BEUDAMED
    13 results · 21ms · Sources: EU EUDAMED, US FDA

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    Complement Kit Cases

    FDA 510(k)
    FDA Class 2 ·General Hospital

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526159525·PROTECT.EPI ELBOW SUPPORT GRAY IV

    Dornier MedTech

    FDA UDI
    DORNIER MEDTECH AMERICA, INC.·00810116022380·600 micron core/1040 micron OD Luer Lock Diode ...

    UROMAX ULTRA BALLOON DILATATION CATHETER

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    BAYER ADVIA 1650 SPECIAL CHEMISTRY CALIBRATOR

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    LONG NAIL KIT R1.5, LEFT 10X260MM X 125

    FDA Adverse Event
    Malfunction ·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·June 16, 2010

    MINICAP PD TRANSFER SET (EASY-LOCK) WITH TWIST CLAMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code KDJ·November 17, 2008

    UNKNOWN ZIMMER KNEE

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code JWH·August 23, 2011

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 17, 2013

    NA

    FDA Adverse Event
    Malfunction ·ROCHE MOLECULAR SYSTEMS, INC·Product code MZF·August 14, 2017

    NA

    FDA Adverse Event
    Malfunction ·ROCHE MOLECULAR SYSTEMS, INC·Product code MZF·August 14, 2017

    The Covera Vascular Covered Stent is a flexible, self-expanding endoprothesis comprised of ePTFE encapsulating a nitinol stent framework. The inner lumen of the covered stent is carbon impregnated.

    FDA Enforcement
    Class II ·Ongoing·Bard Peripheral Vascular Inc·February 15, 2023

    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