BEUDAMED
    17 results · 20ms · Sources: EU EUDAMED, US FDA

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    DICOMPACS DX-R WITH FLAT PANEL

    FDA 510(k)
    FDA Class 2 ·Radiology

    TALOS® IBF

    FDA UDI
    MEDITECH SPINE, LLC·B16741414400·

    TALOS® IBF

    FDA UDI
    MEDITECH SPINE, LLC·B1674141440060·

    KMEDIC

    FDA UDI
    TELEFLEX INCORPORATED·24026704265866·

    LoFric® Primo™

    FDA UDI
    Wellspect AB·07333387043166·Single Use Urinary Catheter LoFric Primo Nelato...

    LoFric® Primo™

    FDA UDI
    Wellspect AB·07392532135545·Single Use Urinary Catheter LoFric Primo Nelato...

    BOSS Instruments

    FDA UDI
    BOSS INSTRUMENTS, LTD., INC.·00888515019409·Schnidt Tonsil Fcps, strong curve, 7"

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776174798·Olsen Hegar Needle Holder delicate serrated t...

    Yellowstone

    FDA UDI
    SUMMIT SPINE LLC·B587L141440120·14mm H x 14mm W x 40mm L XLIF Trial 12 degree L...

    K2M General Instruments

    FDA UDI
    VB Spine LLC·10888857581357·Split Tube Retractor Ø18x120 mm

    OPUS MAGNUM ANCHOR WITH INSERTER

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    GMD UNIVERSAL URINARY INCONTINENCE SLING, MODEL 1012

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    VC10 PUMP, 115V

    FDA Adverse Event
    Malfunction ·GYRUS ACMI, INC.·Product code HHK·January 2, 2025

    OT ULTRA2 METER

    FDA Adverse Event
    Injury ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 3, 2013

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 4, 2014

    M SERIES

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·June 1, 2011

    ProScreen 10 Drug Panel Cassette Test, Item No. CPSP-10PPX; ProScreen 10 Panel Cup, Item No. PSCup-10MMO-300, PSCup-10M, PSCupA-10MO, PSCUp-10AB; ProScreen 10 Panel Cup with Adulterants, Item No. PSCupA-10AM; ProScreen 10 Panel Dip Card, Item No. PSD-10MMO-300, PSD-10MOX, PSD-10M, PSD-10CMO3, PSD-10APO-300; ProScreen 10 Panel Dip Card w/Adult, Item No. PSDA-10MO, PSDA-10MMO-300; ProScreen 11 Panel Dip Card, Item No. PSD-11MT; ProScreen 12 Drug Cup w/Adulteration, Item No. PSCupA-12TBU; ProScreen 12 Panel Cup w/Adult., Item No. PSCupA-12M, PSCupA-12PP; ProScreen 12 Panel Dip Card, Item No. PSD-12BUP ProScreen 5 Panel Dip Card, Item No. PSD-5MB; ProScreen 5 Panel Dip Card w/Adult, Item No. PSDA-5MB-300; ProScreen 6 Panel Cassette w/Adult (AU), Item No. PSPA-6MBAU; ProScreen 6 Panel Cup w/Adult (AU), Item No. PSCupA-6MBAU; ProScreen 6 Panel Dip Card, Item No. PSD-6MBO, PSD-6MTDBO-300, PSD-6MB, PSD-6BUPO; ProScreen 7 Panel Dip Card, Item No. PSD-7MO, PSD-7M; ProScreen 8 Panel Dip Card, Item No. PSD-8P; ProScreen 8 Panel Dip Card w/Adult, Item No. PSDA-8P; ProScreen 9 Panel Dip Card, Item No. PSD-9P; ProScreen CLIA Waived Cup 6 Drugs w/Adul, Item No. PSCupA-6MB-W; ProScreen CLIA Waived Cup with 6 Drugs, Item No. PSCup-6BO-W; ProScreen CLIA Waived Cup with 8 Drug, Item No. PSCup-8P-W; ProScreen Cup, Item No. PSCup-6MB-W, PSCupA-6MB-W, PSCup-6BO-W, PSCup-8P-W, PSCUp-10AB, PSCup-10MMO-300; ProScreen Cup CLIA with 6 Panel Drug, Item No. PSCup-6MB-W; These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of drug strips, including Benzodiazepine (BZO). They are used to obtain a visual, qualitative result and are intended for professional and point of care use. ¿¿¿

    FDA Enforcement
    Class II ·Terminated·Ameditech Inc·November 25, 2015