BEUDAMED
    16 results · 21ms · Sources: EU EUDAMED, US FDA

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    Ventilation (Tympanostomy) Tubes

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    AGC TRADITION KNEE SYSTEM

    FDA UDI
    Biomet Orthopedics, LLC·00880304240827·

    Oticon

    FDA UDI
    Oticon A/S·05707131284273·H11V2 TI, BTE 13 WL 85 CBE

    Rumex

    FDA UDI
    RUMEX INTERNATIONAL CORP.·00840159905401·Jaymce Anterior Chamber Maintainer, Bulbous Tip...

    Engage Partial Knee System

    FDA UDI
    Engage UNI LLC·B6951510670000·Slap Hammer

    PRUITT F3 OUTLYING AND INLYING CAROTID SHUNT (WITH AND WITHOUT T-PORT)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SURESIGNS VM4, SURESIGNS VM6, SURESIGNS VM8 MODEL: 863063, 863064, 863065, 863066, 863068

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    TriVerse Femoral Trial

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215098421·

    Engage Partial Knee System

    FDA UDI
    Engage UNI LLC·B695151067000A0·Slap Hammer

    EQUINOXE

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code KWT·February 6, 2019

    A7 ANESTHESIA SYSTEM

    FDA Adverse Event
    Malfunction ·SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO. LTD.·Product code BSZ·February 15, 2017

    SYNCHROMED II

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·June 6, 2013

    DEPUY ASR XL FEM IMP SIZE 43

    FDA Adverse Event
    Injury ·DEPUY INTL., LTD.·Product code KWA·June 30, 2011

    GE OEC 9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·September 9, 2008

    INVISION¿ TOTAL ANKLE SYSTEM

    FDA Adverse Event
    Injury ·WRIGHT MEDICAL TECHNOLOGY INC·Product code HSN·July 18, 2022

    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