Z-0856-2017Class IIBIOMET 3i LOW PROFILE ABUTMENTBiomet 3i, LLC
2016-12-28Z-0857-2017Class IIBIOMET 3i LOW PROFILE ABUTMENTBiomet 3i, LLC
2016-12-28Z-0858-2017Class IIBIOMET 3i LOW PROFILE ABUTMENT NON-HEXED PREFORMANCE TEMPORARY…Biomet 3i, LLC
2016-12-28Z-0859-2017Class IIBIOMET 3i LOW PROFILE ABUTMENT QUICKBRIDGE An endosseous dental…Biomet 3i, LLC
2016-12-28Z-0860-2017Class IIBIOMET 3i LOW PROFILE ABUTMENT HEXED TEMPORARY CYLINDER An endosseous…Biomet 3i, LLC
2016-12-28Z-0861-2017Class IIBIOMET 3i LOW PROFILE ABUTMENT NON-HEXED TEMPORARY CYLINDER An…Biomet 3i, LLC
2016-12-28Z-0862-2017Class IIBIOMET 3i LOW PROFILE ABUTMENTBiomet 3i, LLC
2016-12-28Z-0863-2017Class IIBIOMET 3i LOW PROFILE ABUTMENT TITANIUM RETAINING SCREW An endosseous…Biomet 3i, LLC
2016-12-28Z-0864-2017Class IIIVITROS CRP Slides: 1) VITROS¿ Chemistry Products CRP SlidesOrtho-Clinical Diagnostics
2016-12-28Z-0865-2017Class IICyberKnife Robotic Radiosurgery SystemsAccuray Incorporated
2016-12-28Z-0866-2017Class IIInsufflatorNorthgate Technologies, Inc.
2016-12-28Z-0867-2017Class IISynthes VA Implant Rack for the Compact Distal Radius System…Synthes (USA) Products LLC
2016-12-28Z-0868-2017Class II8450-107-530 3Stryker Instruments Div. of Stryker Corporation
2016-12-28Z-0869-2017Class II8450-107-525 2Stryker Instruments Div. of Stryker Corporation
2016-12-28Z-0870-2017Class II8470-009-030 3Stryker Instruments Div. of Stryker Corporation
2016-12-28Z-0871-2017Class II8470-009-040 4Stryker Instruments Div. of Stryker Corporation
2016-12-28Z-0872-2017Class II8450-010-040 4Stryker Instruments Div. of Stryker Corporation
2016-12-28Z-0873-2017Class II8450-009-030 3Stryker Instruments Div. of Stryker Corporation
2016-12-28Z-0874-2017Class II8450-009-040 4Stryker Instruments Div. of Stryker Corporation
2016-12-28Z-0877-2017Class IIBD SurePathTM Preservative Collection VialsBecton Dickinson & Co.
2016-12-28Z-0878-2017Class IIMerge OrthoCase softwareMerge Healthcare, Inc.
2016-12-28Z-0879-2017Class IIIOrthoPediatrics PediNail Intramedullary Nailing System 4OrthoPediatrics Corp
2016-12-28Z-0880-2017Class IIGAM Kirschner WireStryker Howmedica Osteonics Corp.
2016-12-28Z-0881-2017Class IIK-Wire 1Amendia, Inc
2016-12-28Z-0882-2017Class IIDual Stylet NeedleAmendia, Inc
2016-12-28Z-0883-2017Class IISavannah-T Straight RodAmendia, Inc
2016-12-28Z-0884-2017Class IIIMMULITE/IMMULITE 1000 Systems Prostate-Specific AntigenSiemens Healthcare Diagnostics, Inc.
2016-12-28Z-0885-2017Class IIIMMULITE 2000/IMMULITE 2000 XPi Systems Prostate-Specific AntigenSiemens Healthcare Diagnostics, Inc.
2016-12-28Z-0886-2017Class IIBlack Widow Plate 19mm PlateAmendia, Inc
2016-12-28Z-0887-2017Class IIBlack Widow 6Amendia, Inc
2016-12-28Z-0888-2017Class IIMedi Choice Arm Slings ASL 2103 Small 7Owens & Minor Distribution, Inc.
2016-12-28Z-0889-2017Class IICovidien Clearify Visualization System Item Code: 21-345 Intended to…Medtronic
2016-12-28Z-0890-2017Class IIBest Practices kits containing certain production lots of Clearify…Medtronic
2016-12-28Z-0891-2017Class IIOptimus Fixed AwlAmendia, Inc
2016-12-28Z-0892-2017Class IIev3Medtronic Inc
2016-12-28Z-0893-2017Class IIGammex Non-Latex Sensitive Neoprene Surgical Gloves Ansell LankaAnsell Healthcare Products LLC
2016-12-28Z-0894-2017Class IICARPAL TUNNEL PACKRobert Busse & Co. Inc. d.b.a. Busse Hospital Disposables
2016-12-28Z-0895-2017Class IIBREAST PACKRobert Busse & Co. Inc. d.b.a. Busse Hospital Disposables
2016-12-28Z-0896-2017Class IISET UP PACK Surgical Instrument TrayRobert Busse & Co. Inc. d.b.a. Busse Hospital Disposables
2016-12-28Z-0897-2017Class IIIEnLite Neonatal TREC KitPerkinElmer Health Sciences, Inc.
2016-12-28Z-0898-2017Class IIMucosal Atomization DeviceTeleflex Medical
2016-12-28Z-0899-2017Class IIAQURE System Software Version 2Radiometer America Inc
2016-12-28Z-0900-2017Class IIEquinoxe Reverse Shoulder Fixed Angle Torque Defining Screw KitExactech, Inc.
2016-12-21Z-0728-2017Class IICarry bar which is an accessory to a lift used for patients in…ErgoSafe Products, LLC (DBA) Prism Medical
2016-12-21Z-0729-2017Class IIMerge Cardio softwareMerge Healthcare, Inc.
2016-12-21Z-0730-2017Class IIMerge Cardio softwareMerge Healthcare, Inc.
2016-12-21Z-0731-2017Class IIMOSAIQ Oncology Information System The product is used to manage…Elekta, Inc.
2016-12-21Z-0732-2017Class IILumexGF Health Products, Inc
2016-12-21Z-0733-2017Class IICook Spectrum Minocycline/Rifampin Impregnated Double Lumen Central…Cook Inc.
2016-12-21Z-0734-2017Class IICyberKnife Robotic Radiosurgery System using software version 10Accuray Incorporated
2016-12-21Z-0735-2017Class IIBARD¿ IrrigationC.R. Bard, Inc.
2016-12-21Z-0736-2017Class IIBARD¿ 70cc Piston Syringe with Catheter TipC.R. Bard, Inc.
2016-12-21Z-0737-2017Class IIBARD¿ Piston SyringeC.R. Bard, Inc.
2016-12-21Z-0738-2017Class IIBARDIA¿ 60cc Piston Irrigation SyringeC.R. Bard, Inc.
2016-12-21Z-0739-2017Class IIPerformance-LOAD Ambulance Cot Fastener StretcherStryker Medical Division of Stryker Corporation
2016-12-21Z-0740-2017Class IIBD Spinal Anesthesia Tray The BD Spinal Anesthesia Tray is intended…Becton Dickinson & Company
2016-12-21Z-0741-2017Class IIMcKesson Powder Free Vinyl Exam Gloves Catalog numbers 14-116CYPRESS MEDICAL PRODUCTS
2016-12-21Z-0742-2017Class IISOMATOM Definition AS SystemSiemens Medical Solutions USA, Inc
2016-12-21Z-0743-2017Class IISOMATOM Definition Flash SystemSiemens Medical Solutions USA, Inc
2016-12-21Z-0744-2017Class IISOMATOM Definition Edge SystemSiemens Medical Solutions USA, Inc
2016-12-21Z-0745-2017Class IIBD 23 G xBecton Dickinson & Company
2016-12-21Z-0746-2017Class IIHarmony Insight Diagnostic Monitor Support SystemSteris Corporation
2016-12-21Z-0747-2017Class IIPerkin Elmer RoboRack 25ulPerkinElmer, Inc
2016-12-21Z-0748-2017Class IIellman A CYNOSURE COMPANY Minor Surgery Bipolar CableEllman International, Inc.
2016-12-21Z-0749-2017Class IICellfina Prep PackUlthera Inc
2016-12-21Z-0750-2017Class IILightMix¿ Zika rRT-PCR Test The LightMix¿ Zika rRT-PCR Test is a…Roche Molecular Systems, Inc.
2016-12-21Z-0751-2017Class IIRochester-Pean Hemostatic Forceps 61/4Integra York PA, Inc
2016-12-21Z-0752-2017Class IIMetzenbaum Scissors 7Integra York PA, Inc
2016-12-21Z-0753-2017Class IIIEcolabEcolab Inc
2016-12-21Z-0754-2017Class IIHF Cable WA00014AOlympus Corporation of the Americas
2016-12-21Z-0755-2017Class IIGE HealthcareGE Healthcare, LLC
2016-12-21Z-0756-2017Class IICovidien Precision Specimen Container- 4 ozCovidien LLC
2016-12-21Z-0757-2017Class IIUltrasound Video Bronchoscope The EB-1970UKPentax of America Inc
2016-12-21Z-0758-2017Class IISterling Nitrile Sterile Powder Free Exam GlovesHalyard Health
2016-12-21Z-0759-2017Class IIWeck Facial Closure Systems have application in laparoscopic…Teleflex Medical
2016-12-21Z-0760-2017Class IIINOVO Purefill Oxygen Compressor Model PF1100 Is an oxygen refill…Inovo, Inc
2016-12-21Z-0761-2017Class IIThe LIFEPAK 15 monitor/defibrillator is intended for use by trained…Physio-Control, Inc.
2016-12-21Z-0762-2017Class IIThe Randox Liquid Cardiac Controls Level 1Randox Laboratories
2016-12-21Z-0763-2017Class IICeramax Skin Barrier Cream: NET WT 0Oculus Innovative Sciences, Inc.
2016-12-21Z-0764-2017Class IIWECK Visistat 35WTeleflex Medical
2016-12-21Z-0765-2017Class IIReprocessed Xcel Bladeless TrocarStryker Sustainability Solutions
2016-12-21Z-0766-2017Class IIEmpowr PS Knee System Box Cut Guide The EMPOWER PS Box Cut Guide is…Encore Medical, Lp
2016-12-21Z-0767-2017Class IIIVEA 500A Intended for Med-Surg patient careFirefly Medical, Inc.
2016-12-21Z-0768-2017Class IIMicroScan LabPro Data Management SystemBeckman Coulter Inc.
2016-12-21Z-0769-2017Class IIUpdated Natus neoBLUE blanket LED Phototherapy SystemsNatus Medical Incorporated
2016-12-21Z-0770-2017Class IINatus neoBLUE blanket LED Phototherapy systemNatus Medical Incorporated
2016-12-14Z-0647-2017Class IMulti-Med Single Lumen Catheters sold in Centurion convenience kitsCenturion Medical Products Corporation
2016-12-14Z-0659-2017Class I5000 Series Freedom DriversSynCardia Systems Inc.
2016-12-14Z-0680-2017Class IIOlympus Scientific Solutions Americas CorporationOlympus Scientific Solutions Americas
2016-12-14Z-0692-2017Class IISOMATOM ForceSiemens Medical Solutions USA, Inc
2016-12-14Z-0693-2017Class IIBrilliance 64 728231 Computed Tomography X-ray systems intended to…Philips Medical Systems (Cleveland) Inc
2016-12-14Z-0694-2017Class IIBrilliance 64 728232 Computed Tomography X-ray systems intended to…Philips Medical Systems (Cleveland) Inc
2016-12-14Z-0695-2017Class IIIngenuity Core 728321 Computed Tomography X-ray systems intended to…Philips Medical Systems (Cleveland) Inc
2016-12-14Z-0696-2017Class IIIngenuity Core 128 728323Philips Medical Systems (Cleveland) Inc
2016-12-14Z-0697-2017Class IIIngenuity CT 728326 Computed Tomography X-ray systems intended to…Philips Medical Systems (Cleveland) Inc
2016-12-14Z-0698-2017Class IIElana Surgical KitHUD The Elana Surgical KitHUDElana, Inc.
2016-12-14Z-0699-2017Class IIAequalis Fx2 implant parts and instrument traysTornier, Inc
2016-12-14Z-0700-2017Class IIModel 37751 Recharger Product Usage: The Medtronic 37751 Recharger is…Medtronic Neuromodulation
2016-12-14Z-0701-2017Class II3M Universal Electrosurgical Pad3M Company - Health Care Business
2016-12-14Z-0702-2017Class IIMANOS EXThayer Intellectual Property, Inc.
2016-12-14Z-0703-2017Class IILCS Complete Knee Revision System VVC Insert Product Usage: LCS VVC…DePuy Orthopaedics, Inc.
2016-12-14Z-0704-2017Class IIUltraSeal XT Plus Clear RefillUltradent Products, Inc.
2016-12-14Z-0705-2017Class IIIQon Spectral CT is a Computed Tomography X-Ray System intended to…Philips Medical Systems (Cleveland) Inc
2016-12-14Z-0706-2017Class IIPhilips Spectral CT Applications supports viewing and analysis of…Philips Medical Systems (Cleveland) Inc
2016-12-14Z-0707-2017Class IIMergeMerge Healthcare, Inc.
2016-12-14Z-0708-2017Class IIXcela Power Injectable PICC Maximal Barrier Nursing Kit The Maximal…Angiodynamics Inc. (Navilyst Medical Inc.)
2016-12-14Z-0709-2017Class IIBioFlo PICC with ENDEXO Technology Maximal Barrier Nursing KitAngiodynamics Inc. (Navilyst Medical Inc.)
2016-12-14Z-0710-2017Class IIBioFlo PICC with ENDEXO and PASV Valve Technology Maximal Barrier…Angiodynamics Inc. (Navilyst Medical Inc.)
2016-12-14Z-0711-2017Class IIEmpowr Knee System Product Usage: Non-porous proximal tibial…Encore Medical, Lp
2016-12-14Z-0712-2017Class IITENNIS ELBOW SUPPORTDeRoyal Industries Inc

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