BEUDAMED
    16 results · 24ms · Sources: EU EUDAMED, US FDA

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    geko T-2 and geko T-3 Neuromuscular Stimulators

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Orthos

    FDA UDI
    ORMCO CORPORATION·00889989029932·ORTHOS CM SST ARCH 021X025 LOSM PK10

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690198918·AK3 Congruent Insert Trial Size 1, 13mm

    NOVO Surgial

    FDA UDI
    NOVO SURGICAL, INC.·00842331184093·Jeweler's Bipolar Forceps, 0.4 mm tip, 4" (10.0...

    GUARDIAN II NC HEMOSTASIS VALVE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MAXIMA V, THREE WHEEL SCOOTER, MODEL SC900V MAXIMA V, FOUR WHEEL SCOOTER, MODEL SC940V

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    MOSAIC AORTIC BIOPROSTHETIC HEART VALVE

    FDA Adverse Event
    Death ·MEDTRONIC HEART VALVES DIVISION·Product code DYE·December 17, 2020

    OBTRYX SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·June 26, 2013

    AKREOS AO MICRO INCISION LENS

    FDA Adverse Event
    Injury ·BAUSCH + LOMB·Product code HQL·July 29, 2011

    J-VAC RESERVOIR

    FDA Adverse Event
    Malfunction ·ETHICON, INC.·Product code GCY·September 26, 2008

    MOSAIC AORTIC BIOPROSTHETIC HEART VALVE

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES DIVISION·Product code DYE·December 17, 2020

    GELFOAM

    FDA Adverse Event
    Injury ·PFIZER, INC. (DEVICE)·Product code LMF·June 3, 2019

    SINGLE USE GUIDWIRE

    FDA Adverse Event
    Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code OCY·April 21, 2020

    ARCHITECT MAGNESIUM, (a) REF 7D70-21, (b) 7D70-31 The Magnesium assay is used for the quantitation of magnesium in human serum, plasma, or urine.

    FDA Enforcement
    Class II ·Terminated·Abbott Laboratories, Inc·March 13, 2019

    SCENARIA View: Software Version V1.08, V1.09B, V1.09C, V1.09D, V1.0B, V1.0C

    FDA Enforcement
    Class II ·Ongoing·FUJIFILM Healthcare Americas Corporation·September 21, 2022

    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