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

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    FACTOR V DEFICIENT PLASMA

    FDA 510(k)
    FDA Class 2 ·Hematology

    Medtronic Reusable Instruments

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00673978164977·10.5MM ADJUSTABLE REAMER

    WIN Flexible Nail System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ZIMMER PATIENT SPECIFIC INSTRUMENTS SYSTEM, VERSION 2.0

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TAPER SLEEVE ADAPTER 12/14 +2

    FDA Adverse Event
    Injury ·DEPUY INTL., LTD. - 8010379·Product code KWY·July 6, 2015

    1020279-2013-00007

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code JWH·January 2, 2013

    ADVANTA

    FDA Adverse Event
    Malfunction ·HILL-ROM INC·Product code FNL·February 14, 2014

    GE HC OEC 9900 Elite and GE OEC 9800 Fluoroscopes Snubber Boards are a PCB with a 70 amp fuse to provide fused protection of internal system components from the high voltage system components, such as the X-ray tube or High Voltage Transformer. System model number A349855, Snubber Board number 00-880405-03 rev 5. This product is used for image intensified fluoroscopic x-rays for interventional radiologic procedures.

    FDA Enforcement
    Class II ·Terminated·GE OEC Medical Systems, Inc·August 29, 2012

    Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 12, 2020