BEUDAMED
    13 results · 28ms · Sources: EU EUDAMED, US FDA

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    UVA HEX UNIT

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Bioplate®

    FDA UDI
    Bioplate, Inc.·M3848133071·Straight Compression Plate - 1.9mm - 2 hole - 1...

    OMEGATRAC, MODEL Z105

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    GL GOODLIFE SERIES BLOOD GLUCOSE MONITORING SYSMTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    COBLATOR II

    FDA Adverse Event
    Malfunction ·ARTHROCARE CORPORATION·Product code GEI·March 28, 2014

    VIRTUOSO VR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL, INC.·Product code LWS·October 31, 2012

    SOLARA 3G DEMO 3 LOW SHEAR RECLINE/20 IN H MATRX PB BACK

    FDA Adverse Event
    Malfunction ·INVAMEX·Product code IOR·June 2, 2015

    3.7MM COCR DYNAMIC LOCKING SCREW SLF-TPNG/28MM-STERILE

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code HWC·April 15, 2013

    CO2 Incubators (General Purpose Incubator), model numbers 370, 371, 380, 381, 3307, 3308, 3310, 3311, 3540, 3541, 3542, 3543, 3584, 3585, 3598, and 3599. Product Usage: Incubators are designed to maintain an optimal environment for the incubation of tissue and cell samples. These models are designed to maintain temperature, carbon dioxide, and humidity levels.

    FDA Recall
    Terminated ·Thermo Fisher Scientific (Asheville) LLC·Product code JTQ·November 29, 2012

    CO2 Incubators (General Purpose Incubator), model numbers 370, 371, 380, 381, 3307, 3308, 3310, 3311, 3540, 3541, 3542, 3543, 3584, 3585, 3598, and 3599. Product Usage: Incubators are designed to maintain an optimal environment for the incubation of tissue and cell samples. These models are designed to maintain temperature, carbon dioxide, and humidity levels.

    FDA Enforcement
    Class II ·Terminated·Thermo Fisher Scientific (Asheville) LLC·April 17, 2013

    CS Uni-Directional w Auto ID, Product Number D135303; REPROCESSED ELECTROPHYSIOLOGY CATHETER

    FDA Enforcement
    Class II ·Ongoing·Stryker Sustainability Solutions·May 20, 2026

    Dynamic Locking Screw System (DLS) 3.7mm & Dynamic Locking Screw (DLS) 5.0mm; intended for use in long bone fractures, the fixation of osteopenic bone, the fixation of osteotomies, and for the fixation of non-unions and malunions.

    FDA Enforcement
    Class II ·Terminated·Synthes (USA) Products LLC·September 30, 2015

    Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024