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

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    Sonoma Fifth Metatarsal Repair System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ON CALL PLUS DIABETES MONITORING SOFTWARE

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    SYDNEY IVF SPERM CRYOPRESERVATION BUFFER

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/10 MM L

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·September 21, 2018

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/10 MM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·November 11, 2022

    SROM*STM ST,30+4L NK,16X11X150

    FDA Adverse Event
    Injury ·1818910 DEPUY ORTHOPAEDICS, INC.·Product code MRA·June 11, 2013

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE CORPORATION·Product code KDJ·July 13, 2011

    PROLIEVE TEMPERATURE MONITOR

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code MEQ·September 12, 2008

    BIO-CORKSCREW FT, 5.5MM

    FDA Adverse Event
    Injury ·ARTHREX, INC·Product code HWC·December 9, 2008

    ECOLAB MICROTEK Rolled Probe Cover, 2.6 cm x 20 cm (1 in x 8 in), Ref PC0906, packaged 1 probe cover/pouch, 25 pouches/carton, 2 cartons/shipping case, Sterile, RX. To be used as a physical barrier for protection against the effects of environmental exposure (e.g. body fluids, gels) and/or to maintain the required hygienic level of various diagnostic or surgical procedures which utilize a transducer (probe).

    FDA Enforcement
    Class III ·Terminated·ECOLAB INC·July 11, 2018

    Jackson-Pratt Silicone Round Drain, 10FR. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a radio-opaque section of tubing which has perforations or ducts. The wound drain is surgically placed in a surgical wound site using a trocar. Blood and fluids are collected through a wound drain into a fluid collection reservoir. Wound drains are used to remove exudates from wound sites. Trocars, drains and reservoirs are for a single patient use only and should be discarded after use

    FDA Enforcement
    Class II ·Terminated·Cardinal Health 200, LLC·May 31, 2017

    RECLAIM DISTAL TAPERED, Angled Distal Stem, various sizes. Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic Manual Surgical Instrument, used to ensure the locking taper surface of the Distal Stem is protected during proximal preparation.

    FDA Enforcement
    Class II ·Terminated·DePuy Orthopaedics, Inc.·July 30, 2014

    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