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Medical device recalls reported in 2024

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ReportedRecallClassProductFirm
2024-11-13Z-0288-2025Class IIIiotaSOFT Plus Drive UnitIotamotion Inc
2024-11-13Z-0289-2025Class IIMedtronic DLP Aortic Root Cannula with Flow-GuardMedtronic Perfusion Systems
2024-11-13Z-0306-2025Class IIDeRoyal C-SECTION TRACEPACKDeRoyal Industries Inc
2024-11-13Z-0307-2025Class IIDeRoyal CHILDREN'S GENERAL TRACEPACKDeRoyal Industries Inc
2024-11-13Z-0308-2025Class IIDeRoyal CHILDREN'S ORTHOPEDIC TRACEPACKDeRoyal Industries Inc
2024-11-13Z-0309-2025Class IIDeRoyal CHILDREN'S LAPTRACEPACKDeRoyal Industries Inc
2024-11-13Z-0311-2025Class IIMEGA 7Datascope Corp.
2024-11-13Z-0313-2025Class IIThe Access Cortisol assay is a paramagnetic particleBeckman Coulter, Inc.
2024-11-13Z-0314-2025Class IIAdult Cap-ONE Biteblock REF YG-227T The cap-ONE Biteblock is intended…Nihon Kohden America Inc
2024-11-13Z-0315-2025Class IIintelliPATH Universal HRP Detection KitBiocare Medical, LLC
2024-11-13Z-0316-2025Class IISONIALVISION G4 is a multi-purpose X-ray R/F systemSHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION
2024-11-13Z-0317-2025Class IIThe FLUOROspeed is intended to be used as a universal diagnostic…SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION
2024-11-13Z-0318-2025Class IIGE Healthcare Centricity Universal Viewer Zero FootprintGE Healthcare
2024-11-13Z-0319-2025Class IICoated VICRYL Polyglactin 910 Suture VIO 36INEthicon, Inc.
2024-11-13Z-0320-2025Class IIHillrom Welch Allyn HScribe Holter SystemBaxter Healthcare Corporation
2024-11-13Z-0321-2025Class IIHillrom Welch Allyn Q-Stress Cardiac Stress Testing SystemBaxter Healthcare Corporation
2024-11-13Z-0322-2025Class IIHillrom Welch Allyn RScribe 12-Lead Electrocardiograph SystemBaxter Healthcare Corporation
2024-11-13Z-0323-2025Class IIHillrom Welch Allyn Vision Express Holter Analysis SystemBaxter Healthcare Corporation
2024-11-13Z-0324-2025Class IIHillrom Welch Allyn Diagnostic Cardiology SuiteBaxter Healthcare Corporation
2024-11-13Z-0325-2025Class IIHillrom Welch Allyn XScribe Cardiac Stress Testing SystemBaxter Healthcare Corporation
2024-11-13Z-0326-2025Class IITandem Intl Bipolar Cocr Shell/UHMWPE LinerSmith & Nephew, Inc.
2024-11-06Z-0092-2025Class IVasoView HemoPro Endoscopic Vessel Harvesting SystemMaquet Cardiovascular, LLC
2024-11-06Z-0140-2025Class IGE Healthcare Giraffe Omnibed Carestation CS1DATEX--OHMEDA, INC.
2024-11-06Z-0141-2025Class IGE Healthcare Giraffe Incubator Carestation CS1DATEX--OHMEDA, INC.
2024-11-06Z-0208-2025Class IPhasitron5 Breathing CircuitPercussionaire Corporation
2024-11-06Z-0222-2025Class ICADD-Solis Li-ion Rechargeable Battery PacksSmiths Medical ASD Inc.
2024-11-06Z-0228-2025Class IIaBaxter Healthcare Corporation
2024-11-06Z-0229-2025Class IIOlympus Endoscopic Flushing PumpOlympus Corporation of the Americas
2024-11-06Z-0230-2025Class IILIFEPAK 15Physio-Control, Inc.
2024-11-06Z-0231-2025Class IIClariTEE Probe- Miniature transesophageal echo ultrasound probe for…ImaCor Inc.
2024-11-06Z-0232-2025Class IIQuest Spectrum 3 Fluorescent Imaging System Model/Catalog Number:…Olympus Corporation of the Americas
2024-11-06Z-0233-2025Class IIAbbott Alinity m HPV AMP KitAbbott Molecular, Inc.
2024-11-06Z-0234-2025Class IIAbbott Alinity m STI AMP KitAbbott Molecular, Inc.
2024-11-06Z-0235-2025Class IIMICR PATIE RND Model/Catalog Number: 801396Integra LifeSciences Corp.
2024-11-06Z-0236-2025Class IISURG PAT XRAY 1/4X1-1/2 Model/Catalog Number: 801397Integra LifeSciences Corp.
2024-11-06Z-0237-2025Class IISURG PAT XRAY 1/4X3 Model/Catalog Number: 801398Integra LifeSciences Corp.
2024-11-06Z-0238-2025Class IISURG PAT XRAY 1/4X1/4 Model/Catalog Number: 801399Integra LifeSciences Corp.
2024-11-06Z-0239-2025Class IISURG PAT XRAY 1/2X1/2 Model/Catalog Number: 801400Integra LifeSciences Corp.
2024-11-06Z-0240-2025Class IISURG PAT XRAY 3/4X3/4 Model/Catalog Number: 801401Integra LifeSciences Corp.
2024-11-06Z-0241-2025Class IISURG PAT XRAY 1/2X1 Model/Catalog Number: 801402Integra LifeSciences Corp.
2024-11-06Z-0242-2025Class IISURG PAT XRAY 1X1 Model/Catalog Number: 801403Integra LifeSciences Corp.
2024-11-06Z-0243-2025Class IISURG PAT XRAY 1/2X1-1/2 Model/Catalog Number: 801404Integra LifeSciences Corp.
2024-11-06Z-0244-2025Class IISURG PAT XRAY 1/2X2 Model/Catalog Number: 801406Integra LifeSciences Corp.
2024-11-06Z-0245-2025Class IISURG PAT XRAY 1/2X3 Model/Catalog Number: 801407Integra LifeSciences Corp.
2024-11-06Z-0246-2025Class IISURG PAT XRAY 1X3 Model/Catalog Number: 801408Integra LifeSciences Corp.
2024-11-06Z-0247-2025Class IISURG PAT XRAY 3X3 Model/Catalog Number: 801409Integra LifeSciences Corp.
2024-11-06Z-0248-2025Class IISURG STRP 1/8X6 Model/Catalog Number: 801449Integra LifeSciences Corp.
2024-11-06Z-0249-2025Class IISURG STRP 1/4X6 Model/Catalog Number: 801450Integra LifeSciences Corp.
2024-11-06Z-0250-2025Class IISURG STRP 1/2X6 Model/Catalog Number: 801451Integra LifeSciences Corp.
2024-11-06Z-0251-2025Class IISURG STRP 3/4X6 Model/Catalog Number: 801452Integra LifeSciences Corp.
2024-11-06Z-0252-2025Class IISURG STRP 1X6-200 Model/Catalog Number: 801453Integra LifeSciences Corp.
2024-11-06Z-0253-2025Class IISURG STRP 1-1/2X6 Model/Catalog Number: 801454Integra LifeSciences Corp.
2024-11-06Z-0254-2025Class IISURG STRP 2X6 Model/Catalog Number: 801455Integra LifeSciences Corp.
2024-11-06Z-0255-2025Class IISURG STRP 3X6 Model/Catalog Number: 801456Integra LifeSciences Corp.
2024-11-06Z-0256-2025Class IISURG STRP 3-1/2X6 Model/Catalog Number:801457Integra LifeSciences Corp.
2024-11-06Z-0257-2025Class IIChameleon PTA Balloon Catheter with Injection Port 5mm x 40mm x 75cmCovidien LP
2024-11-06Z-0258-2025Class III17-OH Progesterone ELISA 96 well kit- An enzyme immunoassay for the…DRG International, Inc.
2024-11-06Z-0259-2025Class IIOsom Ultra hCG Combo Test- IVD immunoassay for the qualitative…Princeton Biomeditech Corp
2024-11-06Z-0260-2025Class IIIProduct Name: Insight Base FlexTrackx Technology Inc
2024-11-06Z-0261-2025Class IIAmbu¿ VivaSight 2 DLT Endobronchial tubeAmbu Inc.
2024-11-06Z-0262-2025Class IIDuraform Dural Graft ImplantIntegra LifeSciences Corp.
2024-11-06Z-0263-2025Class II1) Flex ExtendersWestmed, Inc.
2024-11-06Z-0264-2025Class IIOlympus Electrosurgical GeneratorOlympus Corporation of the Americas
2024-11-06Z-0265-2025Class IIAccess Thyroglobulin Antibody IIBeckman Coulter, Inc.
2024-11-06Z-0266-2025Class IIremel BactiDrop Acridine OrangeRemel, Inc
2024-11-06Z-0267-2025Class IINihon Kohden Adult/Pediatric Forehead Disposable SpO2 SensorNihon Kohden America Inc
2024-11-06Z-0268-2025Class IINihon Kohden Adult Ear Clip SpO2 SensorNihon Kohden America Inc
2024-11-06Z-0269-2025Class IIAMBU / KING LTSDKing Systems Corp. dba Ambu, Inc.
2024-11-06Z-0270-2025Class IIKING LTSDKing Systems Corp. dba Ambu, Inc.
2024-11-06Z-0271-2025Class IIKING LTSDKing Systems Corp. dba Ambu, Inc.
2024-11-06Z-0272-2025Class IIKING LTSDKing Systems Corp. dba Ambu, Inc.
2024-11-06Z-0273-2025Class IIKING LTSDKing Systems Corp. dba Ambu, Inc.
2024-11-06Z-0274-2025Class IIKING LTSDKing Systems Corp. dba Ambu, Inc.
2024-11-06Z-0275-2025Class IIKING LTSDKing Systems Corp. dba Ambu, Inc.
2024-11-06Z-0276-2025Class IIKING LTSDKing Systems Corp. dba Ambu, Inc.
2024-11-06Z-0277-2025Class IIsmith&nephew LEIGON OXINIUM CONSTRAINED NONPOROUS FEMORAL COMPONENTSmith & Nephew Inc
2024-11-06Z-0278-2025Class IIsmith&nephew LEIGON OXINIUM CONSTRAINED NONPOROUS FEMORAL COMPONENTSmith & Nephew Inc
2024-11-06Z-0279-2025Class IIAVOXimeter 1000EAccriva Diagnostics, Inc.
2024-11-06Z-0280-2025Class IIKLS Martin Battery PackPro-Dex Inc
2024-11-06Z-0281-2025Class IIsmith&nephew GENESIS II NONPOROUS POSTERIOR STABILIZED FEMORAL…Smith & Nephew Inc
2024-11-06Z-0282-2025Class IIsmith&nephew LEGION OXINIUM POSTERIOR STABILIZED NONPOROUS FEMORAL…Smith & Nephew Inc
2024-11-06Z-0283-2025Class IIBrand Name: Vial2Bag Advanced¿ Product Name: Vial2Bag Advanced¿ 20mm…West Pharmaceutical Services AZ, Inc.
2024-10-30Z-0010-2025Class IICADD Medication Cassette ReservoirSmiths Medical ASD Inc.
2024-10-30Z-0011-2025Class IICADD Medication Cassette ReservoirSmiths Medical ASD Inc.
2024-10-30Z-0012-2025Class IICADD Medication Cassette ReservoirSmiths Medical ASD Inc.
2024-10-30Z-0013-2025Class IICADD Medication Cassette ReservoirSmiths Medical ASD Inc.
2024-10-30Z-0014-2025Class IICADD Medication Cassette ReservoirSmiths Medical ASD Inc.
2024-10-30Z-0015-2025Class IICADD Medication Cassette ReservoirSmiths Medical ASD Inc.
2024-10-30Z-0016-2025Class IICADD Medication Cassette ReservoirSmiths Medical ASD Inc.
2024-10-30Z-0017-2025Class IIENT RES 100 ML Non-Sterile W CLAMPSmiths Medical ASD Inc.
2024-10-30Z-0018-2025Class IIENT RESSmiths Medical ASD Inc.
2024-10-30Z-0046-2025Class IWelch Allyn Life2000 Ventilation SystemBaxter Healthcare Corporation
2024-10-30Z-0074-2025Class IAespire 7100Datex-Ohmeda, Inc.
2024-10-30Z-0075-2025Class IAespire 100Datex-Ohmeda, Inc.
2024-10-30Z-0076-2025Class IAespire 7900Datex-Ohmeda, Inc.
2024-10-30Z-0077-2025Class IAespire ViewDatex-Ohmeda, Inc.
2024-10-30Z-0078-2025Class IAvanceDatex-Ohmeda, Inc.
2024-10-30Z-0079-2025Class IAmingoDatex-Ohmeda, Inc.
2024-10-30Z-0080-2025Class IAvance CS2 and Avance CS2 ProDatex-Ohmeda, Inc.
2024-10-30Z-0081-2025Class IAisysDatex-Ohmeda, Inc.
2024-10-30Z-0082-2025Class IAisys CS2Datex-Ohmeda, Inc.
2024-10-30Z-0083-2025Class IAisys CS2 with Et ControlDatex-Ohmeda, Inc.
2024-10-30Z-0084-2025Class IAuxiliary Common Gas OutletDatex-Ohmeda, Inc.
2024-10-30Z-0133-2025Class II(1) Centurion Sterile CirClamp, Reorder #200CR; (2) Centurion…MEDLINE INDUSTRIES, LP - Northfield
2024-10-30Z-0134-2025Class IISoltive Premium SuperPulsed LaserOlympus Corporation of the Americas
2024-10-30Z-0135-2025Class IISoltive Pro SuperPulsed Laser Systems-Intended for incisionOlympus Corporation of the Americas
2024-10-30Z-0136-2025Class IIbk3000B-K Medical A/S
2024-10-30Z-0137-2025Class IISynchroMed II Infusion PumpMedtronic Neuromodulation
2024-10-30Z-0138-2025Class IIQuantimetrix Urine Chemistry Control Set Dipper Urinalysis Dipstick…Mckesson Medical-Surgical Inc. Corporate Office
2024-10-30Z-0139-2025Class IITrinias unitySHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION
2024-10-30Z-0142-2025Class IISTERILIZABLE INTERNAL DEFIBRILLATION PADDLES REF LP20 STERILIZABLE…Physio-Control, Inc.
2024-10-30Z-0143-2025Class IIsmiths medical portexSmiths Medical ASD Inc.
2024-10-30Z-0144-2025Class IIsmiths medical portexSmiths Medical ASD Inc.
2024-10-30Z-0145-2025Class IIsmiths medical portexSmiths Medical ASD Inc.
2024-10-30Z-0146-2025Class IIsmiths medical portexSmiths Medical ASD Inc.
2024-10-30Z-0147-2025Class IIsmiths medical portexSmiths Medical ASD Inc.
2024-10-30Z-0148-2025Class IICenturion PEDIATRIC/ADULT TRACHEOSTOMY TMEDLINE INDUSTRIES, LP - Northfield
2024-10-30Z-0149-2025Class IICenturion EP LAB INSTRUMENT KITMEDLINE INDUSTRIES, LP - Northfield
2024-10-30Z-0150-2025Class IICenturion brandMEDLINE INDUSTRIES, LP - Northfield
2024-10-30Z-0151-2025Class IICenturion OB TRAYMEDLINE INDUSTRIES, LP - Northfield
2024-10-30Z-0152-2025Class IIMedline CV ANESTHESIAMEDLINE INDUSTRIES, LP - Northfield
2024-10-30Z-0153-2025Class IIMedline brand medical procedure convenience kitMEDLINE INDUSTRIES, LP - Northfield
2024-10-30Z-0154-2025Class IIMedline brandMEDLINE INDUSTRIES, LP - Northfield
2024-10-30Z-0155-2025Class IIMedline brandMEDLINE INDUSTRIES, LP - Northfield
2024-10-30Z-0156-2025Class IIMedline brandMEDLINE INDUSTRIES, LP - Northfield
2024-10-30Z-0157-2025Class IIMedline brand medical procedure convenience kitsMEDLINE INDUSTRIES, LP - Northfield
2024-10-30Z-0158-2025Class IIMedline brand medical procedure convenience kitsMEDLINE INDUSTRIES, LP - Northfield
2024-10-30Z-0159-2025Class IIMedline DENTAL PACKMEDLINE INDUSTRIES, LP - Northfield
2024-10-30Z-0160-2025Class IIMedline brand medical procedure convenience kitsMEDLINE INDUSTRIES, LP - Northfield
2024-10-30Z-0161-2025Class IIMedline brand medical procedure convenience kitsMEDLINE INDUSTRIES, LP - Northfield
2024-10-30Z-0162-2025Class IIMedline CENTRAL CATHETER INSERTION TRAMEDLINE INDUSTRIES, LP - Northfield
2024-10-30Z-0163-2025Class IIMedline DIALYSIS PACKMEDLINE INDUSTRIES, LP - Northfield
2024-10-30Z-0164-2025Class IIMedline brand medical procedure convenience kitsMEDLINE INDUSTRIES, LP - Northfield
2024-10-30Z-0165-2025Class IIMedline brand medical procedure convenience kitsMEDLINE INDUSTRIES, LP - Northfield
2024-10-30Z-0166-2025Class IIMedline brand medical procedure convenience kitsMEDLINE INDUSTRIES, LP - Northfield
2024-10-30Z-0167-2025Class IIMedline CHEST TUBE INSERTION TRAY ADULMEDLINE INDUSTRIES, LP - Northfield
2024-10-30Z-0168-2025Class IIMedline IV TEAM PICCMEDLINE INDUSTRIES, LP - Northfield
2024-10-30Z-0169-2025Class IIMedline PEDIATRIC DRAPE PKMEDLINE INDUSTRIES, LP - Northfield
2024-10-30Z-0170-2025Class IIMedline TUBAL LIGATION PACKMEDLINE INDUSTRIES, LP - Northfield
2024-10-30Z-0171-2025Class IIMedline brand medical procedure convenience kitsMEDLINE INDUSTRIES, LP - Northfield
2024-10-30Z-0172-2025Class IIMedline AMBULATORY MINI PACKMEDLINE INDUSTRIES, LP - Northfield
2024-10-30Z-0173-2025Class IIMedline brand medical procedure convenience kitsMEDLINE INDUSTRIES, LP - Northfield
2024-10-30Z-0174-2025Class IIMedline brand medical procedure convenience kitsMEDLINE INDUSTRIES, LP - Northfield
2024-10-30Z-0175-2025Class IIMedline brand medical procedure convenience kitsMEDLINE INDUSTRIES, LP - Northfield
2024-10-30Z-0176-2025Class IIMedline brand medical procedure convenience kitsMEDLINE INDUSTRIES, LP - Northfield
2024-10-30Z-0177-2025Class IIMedline brand medical procedure convenience kitsMEDLINE INDUSTRIES, LP - Northfield
2024-10-30Z-0178-2025Class IIMedline brand medical procedure convenience kitsMEDLINE INDUSTRIES, LP - Northfield
2024-10-30Z-0179-2025Class IIMedline brand medical procedure convenience kitsMEDLINE INDUSTRIES, LP - Northfield
2024-10-30Z-0180-2025Class IIMedline EYE PACKMEDLINE INDUSTRIES, LP - Northfield
2024-10-30Z-0181-2025Class IIOlympus Gastrointestinal VideoscopeOlympus Corporation of the Americas
2024-10-30Z-0182-2025Class IImedex TranStar Single OR Set 1/EASmiths Medical ASD, Inc.
2024-10-30Z-0183-2025Class IImedex TranStar Single ICP Set 1/EASmiths Medical ASD, Inc.
2024-10-30Z-0184-2025Class IImedex NICU Monitoring Kit Set 1/EASmiths Medical ASD, Inc.
2024-10-30Z-0185-2025Class IImedex TRANSTAR MONITORING KIT 1/EASmiths Medical ASD, Inc.
2024-10-30Z-0186-2025Class IImedex TranStar Kit w/ Stopcock1/EASmiths Medical ASD, Inc.
2024-10-30Z-0187-2025Class IImedex Arterial Kit 1/EASmiths Medical ASD, Inc.
2024-10-30Z-0188-2025Class IImedex TranStar Disposable Transducer 1/EASmiths Medical ASD, Inc.
2024-10-30Z-0189-2025Class IImedex TranStar Patient Mount Monitoring Kit 10/EASmiths Medical ASD, Inc.
2024-10-30Z-0190-2025Class IImedex TranStar 72inSmiths Medical ASD, Inc.
2024-10-30Z-0191-2025Class IImedex TranStar 60inSmiths Medical ASD, Inc.
2024-10-30Z-0192-2025Class IImedex TranStar 84inSmiths Medical ASD, Inc.
2024-10-30Z-0193-2025Class IImedex TranStar DPT w/Stopcock & 3cc Flush 10/EASmiths Medical ASD, Inc.
2024-10-30Z-0194-2025Class IImedex TranStar DPT w/Stopcock & 30cc Flush 10/EASmiths Medical ASD, Inc.
2024-10-30Z-0195-2025Class IImedex TranStar DPT w/Two Stopcocks 10/EASmiths Medical ASD, Inc.
2024-10-30Z-0196-2025Class IImedex TranStar Neonatal Monitoring Kit 10/EASmiths Medical ASD, Inc.
2024-10-30Z-0197-2025Class IImedex TranStar KIDS KIT 19INSmiths Medical ASD, Inc.
2024-10-30Z-0198-2025Class IImedex TranStar KIDS KIT 31INSmiths Medical ASD, Inc.
2024-10-30Z-0199-2025Class IImedex TranStar KIDS KIT 34INSmiths Medical ASD, Inc.
2024-10-30Z-0200-2025Class IImedex TranStar KIDS KIT 7INCH CLOSED BLOOD SAMPLE KIT with 30cc/hr…Smiths Medical ASD, Inc.
2024-10-30Z-0201-2025Class IImedex TranStar KIDS KIT 10INSmiths Medical ASD, Inc.
2024-10-30Z-0202-2025Class IImedex TranStar Stopcock w/ExtSmiths Medical ASD, Inc.
2024-10-30Z-0203-2025Class IImedex TranStar SINGLE 84IN SET WITH ANTI-SHUNT STOPCOCK 10/EASmiths Medical ASD, Inc.
2024-10-30Z-0204-2025Class IImedex TranStar MONITORING SET W/SAMPLING PORT 10/EASmiths Medical ASD, Inc.
2024-10-30Z-0205-2025Class IIsmiths medical SurgiVet Advisor Tech AccessoriesSmiths Medical ASD, Inc.
2024-10-30Z-0206-2025Class IIMedtronic Percept RC Implantable NeurostimulatorsMedtronic Neuromodulation
2024-10-30Z-0207-2025Class IIDiasol Acid Concentrate REF G100325-10Dex 100Diasol, Inc
2024-10-30Z-0209-2025Class IIPredict+ is a data-drivenBlue Ortho
2024-10-30Z-0210-2025Class IIBaxter Operating table TruSystem 7000 UBaxter Healthcare Corporation
2024-10-30Z-0211-2025Class IIBaxter Operating Table TruSystem 7000Baxter Healthcare Corporation
2024-10-30Z-0212-2025Class IIBaxter Operating Table TruSystem 7000Baxter Healthcare Corporation
2024-10-30Z-0213-2025Class IIBaxter Operating Table TruSystem 7000Baxter Healthcare Corporation
2024-10-30Z-0214-2025Class IIBaxter Operating Table TruSystem 7000 VBaxter Healthcare Corporation
2024-10-30Z-0215-2025Class IIBaxter Operating Table TruSystem 7000Baxter Healthcare Corporation
2024-10-30Z-0216-2025Class IIBaxter Operating Table TruSystem 7000Baxter Healthcare Corporation
2024-10-30Z-0217-2025Class IIBaxter Operating Table TruSystem 7000 U14Baxter Healthcare Corporation
2024-10-30Z-0218-2025Class IIBaxter Operating Table TruSystem 7000 U14Baxter Healthcare Corporation
2024-10-30Z-0219-2025Class IIAD-TECH Spencer Probe Depth ElectrodeAd-Tech Medical Instrument Corporation
2024-10-30Z-0220-2025Class IIAD-TECH Spencer Probe Depth ElectrodeAd-Tech Medical Instrument Corporation
2024-10-30Z-0221-2025Class IIAD-TECH Spencer Probe Depth ElectrodeAd-Tech Medical Instrument Corporation
2024-10-30Z-0223-2025Class IIA1CNow+ Multi-Test HbA1c System consists ofPolymer Technology Systems, Inc. dba PTS Diagnostics, Inc.
2024-10-30Z-0224-2025Class IIQuantum Perfusion Systems for CPBSpectrum Medical Ltd.
2024-10-30Z-0225-2025Class IIEZDilate Wire Guided Balloon- Indicated for use in adult and…Olympus Corporation of the Americas
2024-10-30Z-0226-2025Class IIBoston Scientific myLUX Patient Application for an Apple Mobile deviceBoston Scientific Corporation
2024-10-23Z-0036-2025Class IICook Medical Hemo-7 Hemospray Endoscopic HemostatWilson-Cook Medical Inc.
2024-10-23Z-0047-2025Class IGE Heathcare Giraffe OmniBedDATEX--OHMEDA, INC.
2024-10-23Z-0048-2025Class IGE Heathcare Giraffe OmniBed CarestationDATEX--OHMEDA, INC.
2024-10-23Z-0049-2025Class IKINOVA Jaco assistive robotKinova Inc
2024-10-23Z-0056-2025Class IIEVIS EXERA III Video System Center Model Number CV-190Olympus Corporation of the Americas
2024-10-23Z-0057-2025Class IIMonarch Inflation Device 30 atm/bar REF IN2130 Injector And SyringeMerit Medical Systems, Inc.
2024-10-23Z-0058-2025Class IIMonarch Inflation Device MAP 112 Access-9 Large Bore Hemostasis Value…Merit Medical Systems, Inc.

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