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

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    Z-RAY INTRA-ORAL DIGITAL RADIOGRAPHY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    Oticon

    FDA UDI
    Oticon A/S·05707131260512·RIA PRO, RITE 312 WL SIL

    Brasseler USA

    FDA UDI
    Provision·B504OMKM332060·

    Humelock Reversed Shoulder

    FDA UDI
    FX SOLUTIONS·03701037301388·HUMELOCK REVERSED STEM TA6V CEMENTED Ø32/06

    SMALL BONE BLADES

    FDA UDI
    Peter Brasseler Holdings, LLC·00887919094241·KM33-206

    Brasseler USA

    FDA UDI
    Provision·00810041064929·

    NA

    FDA UDI
    STERILMED, INC.·10888551017091·SAW BLADE MICRO OSCILLATING 9 TEETH/CM STRYKER ...

    PENTAX

    FDA Adverse Event
    Malfunction ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code ODG·July 24, 2021

    RAUMEDIC- ICP-MONITORING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Neurology

    EPW FOLDABLE POWER WHEELCHAIR, EPW-03

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    PENTAX

    FDA Adverse Event
    Malfunction ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code ODG·July 21, 2021

    COOK® CERVICAL RIPENING BALLOON

    FDA Adverse Event
    Malfunction ·COOK INC·Product code PFJ·July 18, 2016

    BD VACUTAINER PPT PLASMA PREPARATION TUBE K2E 9.0 MG

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code PJE·April 22, 2021

    COOK® CERVICAL RIPENING BALLOON

    FDA Adverse Event
    Malfunction ·COOK INC·Product code PFJ·July 19, 2016

    PINNACLE MTL INS NEUT36IDX54OD

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code KWA·May 29, 2013

    AUTOCLAVABLE ARTHROSCOPE STERILIZATION TRAY

    FDA Adverse Event
    Malfunction ·STRYKER ENDOSCOPY SAN JOSE·Product code HRX·May 9, 2011

    PT RETURN GROUNDING PAD

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code ODR·August 22, 2008

    Glucose HEX R1 reagent sold by Pointe Scientific; in vitro diagnostic, Catalog nos 3-HG920-R1, 7-HG920-R1-67, 7-HG920-R1-600 and 7-HG920-R1-800.

    FDA Recall
    Terminated ·Pointe Scientific, Inc.·Product code CFR·June 7, 2006

    Cobas 8000 Modular Series system; Software Version 05-02 and 06-03; UDI: 05641446001

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·February 28, 2018

    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