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

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    GraftMax Button, ALB with Cradle, GraftMax Button, BTB with Cradle

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    AGC TRADITION KNEE SYSTEM

    FDA UDI
    Biomet Orthopedics, LLC·00880304240605·

    Oticon

    FDA UDI
    Oticon A/S·05707131282903·H11V2, BTE 13 WL 100 TC

    NobelProcera®

    FDA UDI
    Nobel Biocare AB·07332747099515·Procera Implant Bridge Ti Impl Level 8 unit

    Endo-Model Knee System - Instruments

    FDA UDI
    WALDEMAR LINK GmbH & Co. KG·04026575038282·Periosteal elevator, reusable - Endo Model Knee...

    ENGAGE

    FDA UDI
    Smith & Nephew, Inc.·00885556875728·FEMORAL DOWNSIZING GUIDE 4 ONLY ...

    Engage Partial Knee System

    FDA UDI
    Engage UNI LLC·B6951510370010·Femoral Downsizing Guide Right Medial 2-3 / 5-8

    Engage Partial Knee System

    FDA UDI
    Engage UNI LLC·B6951510370040·Femoral Downsizing Guide Right Medial 4 Only

    EG V1 (BL) SELF MONITORING GLUCOSE TEST SYSTEM MODEL: EPS10017

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    IMAGEQUBE PACS

    FDA 510(k)
    FDA Class 2 ·Radiology

    Engage Partial Knee System

    FDA UDI
    Engage UNI LLC·B695151037001A0·Femoral Downsizing Guide Right Medial 2-3 / 5-8

    Engage Partial Knee System

    FDA UDI
    Engage UNI LLC·B695151037004A0·Femoral Downsizing Guide Right Medial 4 Only

    ZEPHYR XL DR

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, CRMD·Product code DXY·January 13, 2014

    SYNCHRON CX® DELTA SYSTEM (CX9)

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER·Product code GKZ·June 6, 2013

    ENDOTAK RELIANCE

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVY·July 6, 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

    Medical Linear Accelerator

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·September 14, 2016