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Medical device recalls reported in 2024

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ReportedRecallClassProductFirm
2024-10-23Z-0059-2025Class IIMonarch Inflation Device 30 atm/bar MAP302 Honor Hemostasis Valve…Merit Medical Systems, Inc.
2024-10-23Z-0060-2025Class IIMonarch Inflation Device 30 atm/bar MAP403 MBA Hemostasis Valve Metal…Merit Medical Systems, Inc.
2024-10-23Z-0061-2025Class IIMonarch Inflation Device 30 atm/bar MAP152 AssessPLUS Large Bore…Merit Medical Systems, Inc.
2024-10-23Z-0062-2025Class IIMelrose Wakefield Hospital REF K05T-2159 Injector And SyringeMerit Medical Systems, Inc.
2024-10-23Z-0063-2025Class II1Stryker Corporation
2024-10-23Z-0064-2025Class IIBlue Diamond Digital Inflation DeviceMerit Medical Systems, Inc.
2024-10-23Z-0065-2025Class IIbasixTOUCH Inflation DeviceMerit Medical Systems, Inc.
2024-10-23Z-0066-2025Class IIDiamondTOUCH Digital Inflation DeviceMerit Medical Systems, Inc.
2024-10-23Z-0067-2025Class IIIntelliSystem Inflation DeviceMerit Medical Systems, Inc.
2024-10-23Z-0068-2025Class IIBlueFIRE Inflation DeviceMerit Medical Systems, Inc.
2024-10-23Z-0069-2025Class IIMONARCH Inflation DeviceMerit Medical Systems, Inc.
2024-10-23Z-0070-2025Class IICustom Inflation KitMerit Medical Systems, Inc.
2024-10-23Z-0071-2025Class IIbasixSKY Inflation DeviceMerit Medical Systems, Inc.
2024-10-23Z-0072-2025Class IIbasixTOUCH Inflation DeviceMerit Medical Systems, Inc.
2024-10-23Z-0073-2025Class IIStabiliT TOUCH SyringeMerit Medical Systems, Inc.
2024-10-23Z-0085-2025Class IILeica Biosystems Cryostat Model Number CM1100LEICA BIOSYSTEMS NUSSLOCH GMBH
2024-10-23Z-0086-2025Class IILeica Biosystems Cryostat Model Number CM1510 SLEICA BIOSYSTEMS NUSSLOCH GMBH
2024-10-23Z-0087-2025Class IILeica Biosystems Cryostat Model Number CM1850LEICA BIOSYSTEMS NUSSLOCH GMBH
2024-10-23Z-0088-2025Class IILeica Biosystems Cryostat Model Number CM1900LEICA BIOSYSTEMS NUSSLOCH GMBH
2024-10-23Z-0089-2025Class IILeica Biosystems Cryostat Model Number CM1950LEICA BIOSYSTEMS NUSSLOCH GMBH
2024-10-23Z-0090-2025Class IILeica Biosystems Cryostat Model Number CM3050 SLEICA BIOSYSTEMS NUSSLOCH GMBH
2024-10-23Z-0091-2025Class IICue Health COVID-19 Test Cartridge REF 2900005 Cue COVID-19 Test Cue…CUE HEALTH INC
2024-10-23Z-0093-2025Class IIIBeckman Coulter IRISPEC CA/CB/CC Urine Chemistry ControlsBeckman Coulter, Inc.
2024-10-23Z-0094-2025Class IIThe Access TSHBeckman Coulter, Inc.
2024-10-23Z-0095-2025Class IIBoston Scientific AVVIGO+ Multi-Modality Guidance SystemBoston Scientific Corporation
2024-10-23Z-0096-2025Class IIBoston Scientific AVVIGO+ Multi-Modality Guidance SystemBoston Scientific Corporation
2024-10-23Z-0097-2025Class IIBoston Scientific AVVIGO+ Multi-Modality Guidance SystemBoston Scientific Corporation
2024-10-23Z-0098-2025Class IIBoston Scientific AVVIGO+ Multi-Modality Guidance SystemBoston Scientific Corporation
2024-10-23Z-0099-2025Class IIBoston Scientific AVVIGO+ Multi-Modality Guidance SystemBoston Scientific Corporation
2024-10-23Z-0100-2025Class IIBoston Scientific AVVIGO+ Multi-Modality Guidance SystemBoston Scientific Corporation
2024-10-23Z-0101-2025Class IIBoston Scientific AVVIGO+ Multi-Modality Guidance SystemBoston Scientific Corporation
2024-10-23Z-0102-2025Class IIBoston Scientific AVVIGO+ Multi-Modality Guidance SystemBoston Scientific Corporation
2024-10-23Z-0103-2025Class IIBoston Scientific AVVIGO+ Multi-Modality Guidance SystemBoston Scientific Corporation
2024-10-23Z-0104-2025Class IIBoston Scientific AVVIGO+ Multi-Modality Guidance SystemBoston Scientific Corporation
2024-10-23Z-0105-2025Class IIBoston Scientific AVVIGO+ Multi-Modality Guidance SystemBoston Scientific Corporation
2024-10-23Z-0106-2025Class IIBoston Scientific AVVIGO+ Multi-Modality Guidance SystemBoston Scientific Corporation
2024-10-23Z-0107-2025Class IIBoston Scientific AVVIGO+ Multi-Modality Guidance SystemBoston Scientific Corporation
2024-10-23Z-0108-2025Class IIBoston Scientific AVVIGO+ Multi-Modality Guidance SystemBoston Scientific Corporation
2024-10-23Z-0109-2025Class IIBoston Scientific AVVIGO+ Multi-Modality Guidance SystemBoston Scientific Corporation
2024-10-23Z-0110-2025Class IIBoston Scientific AVVIGO+ Multi-Modality Guidance SystemBoston Scientific Corporation
2024-10-23Z-0111-2025Class IIBoston Scientific AVVIGO+ Multi-Modality Guidance SystemBoston Scientific Corporation
2024-10-23Z-0112-2025Class IIBoston Scientific AVVIGO+ Multi-Modality Guidance SystemBoston Scientific Corporation
2024-10-23Z-0113-2025Class IIBoston Scientific AVVIGO+ Multi-Modality Guidance SystemBoston Scientific Corporation
2024-10-23Z-0114-2025Class IIBoston Scientific AVVIGO+ Multi-Modality Guidance SystemBoston Scientific Corporation
2024-10-23Z-0115-2025Class IIBoston Scientific AVVIGO+ Multi-Modality Guidance SystemBoston Scientific Corporation
2024-10-23Z-0116-2025Class IIBoston Scientific AVVIGO+ Multi-Modality Guidance SystemBoston Scientific Corporation
2024-10-23Z-0117-2025Class IIThe Graft Tube is an optional instrument whichSpineology, Inc.
2024-10-23Z-0118-2025Class IIIMMAGE Immunochemistry Systems IGM Immunoglobulin M Reagent REF…Beckman Coulter Inc.
2024-10-23Z-0119-2025Class IIMEDLINE HEART CABG CDSMEDLINE INDUSTRIES, LP - Northfield
2024-10-23Z-0120-2025Class IIMEDLINE HEART OVERHEAD TABLE PACKMEDLINE INDUSTRIES, LP - Northfield
2024-10-23Z-0121-2025Class IIMEDLINE OPEN HEART PACKMEDLINE INDUSTRIES, LP - Northfield
2024-10-23Z-0122-2025Class IIMEDLINE OPEN HEARTMEDLINE INDUSTRIES, LP - Northfield
2024-10-23Z-0123-2025Class IIMEDLINE KIT CV I IIMEDLINE INDUSTRIES, LP - Northfield
2024-10-23Z-0124-2025Class IIMEDLINE OPEN HEART NIMC KITMEDLINE INDUSTRIES, LP - Northfield
2024-10-23Z-0125-2025Class IICortera Spinal Fixation System ScrewXTANT Medical Holdings, Inc
2024-10-23Z-0126-2025Class IIChange Healthcare Cardiology HemoCHANGE HEALTHCARE CANADA COMPANY
2024-10-23Z-0127-2025Class IIHorizon Cardiology HemoCHANGE HEALTHCARE CANADA COMPANY
2024-10-23Z-0128-2025Class IIMcKesson Cardiology HemoCHANGE HEALTHCARE CANADA COMPANY
2024-10-23Z-0129-2025Class IIBrand Name: NOVA ORTHO-MED INCNova Ortho-Med Inc
2024-10-23Z-0130-2025Class IIBrand Name: NOVA ORTHO-MED INCNova Ortho-Med Inc
2024-10-23Z-0131-2025Class IIBrand Name: NOVA ORTHO-MED INCNova Ortho-Med Inc
2024-10-23Z-0132-2025Class IIVanta Implantable NeurostimulatorMedtronic Neuromodulation
2024-10-16Z-0005-2025Class IZ-800 Infusion SystemZyno Medical LLC
2024-10-16Z-0020-2025Class IIIntelliVue Patient Monitor MX400/MX450/MX500/MX550 with software…Philips North America Llc
2024-10-16Z-0021-2025Class IIThe Trevo Trak 21 Microcatheter is a single-lumenStryker Neurovascular
2024-10-16Z-0022-2025Class IIFastPack TSH Calibrator KitQualigen Inc
2024-10-16Z-0023-2025Class IITriathlon Universal TS Baseplate Size 2Howmedica Osteonics Corp.
2024-10-16Z-0024-2025Class IIiCast Covered StentAtrium Medical Corporation
2024-10-16Z-0025-2025Class IIBeckman Coulter Dxl 9000 Access Immunoassay AnalyzerBeckman Coulter, Inc.
2024-10-16Z-0026-2025Class IIBD Synapsys Informatics Solution with software versions: 4Becton Dickinson & Co.
2024-10-16Z-0027-2025Class IIAligned Medical Tonsil Tray REF AMS9300A that contains the Cardinal…Windstone Medical Packaging, Inc.
2024-10-16Z-0028-2025Class IIAligned Medical Tonsil ENT Pack REF AMS9977 that contains the…Windstone Medical Packaging, Inc.
2024-10-16Z-0029-2025Class IIAligned Medical Septo Pack REF AMS11480 that contains the Cardinal…Windstone Medical Packaging, Inc.
2024-10-16Z-0030-2025Class IIAligned Medical T and A Pack REF AMS11482 that contains the Cardinal…Windstone Medical Packaging, Inc.
2024-10-16Z-0031-2025Class IIAligned Medical Tonsil Pack REF AMS14809 that contains the Cardinal…Windstone Medical Packaging, Inc.
2024-10-16Z-0032-2025Class IIMEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNITMEDLINE INDUSTRIES, LP - Northfield
2024-10-16Z-0033-2025Class IIMEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNITMEDLINE INDUSTRIES, LP - Northfield
2024-10-16Z-0034-2025Class IIMEDLINE Automatic Digital Blood Pressure MonitorMEDLINE INDUSTRIES, LP - Northfield
2024-10-16Z-0035-2025Class IIPatient Information Center iXPhilips North America
2024-10-16Z-0037-2025Class IIThe EPIONE device v1QUANTUM SURGICAL SAS
2024-10-16Z-0038-2025Class II3M Tegaderm CHG3M Company - Health Care Business
2024-10-16Z-0039-2025Class IIGE Healthcare Centricity Universal Viewer Zero Footprint ClientGE Healthcare
2024-10-16Z-0040-2025Class IIInspire Model 4340 Respiratory Sensing LeadInspire Medical Systems Inc.
2024-10-16Z-0041-2025Class IIInspire Model 4063 Stimulation LeadInspire Medical Systems Inc.
2024-10-16Z-0042-2025Class IINxTAG Respiratory Pathogen PanelLuminex Molecular Diagnostics Inc
2024-10-16Z-0043-2025Class IINxTAG Respiratory Pathogen Panel +SARS-CoV-2Luminex Molecular Diagnostics Inc
2024-10-16Z-0044-2025Class IIMAKO Integrated Cutting SystemHowmedica Osteonics Corp.
2024-10-16Z-0045-2025Class IICheck-Flo Performer Introducer SetCook Incorporated
2024-10-16Z-0050-2025Class IIStealthStation S8 App versions 1Medtronic Navigation, Inc.
2024-10-16Z-0051-2025Class IIMonarch PlatformAURIS HEALTH INC
2024-10-16Z-0052-2025Class IIMonarch PlatformAURIS HEALTH INC
2024-10-16Z-0053-2025Class IIMedline Sterile Laparoscopy PackMEDLINE INDUSTRIES, LP - Northfield
2024-10-16Z-0054-2025Class IIMEDIHONEY Dressing with Active Leptospermum Honey Wound and Burn…Integra LifeSciences Corp.
2024-10-16Z-0055-2025Class IIEnterprise Imaging XERO Viewer- software application used for…Agfa Healthcare NV
2024-10-09Z-0001-2025Class IMiniMed 630G Insulin PumpMedtronic MiniMed, Inc.
2024-10-09Z-0002-2025Class IMiniMed 620G Insulin PumpMedtronic MiniMed, Inc.
2024-10-09Z-0003-2025Class IMiniMed Insulin Pump DeviceMedtronic MiniMed, Inc.
2024-10-09Z-0004-2025Class INeo-Tee T-Piece ResuscitatorMercury Enterprises, Inc. dba Mercury Medical
2024-10-09Z-0006-2025Class IIMiami J Select CollarOssur H / F
2024-10-09Z-0007-2025Class IIIntelliVue G7m Anesthesia Gas ModulePhilips North America
2024-10-09Z-0008-2025Class IIBIOTROL PURIT Clean-It General Purpose Ultrasonic CleanerYoung Dental Manufacturing I, LLC
2024-10-09Z-0009-2025Class IIBD FACSDuet Premium Sample Preparation SystemBecton, Dickinson and Company, BD Bio Sciences
2024-10-09Z-0019-2025Class IITablo ConsoleOutset Medical, Inc.
2024-10-09Z-3207-2024Class IPercussionairePercussionaire Corporation
2024-10-09Z-3208-2024Class IPercussionairePercussionaire Corporation
2024-10-09Z-3303-2024Class IIHealgen Series Reagent strips for Urinalysis are composed of several…Healgen Scientific Llc
2024-10-09Z-3304-2024Class IIADVIA Centaur aTPO AssaySiemens Healthcare Diagnostics, Inc.
2024-10-09Z-3305-2024Class IIAtellica IM aTPO AssaySiemens Healthcare Diagnostics, Inc.
2024-10-09Z-3306-2024Class IIDVOT SARS-CoV-2 ANTIGEN TEST KITFENG CHUN YUAN MEDICAL EQUIPMENT (SHENZHEN)CO.,LTD
2024-10-09Z-3307-2024Class IIDVOT SARS-Cov-2 &Influenza A+B Antigen Combo Test KitFENG CHUN YUAN MEDICAL EQUIPMENT (SHENZHEN)CO.,LTD
2024-10-09Z-3308-2024Class IIDVOT SARS-CoV-2 & RSV &MP &ADV & FIu A/B Antigen Combo Test KitFENG CHUN YUAN MEDICAL EQUIPMENT (SHENZHEN)CO.,LTD
2024-10-09Z-3309-2024Class IIStryker Tornier Perform Humeral SystemTornier, Inc
2024-10-09Z-3310-2024Class IIBIOFINITY XR TORIC LensesCooperVision, Inc.
2024-10-09Z-3311-2024Class IIBiofinity Toric Multifocal LensesCooperVision, Inc.
2024-10-09Z-3312-2024Class IIDIVA 24 Inch Widescreen LCD Touch DisplayPhilips North America Llc
2024-10-09Z-3313-2024Class IIDAILIES TOTAL1Alcon Research LLC
2024-10-02Z-3080-2024Class IIGE Giraffe WarmerWipro GE Healthcare Private Ltd.
2024-10-02Z-3081-2024Class IIGE Panda iRES WarmerWipro GE Healthcare Private Ltd.
2024-10-02Z-3090-2024Class IparaPAC plus 310 ventilator kit with internal PEEP and CPAPSmiths Medical ASD Inc.
2024-10-02Z-3091-2024Class IparaPAC 300 ventilator kit without internal PEEP and CPAPSmiths Medical ASD Inc.
2024-10-02Z-3134-2024Class ICARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMPDatascope Corp.
2024-10-02Z-3135-2024Class ICARDIOSAVE RESCUE INTRA-AORTIC BALLOON PUMPDatascope Corp.
2024-10-02Z-3136-2024Class ICARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMPDatascope Corp.
2024-10-02Z-3137-2024Class ICARDIOSAVE RESCUE INTRA-AORTIC BALLOON PUMPDatascope Corp.
2024-10-02Z-3153-2024Class IIvenix Infusion SystemFresenius Kabi USA, LLC
2024-10-02Z-3158-2024Class IIThe device is a mobile x-ray system designed to work with Fujifilm's…FUJIFILM Healthcare Americas Corporation
2024-10-02Z-3187-2024Class IICreatine KinaseRoche Diagnostics Operations, Inc.
2024-10-02Z-3188-2024Class IISilver-Plated Copper Sims Uterine SoundCooperSurgical, Inc.
2024-10-02Z-3189-2024Class IIStainless Steel Sims Uterine SoundCooperSurgical, Inc.
2024-10-02Z-3190-2024Class IIPrelude Sheath Introducer 7Merit Medical Systems, Inc.
2024-10-02Z-3191-2024Class IICustom Procedure KitMerit Medical Systems, Inc.
2024-10-02Z-3192-2024Class IIBioPince Ultra Full Core Biopsy Instrument: REF: REF: 360-1080-01Argon Medical Devices, Inc
2024-10-02Z-3193-2024Class IIEvolution Upgrade 3Philips North America Llc
2024-10-02Z-3194-2024Class IIIngenia 1Philips North America Llc
2024-10-02Z-3195-2024Class IIIngenia 3Philips North America Llc
2024-10-02Z-3196-2024Class IIIngenia 3Philips North America Llc
2024-10-02Z-3197-2024Class IIIngenia Ambition SPhilips North America Llc
2024-10-02Z-3198-2024Class IIIngenia Ambition XPhilips North America Llc
2024-10-02Z-3199-2024Class IIIngenia Elition S -For use as a diagnostic device to obtain…Philips North America Llc
2024-10-02Z-3200-2024Class IIIngenia Elition X- For use as a diagnostic device to obtain…Philips North America Llc
2024-10-02Z-3201-2024Class IIMR 5300Philips North America Llc
2024-10-02Z-3202-2024Class IIMR 7700 -For use as a diagnostic device to obtain cross-sectional…Philips North America Llc
2024-10-02Z-3203-2024Class IISmartPath to dStream for 1Philips North America Llc
2024-10-02Z-3204-2024Class IISmartPath to dStream for XR and 3Philips North America Llc
2024-10-02Z-3205-2024Class IISmartPath to Ingenia Elition XPhilips North America Llc
2024-10-02Z-3206-2024Class IIBARD MAGNUM Disposable Core Tissue Biopsy Needle REF: MN1410 MN 1420…Bard Peripheral Vascular Inc
2024-10-02Z-3209-2024Class IIGood Vibrations Ultrasonic Cleaner SolutionMicrocare Medical
2024-10-02Z-3210-2024Class IIAVS Anchor-C Cervical Cage System Instructions For UseStryker Spine
2024-10-02Z-3212-2024Class IIprodisc C SKCentinel Spine, Inc.
2024-10-02Z-3213-2024Class IIprodisc C SKCentinel Spine, Inc.
2024-10-02Z-3214-2024Class IIGE Healthcare Centricty PACSGE Healthcare
2024-10-02Z-3215-2024Class IIACUSON Juniper 1Siemens Medical Solutions USA, Inc.
2024-10-02Z-3216-2024Class IIACUSON Redwood 1Siemens Medical Solutions USA, Inc.
2024-10-02Z-3217-2024Class IIACUSON Maple 1Siemens Medical Solutions USA, Inc.
2024-10-02Z-3218-2024Class IIKarl StorzKarl Storz Endoscopy
2024-10-02Z-3219-2024Class IIKarl StorzKarl Storz Endoscopy
2024-10-02Z-3220-2024Class IIKarl StorzKarl Storz Endoscopy
2024-10-02Z-3221-2024Class IIKarl StorzKarl Storz Endoscopy
2024-10-02Z-3222-2024Class IIKarl StorzKarl Storz Endoscopy
2024-10-02Z-3223-2024Class IIKarl StorzKarl Storz Endoscopy
2024-10-02Z-3224-2024Class IIKarl StorzKarl Storz Endoscopy
2024-10-02Z-3225-2024Class IIKarl StorzKarl Storz Endoscopy
2024-10-02Z-3226-2024Class IIPACEMAKER PACKAmerican Contract Systems, Inc.
2024-10-02Z-3227-2024Class IIEndovascular AAA PackAmerican Contract Systems, Inc.
2024-10-02Z-3228-2024Class IIEndovascular AAA PackAmerican Contract Systems, Inc.
2024-10-02Z-3229-2024Class IIArthroscopy PackAmerican Contract Systems, Inc.
2024-10-02Z-3230-2024Class IIOpen ShoulderAmerican Contract Systems, Inc.
2024-10-02Z-3231-2024Class IIDay Surgery General PackAmerican Contract Systems, Inc.
2024-10-02Z-3232-2024Class IIShoulderAmerican Contract Systems, Inc.
2024-10-02Z-3233-2024Class IIBilateral Tubal Ligation PackAmerican Contract Systems, Inc.
2024-10-02Z-3234-2024Class IIParacentesis ThoracenteAmerican Contract Systems, Inc.
2024-10-02Z-3235-2024Class IIIR Procedure PackAmerican Contract Systems, Inc.
2024-10-02Z-3236-2024Class IINeuro VascularAmerican Contract Systems, Inc.
2024-10-02Z-3237-2024Class IIHand PackAmerican Contract Systems, Inc.
2024-10-02Z-3238-2024Class IIVaginal DeliveryAmerican Contract Systems, Inc.
2024-10-02Z-3239-2024Class IICath Lab PackAmerican Contract Systems, Inc.
2024-10-02Z-3240-2024Class IIEssentia MAJ Laparotomy Std PackAmerican Contract Systems, Inc.
2024-10-02Z-3241-2024Class IIENTAmerican Contract Systems, Inc.
2024-10-02Z-3242-2024Class IINasal Sinus PackAmerican Contract Systems, Inc.
2024-10-02Z-3243-2024Class IICystoAmerican Contract Systems, Inc.
2024-10-02Z-3244-2024Class IIPacemakerAmerican Contract Systems, Inc.
2024-10-02Z-3245-2024Class IILINK Universal HandleWaldemar Link GmbH & Co. KG (Corp. Hq.)
2024-10-02Z-3246-2024Class IIBD Phoenix M50 instrument -Intended for the rapid identificationBecton Dickinson & Co.
2024-10-02Z-3247-2024Class IIBD Phoenix 100-Intended for the rapid identificationBecton Dickinson & Co.
2024-10-02Z-3248-2024Class IISelenia Dimensions/ 3Dimensions-Digital breast tomosynthesis Software…Hologic Inc
2024-10-02Z-3249-2024Class IIIntelliVue Patient Monitor MX400Philips North America
2024-10-02Z-3250-2024Class IIBiodesign Fistula Plug C-FPB-0Cook Biotech, Inc.
2024-10-02Z-3251-2024Class IIBiodesign Fistula Plug C-FPB-0Cook Biotech, Inc.
2024-10-02Z-3252-2024Class IIBiodesign Fistula Plug C-FPS-0Cook Biotech, Inc.
2024-10-02Z-3253-2024Class IIBiodesign Fistula Plug C-FPS-0Cook Biotech, Inc.
2024-10-02Z-3254-2024Class IIBiodesign Fistula Plug C-FPS-0Cook Biotech, Inc.
2024-10-02Z-3255-2024Class IIBiodesign Fistula Plug C-FPS-0Cook Biotech, Inc.
2024-10-02Z-3256-2024Class IIBiodesign Fistula Plug C-FPS-0Cook Biotech, Inc.
2024-10-02Z-3257-2024Class IIBiodesign Fistula Plug C-FPS-0Cook Biotech, Inc.
2024-10-02Z-3258-2024Class IIBiodesign Recto-Vaginal Fistula Plug RVP-0Cook Biotech, Inc.
2024-10-02Z-3259-2024Class IIBiodesign Recto-Vaginal Fistula Plug RVP-0Cook Biotech, Inc.
2024-10-02Z-3260-2024Class IIBiodesign Recto-Vaginal Fistula Plug RVP-0Cook Biotech, Inc.
2024-10-02Z-3261-2024Class IIBiodesign Inguinal Hernia Graft C-IHM-10X15Cook Biotech, Inc.
2024-10-02Z-3262-2024Class IIPT301US Airvo 3 Respiratory Support Device with software version 1Fisher & Paykel Healthcare, Ltd.
2024-10-02Z-3263-2024Class IIIeakin Cohesive sealT.G. Eakin Limited

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