BEUDAMED
    19 results · 30ms · Sources: EU EUDAMED, US FDA

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    MERCURY SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    UniTip Catheter

    FDA UDI
    Unisensor AG·07640172973868·

    UniTip Catheter

    FDA UDI
    Unisensor AG·07640172973783·

    DUOCOOL PAIN MANAGEMENT PROBE, MODEL OSP-17-180-20

    FDA 510(k)
    FDA Class 2 ·Neurology

    SMARTLITE PS PEN-STYLE LED CURING LIGHT

    FDA 510(k)
    FDA Class 2 ·Dental

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·October 3, 2014

    ALTRX NEUT 36IDX64OD

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code LPH·June 3, 2013

    SECURE 3 MED/SURG BED

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FNL·June 1, 2011

    ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code PNO·November 20, 2017

    ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code PNO·December 19, 2017

    ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code PNO·January 8, 2019

    ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code PNO·January 22, 2019

    ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code PNO·January 29, 2018

    ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DQY·January 26, 2018

    ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code PNO·February 12, 2018

    ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code PNO·January 29, 2018

    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

    BD FocalPoint Slide Profiler and BD FocalPoint GS Review Station; Catalog Nos. 490398, 490653, 491085, 491086, 491090, 490189 The BD FocalPoint GS Imaging System is intended to assist in cervical cancer screening of BD SurePath Liquid-based Pap Test slides to detect evidence of squamous carcinoma, adenocarcinoma and their usual precursor conditions.

    FDA Enforcement
    Class III ·Terminated·Becton Dickinson & Co.·October 17, 2018

    cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018