BEUDAMED
    14 results · 23ms · Sources: EU EUDAMED, US FDA

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    Neodent Implant System- CM Drive Implants

    FDA 510(k)
    FDA Class 2 ·Dental

    AGXO

    FDA UDI
    Oticon A/S·05707131285942·H150V2, RITE 312 WL CNB AGXO

    Ophthalmic Speculum

    FDA UDI
    KATENA PRODUCTS, INC.·00841668100066·TEMPORAL SPECULUM CLOSED WIRE

    ESI

    FDA UDI
    FTT MEDICAL, INC.·B3961501820·HIRSCHMAN ANOSCOPE, MEDIUM, 3/4" X 2-3/4". ACMI...

    RZ Medizintechnik GmbH

    FDA UDI
    RZ-Medizintechnik GmbH·04049197525909·Caspar Rongeur downwards angled 2x12mm 1 80mm

    PULSAVAC®

    FDA UDI
    ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.·00889024374966·High Capacity Narrow Intramedullary Tip

    Q.STEPS BIOMETER G/C DUAL MONITORING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    SALVIN DENTAL SPECIALTIES FIXATION SCREW

    FDA 510(k)
    FDA Class 2 ·Dental

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FKX·October 7, 2014

    ARCHITECT C8000 SYSTEM

    FDA Adverse Event
    Malfunction ·ABBOTT MANUFACTURING INC·Product code JJE·July 6, 2011

    PAINSMART IOD

    FDA Adverse Event
    Malfunction ·MOOG DEVICE GROUP·Product code FRN·May 28, 2013

    NovoCut Suture Manager; Ceterix catalog number CTX-001. General and Plastic Surgery: Intended for use in arthroscopic surgery.

    FDA Enforcement
    Class II ·Terminated·Ceterix Orthopedics, Inc.·November 18, 2015

    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

    Exactech Equinoxe REVERSE SHOULDER,46mm Humeral Liner, a) +0mm, Item number 320-46-00, b) +2.5mm, Item Number 320-46-03; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024