BEUDAMED
    95 results · 29ms · Sources: EU EUDAMED, US FDA

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    Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

    FDA Pre-Market Approval
    FDA Class 3 ·Atellica IM Total PSA II (tPSAII)

    LAG FASTENER COUPLER

    FDA UDI
    Osteocentric Technologies, Inc.·00810189110496·LAG FASTENER COUPLER

    Powder Free Nitrile Examination Glove 3.5, Blue Color, Non-Sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate

    FDA 510(k)
    FDA Class 1 ·General Hospital

    Widex

    FDA UDI
    Widex A/S·05706069691221·Widex BEYOND B-F2 (Warm beige ) 440, Telecoil, ...

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 28, 2025

    KIT IMPLANTABLE SLIM TIP LEAD, 50CM

    FDA Adverse Event
    Injury ·ABBOTT MEDICAL·Product code PMP·October 27, 2025

    Heart-Valve, Non-Allograft Tissue

    FDA Pre-Market Approval
    FDA Class 3 ·SJM BIOCOR VALVE / SJM BIOCOR SUPRA VALVE

    Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

    FDA Pre-Market Approval
    FDA Class 2 ·ELECSYS ANTI-HCV II IMMUNOASSAY, ELECSYS PRECICONTROL ANTI-HCV

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

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

    MECHANICAL WALKER, ROLLATOR

    FDA Adverse Event
    KENSTONE METAL·Product code ITJ·November 10, 2014

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 8, 2011

    INCEPTA

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 22, 2013

    Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BTSNL

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

    Replacement Heart-Valve

    FDA Pre-Market Approval
    FDA Class 3 ·SJM EPIC VALVE AND SJM EPIC SUPRA VALVE

    Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

    FDA Pre-Market Approval
    FDA Class 2 ·Elecsys ANti-HCV II (100/200 tests)

    Heart-Valve, Non-Allograft Tissue

    FDA Pre-Market Approval
    FDA Class 3 ·BIOCOR AND EPIC VALVE

    Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

    FDA Pre-Market Approval
    FDA Class 2 ·Elecsys Anti-HCV II Test System

    Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

    FDA Pre-Market Approval
    FDA Class 2 ·Elecsys Anti-HCV II

    Heart-Valve, Non-Allograft Tissue

    FDA Pre-Market Approval
    FDA Class 3 ·ST. JUDE MEDICAL BIOCOR, BIOCOR SUPRA, EPIC AND EPIC SUPRA HEART VLAVES

    Heart-Valve, Non-Allograft Tissue

    FDA Pre-Market Approval
    FDA Class 3 ·Biocor, Biocor Supra, Epic, and Epic Supra Valves