BEUDAMED
    56 results · 19ms · Sources: EU EUDAMED, US FDA

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    Qualitative And Quantitative Hepatitis B Virus Antibody Assays

    FDA Pre-Market Approval
    FDA Class 2 ·ADVIA Centaur Anti-HBe2 (aHBe2) assay

    Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)

    FDA Pre-Market Approval
    FDA Class 2 ·ADVIA Centaur Anti-HBe2 (AHBe2) Assay

    Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)

    FDA Pre-Market Approval
    FDA Class 2 ·Atellica® IM Anti-HBe2 Assay

    Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)

    FDA Pre-Market Approval
    FDA Class 2 ·Atellica IM Anti-HBe2 (aHBe2)

    Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)

    FDA Pre-Market Approval
    FDA Class 2 ·Atellica IM Anti-HBe2 (aHBe2)

    Paradigm

    FDA UDI
    Proprio, Inc.·00850042604205·Paradigm DRF Mini Clamp

    ReLine

    FDA UDI
    Nuvasive, Inc.·00195377047007·RELINE-O Trial, 5mm H Lamina Ang N L-pop

    MicroAire®

    FDA UDI
    Microaire Surgical Instruments LLC·00847399000941·SMALL SAGITTAL SAW BLADE, 5.8mm X 18mm X 0.5mm

    OptumSI Implant System

    FDA UDI
    SI Solutions, LLC·00850057247084·Blunt Dissector

    Small Cannulated Screw Extractor AO

    FDA UDI
    Osteocentric Technologies, Inc.·00810074306263·Small Cannulated Screw Extractor AO

    WANGENSTEEN TISSUE FORCEPS

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896059399·WANGENSTEEN TISSUE FORCEPS TUNGSTEN CARBIDE SER...

    COVIDIEN PREMIUM SURGICLIP III

    FDA Adverse Event
    Malfunction ·COVIDIEN·Product code FZP·February 20, 2025

    Eclipse DermaFlex Cannula

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Automated External Defibrillators (Non-Wearable)

    FDA Pre-Market Approval
    FDA Class 3 ·HeartSync Multifunction Disposable Single-Use AED Defibrillator Pads

    Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

    FDA Pre-Market Approval
    FDA Class 2 ·ABBOTT REALTIME HCV, ABBOTT REALTIME HCV AMPLIFICATION REAGENT KIT, ABBOTT REALTIME HVC CONTROL KIT, ABBOTT REALTIME HCV

    Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BTS

    FDA Enforcement
    Class II ·Ongoing·Covidien, LP·April 10, 2024

    Automated External Defibrillators (Non-Wearable)

    FDA Pre-Market Approval
    FDA Class 3 ·HeartSync Multifunction Disposable Single-Use AED Defibrillator Pads

    Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

    FDA Pre-Market Approval
    FDA Class 2 ·ABBOTT REALTIME HCV ASSAY

    Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

    FDA Pre-Market Approval
    FDA Class 2 ·ABBOTT REALTIME HCV

    Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

    FDA Pre-Market Approval
    FDA Class 2 ·Abbott RealTime HCV Assay