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Medical device recalls reported in 2018

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ReportedRecallClassProductFirm
2018-03-21Z-0971-2018Class IIBaxter SIGMA Spectrum Infusion Pump with Master Drug LibraryBaxter Healthcare Corporation
2018-03-21Z-0972-2018Class IIVial2BagDCMedimop Medical Projects Ltd.
2018-03-21Z-0973-2018Class IILCSU 4Laerdal Medical Corporation
2018-03-21Z-0974-2018Class IICMIStryker Corporation
2018-03-21Z-0975-2018Class IIIMRIS ORT100 TableDeerfield Imaging, Inc.
2018-03-21Z-0976-2018Class IIIMRIS T2X TableDeerfield Imaging, Inc.
2018-03-21Z-0977-2018Class IIOneStep CPR CompleteZOLL Medical Corporation
2018-03-21Z-0978-2018Class IIIHeartStart XL+ Defibrillator/Monitor The HeartStart XL+ is intended…Philips Electronics North America Corporation
2018-03-21Z-0979-2018Class IIHumeral Stem 83mmZimmer Biomet, Inc.
2018-03-21Z-0980-2018Class IIHumeral Stem 55mmZimmer Biomet, Inc.
2018-03-21Z-0981-2018Class IINovaKone Daily Wear Soft contactAlden Optical
2018-03-21Z-0982-2018Class IINovaKone Toric Daily Wear Soft contactAlden Optical
2018-03-21Z-0983-2018Class IIAlden Classic 38 Sphere Daily Wear Soft contactAlden Optical
2018-03-21Z-0984-2018Class IIAlden HP49 Sphere Daily Wear Soft contactAlden Optical
2018-03-21Z-0985-2018Class IIAlden HP54 Sphere Daily Wear Soft contactAlden Optical
2018-03-21Z-0986-2018Class IIAlden HP59 Sphere Daily Wear Soft contactAlden Optical
2018-03-21Z-0987-2018Class IIAlden HP49 Toric Daily Wear Soft contactAlden Optical
2018-03-21Z-0988-2018Class IIAlden HP54 Toric Daily Wear Soft contactAlden Optical
2018-03-21Z-0989-2018Class IIAlden Classic 55 Toric Daily Wear Soft contactAlden Optical
2018-03-21Z-0990-2018Class IIAlden HP59 Toric Daily Wear Soft contactAlden Optical
2018-03-21Z-0991-2018Class IIASTERA Multifocal Toric Daily Wear Soft contactAlden Optical
2018-03-21Z-0992-2018Class IIDELTA CER FEM HD 32/0MM T1 Product Usage: For use in hip arthroplastyZimmer Biomet, Inc.
2018-03-21Z-0993-2018Class IIJUGGERKNOT 2Zimmer Biomet, Inc.
2018-03-21Z-0994-2018Class IIMulti-Lumen Central Venous Catheterization Kit with Blue FlexTipArrow International Inc
2018-03-21Z-0995-2018Class IIPressure Injectable Multi- Lumen Central Venous Catheterization Kit…Arrow International Inc
2018-03-21Z-0996-2018Class IIPressure Injectable Multi- Lumen Central Venous Pressure Injectable…Arrow International Inc
2018-03-21Z-0997-2018Class IIPressure Injectable Multi- Lumen Central Venous Catheterization Kit…Arrow International Inc
2018-03-21Z-0998-2018Class IIAGB+ Pressure Injectable Multi- Lumen CVC Kit Product Usage: The…Arrow International Inc
2018-03-21Z-0999-2018Class IIAGB+ Pressure Injectable Quad- Lumen CVC Kit Product Usage: The…Arrow International Inc
2018-03-21Z-1000-2018Class IIARROWg+ard Blue¿ MAC" Two-Lumen Central Venous Access Kit Product…Arrow International Inc
2018-03-21Z-1001-2018Class IIARROWg+ard Blue¿ Large-Bore Multi-Lumen CVC Kit Product Usage: The…Arrow International Inc
2018-03-21Z-1002-2018Class IIARROWg+ard Blue Product Usage: The Arrow¿ CVC is indicated to provide…Arrow International Inc
2018-03-21Z-1003-2018Class IIAGB+ Pressure Injectable Multi- Lumen CVC Kit Product Usage: The…Arrow International Inc
2018-03-21Z-1004-2018Class IIARROWg+ard BLUE PLUS Pressure Injectable Two- Lumen CVC Kit Product…Arrow International Inc
2018-03-21Z-1005-2018Class IIARROWg+ard BLUE PLUS Pressure Injectable Quad- Lumen CVC Kit Product…Arrow International Inc
2018-03-21Z-1006-2018Class IIExacTrac versions 6Brainlab AG
2018-03-21Z-1007-2018Class IIMAHURKAR"* Elite 12 FR x 16cm Acute Dual Lumen Dialysis Catheter with…Medtronic Minimally Invasive Therapies Group
2018-03-21Z-1008-2018Class II36MM COCR MODULAR HD -6MMZimmer Biomet, Inc.
2018-03-21Z-1009-2018Class IIfastenerZimmer Biomet, Inc.
2018-03-21Z-1010-2018Class IINaturaLyte¿ Liquid Acid Concentrate 2Fresenius Medical Care Renal Therapies Group, LLC
2018-03-21Z-1011-2018Class IIVanguard CR Porous Femoral 62Zimmer Biomet, Inc.
2018-03-21Z-1012-2018Class IIThe GLOBAL UNITE Platform Shoulder System is intended for cemented or…DePuy Orthopaedics, Inc.
2018-03-21Z-1013-2018Class IIIT/Pump temperature therapy pumpStryker Medical Division of Stryker Corporation
2018-03-21Z-1014-2018Class IIBIPOLAR METAL SHELL 48 MM OD Use of the MultiPolar Bipolar Cup is…Zimmer Biomet, Inc.
2018-03-21Z-1015-2018Class IICPT 12/14 COCR REVISION SIZE 2 180MM prosthesisZimmer Biomet, Inc.
2018-03-21Z-1016-2018Class IICPT 12/14 COCR SIZE 0 STD prosthesisZimmer Biomet, Inc.
2018-03-21Z-1017-2018Class IICPT 12/14 COCR SIZE 1 EXT prosthesisZimmer Biomet, Inc.
2018-03-21Z-1018-2018Class IICPT 12/14 COCR SIZE 2 EXT prosthesisZimmer Biomet, Inc.
2018-03-21Z-1019-2018Class IICPT 12/14 COCR SIZE 2 STD prosthesisZimmer Biomet, Inc.
2018-03-21Z-1020-2018Class IIVERSYS 10 INCH BEADED FC REV 13Zimmer Biomet, Inc.
2018-03-21Z-1021-2018Class IIVERSYS 10 INCH BEADED FC REV 15Zimmer Biomet, Inc.
2018-03-21Z-1022-2018Class IIVERSYS 6 INCH BEADED FC 12X160MM LM BODY EXT NECK VERSYS BEADED…Zimmer Biomet, Inc.
2018-03-21Z-1023-2018Class IIVERSYS 6 INCH BEADED FC 13X160MM LM BODY EXT NECK & STD NECK…Zimmer Biomet, Inc.
2018-03-21Z-1024-2018Class IIVERSYS 6 INCH BEADED FC 14X160MM STD BODY EXT & STD NECK ProsthesisZimmer Biomet, Inc.
2018-03-21Z-1025-2018Class IIVERSYS 6 INCH BEADED FC 15X160MM STD BODY STD NECK ProsthesisZimmer Biomet, Inc.
2018-03-21Z-1026-2018Class IIVERSYS 6 INCH BEADED FC STEM 12X160MM LM 13X160MM LM 15X160MM LM…Zimmer Biomet, Inc.
2018-03-21Z-1027-2018Class IIVERSYS 7Zimmer Biomet, Inc.
2018-03-21Z-1028-2018Class IIVERSYS 7Zimmer Biomet, Inc.
2018-03-21Z-1029-2018Class IIVERSYS 8 INCH BEADED FC 12X200MM STR STD BODY/NECK 13X200MM STR STD…Zimmer Biomet, Inc.
2018-03-21Z-1030-2018Class IICR POR FEM HATCP SIZE E/L SIZE F/L Knee ProsthesisZimmer Biomet, Inc.
2018-03-21Z-1031-2018Class IICR-FLX POR HATCP FEM C-L MINUS CR-FLX POR HATCP FEM C-R MINUS CR-FLX…Zimmer Biomet, Inc.
2018-03-21Z-1032-2018Class IICR-FLEX POR HATCP FEM C-L CR-FLEX POR HATCP FEM C-R CR-FLEX POR HATCP…Zimmer Biomet, Inc.
2018-03-21Z-1033-2018Class IINP FEM LT SZ0 NATURAL-KNE NP FEM RT SZ0 NATURAL-KNE NP FEM LT SZ2…Zimmer Biomet, Inc.
2018-03-21Z-1034-2018Class IILPS FEM IMPLANT SZ H-R This device is indicated for patients with…Zimmer Biomet, Inc.
2018-03-21Z-1035-2018Class IILPS OPTION FEMORAL C-L LPS OPTION FEMORAL C-R LPS OPTION FEMORAL D-L…Zimmer Biomet, Inc.
2018-03-21Z-1036-2018Class IILPS FEM COMP SZ B-L LPS FEM COMP SZ B-R LPS FEM COMP SZ C-L LPS FEM…Zimmer Biomet, Inc.
2018-03-21Z-1037-2018Class IILCCK FEM IMPLANT SZ C-L LCCK FEM IMPLANT SZ C-R LCCK FEM IMPLANT SZ…Zimmer Biomet, Inc.
2018-03-21Z-1038-2018Class IILPS POROUS FEM IMPLANT SZ G-L LPS PRECOAT FEM IMPLANT SZ G-L This…Zimmer Biomet, Inc.
2018-03-21Z-1039-2018Class IILPS PRECOAT SRF HDN FEM SZ D-L LPS PRECOAT SRF HDN FEM SZ D-R LPS…Zimmer Biomet, Inc.
2018-03-21Z-1040-2018Class IILPS PRECOAT FEM SIZE D-RT LPS PRECOAT FEM SIZE E-RT LPS POROUS FEM…Zimmer Biomet, Inc.
2018-03-21Z-1041-2018Class IICR PRECOAT FEM COMP SIZE BMR CR PRECOAT FEM COMP SIZE C/R CR PRECOAT…Zimmer Biomet, Inc.
2018-03-21Z-1042-2018Class IICR OPTION FEM COMP SIZE C/L CR OPTION FEM COMP SIZE C/R CR OPTION FEM…Zimmer Biomet, Inc.
2018-03-21Z-1043-2018Class IILPS-FLEX OPTION FEMORAL C-L LPS-FLEX OPTION FEMORAL C-L LPS-FLEX…Zimmer Biomet, Inc.
2018-03-21Z-1044-2018Class IILPS-FLEX PRECOAT FEMORAL B-R LPS-FLEX PRECOAT FEMORAL C-L LPS-FLEX…Zimmer Biomet, Inc.
2018-03-21Z-1045-2018Class IINEXGEN LPS-FLEX PRECOAT FEMORAL SIZE E-LT This device is indicated…Zimmer Biomet, Inc.
2018-03-21Z-1046-2018Class IICR-FLEX OPT FEM C-R MINUS CR-FLEX OPT FEM D-L MINUS CR-FLEX OPT FEM…Zimmer Biomet, Inc.
2018-03-21Z-1047-2018Class IICR-FLEX OPT FEM C-L CR-FLEX OPT FEM C-R CR-FLEX OPT FEM D-L CR-FLEX…Zimmer Biomet, Inc.
2018-03-21Z-1048-2018Class IICR-FLEX POR FEM F-L CR-FLEX POR FEM F-R MINUS CR-FLEX POR FEM G-L…Zimmer Biomet, Inc.
2018-03-21Z-1049-2018Class IICR-FLEX PCT FEM C-R MINUS CR-FLEX PCT FEM D-L MINUS CR-FLEX PCT FEM…Zimmer Biomet, Inc.
2018-03-21Z-1050-2018Class IICR-FLEX PCT FEM B-R CR-FLEX PCT FEM C-L CR-FLEX PCT FEM C-R CR-FLEX…Zimmer Biomet, Inc.
2018-03-21Z-1051-2018Class IIPRCT MIS CR MOB PLT SZ 4 L¿ PRCT MIS CR MOB PLT SZ 5 L¿ PRCT MIS CR…Zimmer Biomet, Inc.
2018-03-21Z-1052-2018Class IIPATELLO-FEMORAL JOINT SYSTEM GENDER SOLUTIONS PATELLO-FEMORAL¿…Zimmer Biomet, Inc.
2018-03-21Z-1053-2018Class IIZIMMER PATELLA FEMORAL JOINT¿ OsteoarthritisZimmer Biomet, Inc.
2018-03-21Z-1054-2018Class IIZUK PRC FEM SZB RMED/LLAT¿ ZUK PRC FEM SZC LMED/RLAT¿ ZUK PRC FEM SZC…Zimmer Biomet, Inc.
2018-03-21Z-1055-2018Class IIFEM PRC LT M/RT L SML FEM PRC RT M/LT L SML FEM PRC LT M/RT L SML+…Zimmer Biomet, Inc.
2018-03-21Z-1056-2018Class IILPS-FLEX GSF OPT SZ C-L¿ LPS-FLEX GSF OPT SZ C-R¿ LPS-FLEX GSF OPT SZ…Zimmer Biomet, Inc.
2018-03-21Z-1057-2018Class IINEXGEN GSF POROUS FEMORAL LPS FLEX SIZE FZimmer Biomet, Inc.
2018-03-21Z-1058-2018Class IICR-FLEX GSF PCT SZ C-R MINUS¿ CR-FLEX GSF PCT SZ D-L MINUS¿ CR-FLEX…Zimmer Biomet, Inc.
2018-03-21Z-1059-2018Class IICR-FLEX GSF PRECOAT SZ C-L¿ CR-FLEX GSF PRECOAT SZ C-R¿ CR-FLEX GSF…Zimmer Biomet, Inc.
2018-03-21Z-1060-2018Class IIGENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM GENDER SOLUTIONS FEMALEZimmer Biomet, Inc.
2018-03-21Z-1061-2018Class IIGENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM FEMORAL COMPONENT¿ N-K FLX…Zimmer Biomet, Inc.
2018-03-21Z-1062-2018Class IIZYMUTEST HIA IgGAMHyphen BioMed
2018-03-21Z-1063-2018Class IIZYMUTEST HIA MonoStrip IgGAMHyphen BioMed
2018-03-21Z-1064-2018Class II6Zimmer Biomet, Inc.
2018-03-21Z-1065-2018Class IIACUSON SC2000 Ultrasound System Product Usage: The SC2000 ultrasound…Siemens Medical Solutions USA, Inc.
2018-03-21Z-1066-2018Class IINeoplastine¿ Cl Plus @Diagnostica Stago, Inc.
2018-03-21Z-1067-2018Class IINeoplastine¿ Cl Plus ¿Diagnostica Stago, Inc.
2018-03-21Z-1068-2018Class IISTADiagnostica Stago, Inc.
2018-03-21Z-1069-2018Class IISTADiagnostica Stago, Inc.
2018-03-21Z-1070-2018Class IIRaPET¿ RF Latex Reagent used as a component in the following kits:…Stanbio Laboratory, LP
2018-03-21Z-1071-2018Class IITunneLoc Tibial Fixation Device Product Usage: To provide fixation of…Zimmer Biomet, Inc.
2018-03-21Z-1072-2018Class IITunneLoc Tibial Fixation DeviceZimmer Biomet, Inc.
2018-03-21Z-1073-2018Class IIPORT-A-CATH II PS/TitanSmiths Medical ASD Inc.
2018-03-21Z-1074-2018Class IIPower PORT-A-CATH IISmiths Medical ASD Inc.
2018-03-14Z-0726-2018Class IIThe GC80 Digital X-ray Imaging SystemNeuroLogica Corporation
2018-03-14Z-0835-2018Class IIStrykeFlow 2 SystemStryker Corporation
2018-03-14Z-0836-2018Class IISTRYKER CASSETTE PUMPStryker Corporation
2018-03-14Z-0837-2018Class IISTRYKER WEDGE INTERFERENCE SCREW SYSTEMStryker Corporation
2018-03-14Z-0838-2018Class IIACL DISPOSABLE PACK BONE-TENDON-BONEStryker Corporation
2018-03-14Z-0839-2018Class IIBrilliance Big Bore Radiology CT with 4Philips Medical Systems (Cleveland) Inc
2018-03-14Z-0840-2018Class IIBrilliance Big Bore Oncology CTwith 4Philips Medical Systems (Cleveland) Inc
2018-03-14Z-0841-2018Class IIIQon Spectral CT with 4Philips Medical Systems (Cleveland) Inc
2018-03-14Z-0842-2018Class IIINFX-8000F Fluoroscopic X-Ray SystemsToshiba American Medical Systems Inc
2018-03-14Z-0843-2018Class IIINFX-8000C Fluoroscopic X-Ray SystemsToshiba American Medical Systems Inc
2018-03-14Z-0844-2018Class IIINFX-8000V Fluoroscopic X-Ray SystemsToshiba American Medical Systems Inc
2018-03-14Z-0845-2018Class IIINFX-8000H Fluoroscopic X-Ray SystemsToshiba American Medical Systems Inc
2018-03-14Z-0846-2018Class IIA-Series A3/A5 Anesthesia Delivery SystemMindray DS USA, Inc. dba Mindray North America
2018-03-14Z-0847-2018Class IIA-Series A7 Anesthesia Delivery SystemMindray DS USA, Inc. dba Mindray North America
2018-03-14Z-0848-2018Class IIConcorde Lift Driver Shaft AODePuy Orthopaedics, Inc.
2018-03-14Z-0849-2018Class IIConcorde Lift Torque Limiting HandleDePuy Orthopaedics, Inc.
2018-03-14Z-0850-2018Class IIPhilips Network FirewallPhilips Electronics North America Corporation
2018-03-14Z-0851-2018Class IILASEREDGE KnivesBausch & Lomb Inc Irb
2018-03-14Z-0852-2018Class IILASEREDGE KnivesBausch & Lomb Inc Irb
2018-03-14Z-0853-2018Class IILASEREDGE KnivesBausch & Lomb Inc Irb
2018-03-14Z-0854-2018Class IILASEREDGE KnivesBausch & Lomb Inc Irb
2018-03-14Z-0855-2018Class IILASEREDGE KnivesBausch & Lomb Inc Irb
2018-03-14Z-0856-2018Class IILASEREDGE KnivesBausch & Lomb Inc Irb
2018-03-14Z-0857-2018Class IILASEREDGE KnivesBausch & Lomb Inc Irb
2018-03-14Z-0858-2018Class IILASEREDGE KnivesBausch & Lomb Inc Irb
2018-03-14Z-0859-2018Class IILASEREDGE KnivesBausch & Lomb Inc Irb
2018-03-14Z-0860-2018Class IILASEREDGE KnivesBausch & Lomb Inc Irb
2018-03-14Z-0861-2018Class IILASEREDGE KnivesBausch & Lomb Inc Irb
2018-03-14Z-0862-2018Class IILASEREDGE KnivesBausch & Lomb Inc Irb
2018-03-14Z-0863-2018Class IILASEREDGE KnivesBausch & Lomb Inc Irb
2018-03-14Z-0864-2018Class IILASEREDGE KnivesBausch & Lomb Inc Irb
2018-03-14Z-0865-2018Class IILASEREDGE KnivesBausch & Lomb Inc Irb
2018-03-14Z-0866-2018Class IILASEREDGE KnivesBausch & Lomb Inc Irb
2018-03-14Z-0867-2018Class IILASEREDGE KnivesBausch & Lomb Inc Irb
2018-03-14Z-0868-2018Class IILASEREDGE KnivesBausch & Lomb Inc Irb
2018-03-14Z-0869-2018Class IILASEREDGE KnivesBausch & Lomb Inc Irb
2018-03-14Z-0870-2018Class IILASEREDGE KnivesBausch & Lomb Inc Irb
2018-03-14Z-0871-2018Class IILASEREDGE KnivesBausch & Lomb Inc Irb
2018-03-14Z-0872-2018Class IILASEREDGE KnivesBausch & Lomb Inc Irb
2018-03-14Z-0873-2018Class IILASEREDGE KnivesBausch & Lomb Inc Irb
2018-03-14Z-0874-2018Class IILASEREDGE KnivesBausch & Lomb Inc Irb
2018-03-14Z-0875-2018Class IILASEREDGE KnivesBausch & Lomb Inc Irb
2018-03-14Z-0876-2018Class IILASEREDGE KnivesBausch & Lomb Inc Irb
2018-03-14Z-0877-2018Class IILASEREDGE KnivesBausch & Lomb Inc Irb
2018-03-14Z-0878-2018Class IILASEREDGE KnivesBausch & Lomb Inc Irb
2018-03-14Z-0879-2018Class IILASEREDGE KnivesBausch & Lomb Inc Irb
2018-03-14Z-0880-2018Class IILASEREDGE KnivesBausch & Lomb Inc Irb
2018-03-14Z-0881-2018Class IILASEREDGE KnivesBausch & Lomb Inc Irb
2018-03-14Z-0882-2018Class IILASEREDGE KnivesBausch & Lomb Inc Irb
2018-03-14Z-0883-2018Class IILASEREDGE KnivesBausch & Lomb Inc Irb
2018-03-14Z-0884-2018Class IILASEREDGE KnivesBausch & Lomb Inc Irb
2018-03-14Z-0885-2018Class IILASEREDGE KnivesBausch & Lomb Inc Irb
2018-03-14Z-0886-2018Class IILASEREDGE KnivesBausch & Lomb Inc Irb
2018-03-14Z-0887-2018Class IILASEREDGE KnivesBausch & Lomb Inc Irb
2018-03-14Z-0888-2018Class IILASEREDGE KnivesBausch & Lomb Inc Irb
2018-03-14Z-0889-2018Class IILASEREDGE KnivesBausch & Lomb Inc Irb
2018-03-14Z-0890-2018Class IILASEREDGE KnivesBausch & Lomb Inc Irb
2018-03-14Z-0891-2018Class IILASEREDGE KnivesBausch & Lomb Inc Irb
2018-03-14Z-0892-2018Class IILASEREDGE KnivesBausch & Lomb Inc Irb
2018-03-14Z-0893-2018Class IILASEREDGE KnivesBausch & Lomb Inc Irb
2018-03-14Z-0894-2018Class IILASEREDGE KnivesBausch & Lomb Inc Irb
2018-03-14Z-0895-2018Class IIHemosll ReadiPlasTinInstrumentation Laboratory Co.
2018-03-14Z-0896-2018Class IIMedtronic Synchromed II Model 8637 supplied in 20mL and 40 mL…Medtronic Neuromodulation
2018-03-14Z-0897-2018Class IIAuriga 30 Laser SystemBoston Scientific Corporation
2018-03-14Z-0898-2018Class IIAuriga XL 4007 Laser SystemBoston Scientific Corporation
2018-03-14Z-0899-2018Class IIISilicone Fluted Round Drain 24FrDegania Silicone, Ltd.
2018-03-14Z-0900-2018Class IIBIO CALMedtronic Perfusion Systems
2018-03-14Z-0901-2018Class II2Synthes (USA) Products LLC
2018-03-14Z-0902-2018Class II2Synthes (USA) Products LLC
2018-03-14Z-0903-2018Class II2Synthes (USA) Products LLC
2018-03-14Z-0904-2018Class II3Synthes (USA) Products LLC
2018-03-14Z-0905-2018Class II2Synthes (USA) Products LLC
2018-03-14Z-0906-2018Class II2Synthes (USA) Products LLC
2018-03-14Z-0907-2018Class IILight Clip for Oracle RetractorSynthes (USA) Products LLC
2018-03-14Z-0908-2018Class IIEndo GIA" Radial Reload with Tri-Staple" Technology The Endo GIA…Covidien LLC
2018-03-14Z-0909-2018Class IIcobas 6000 Modular Series systemRoche Diagnostics Corporation
2018-03-14Z-0910-2018Class IIcobas 8000 Modular Analyzer SeriesRoche Diagnostics Corporation
2018-03-14Z-0911-2018Class IIVITROS Chemistry Products DAT Performance Verifier I in vitro…Ortho-Clinical Diagnostics
2018-03-14Z-0912-2018Class IIVITROS Chemistry Products DAT Performance Verifier II in vitro…Ortho-Clinical Diagnostics
2018-03-14Z-0913-2018Class IIVITROS Chemistry Products DAT Performance Verifier III in vitro…Ortho-Clinical Diagnostics
2018-03-14Z-0914-2018Class IIVITROS Chemistry Products DAT Performance Verifier IV in vitro…Ortho-Clinical Diagnostics
2018-03-14Z-0915-2018Class IIVITROS Chemistry Products DAT Performance Verifier V in vitro…Ortho-Clinical Diagnostics
2018-03-14Z-0916-2018Class IIStryker Sustainability Solutions Reprocessed BW Lasso 2515 NAV eco…Stryker Sustainability Solutions
2018-03-14Z-0917-2018Class IIStryker Sustainability Solutions Reprocessed BW Lasso 2515 NAV eco…Stryker Sustainability Solutions
2018-03-14Z-0918-2018Class IIFlexible Shaft hip and anatomical shoulder instrument used for…Zimmer Biomet, Inc.
2018-03-14Z-0919-2018Class IISirus Drill 13mm diameter trauma instrument used for preparation of…Zimmer Biomet, Inc.
2018-03-14Z-0920-2018Class IISignature Ceramic Femoral HeadSignature Orthopedics Pty Limited
2018-03-14Z-0921-2018Class IIARCHITECT c4000 Cuvette SegmentAbbott Laboratories, Inc
2018-03-14Z-0922-2018Class IIARCHITECT c8000 Cuvette SegmentAbbott Laboratories, Inc
2018-03-14Z-0923-2018Class IIARCHITECT c16000 Cuvette SegmentAbbott Laboratories, Inc
2018-03-14Z-0924-2018Class IIWiener Lab CHAGATEST ELISA RECOMBINANTE VWiener Laboratories
2018-03-14Z-0925-2018Class IIQuikClot TraumaPadZ-Medica, LLC
2018-03-14Z-0926-2018Class IIi-STAT DE handheld data processing module for clinical useAbbott Point Of Care Inc.
2018-03-14Z-0927-2018Class IIO-arm¿ O2 interventional fluoroscopic x-ray systemMedtronic Navigation, Inc.-Littleton
2018-03-14Z-0928-2018Class IIO-arm 1000 mobile image-intensified fluoroscopic x-ray systemMedtronic Navigation, Inc.-Littleton
2018-03-14Z-0929-2018Class IIDIASTAT anti-Nuclear antibodyEuro Diagnostica AB

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