BEUDAMED
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    COROENT SINGLE TAB SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Novo Surgical Inc.

    FDA UDI
    NOVO SURGICAL, INC.·00842331139048·wagner plastic surgery scissors, fine pattern, ...

    COMPACT WHEELCHAIR PLATFORM

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    TURBOHAWK PERIPHERAL PLAQUE EXCISION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SM/EXT-FIX RADIOLUC

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code KWP·May 29, 2013

    HI-TORQUE WHISPER MS GUIDE WIRE

    FDA Adverse Event
    Death ·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code DQX·August 21, 2008

    SECURA DR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL, INC.·Product code LWS·June 16, 2011

    AMISTEM H, HA COATED STEM SIZE 6 STD

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·December 30, 2016

    VERSAFITCUP ACETABULAR SHELL CC Ø 54

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code MEH·April 27, 2017

    Ultraview SL Command Modules, Model 91496, with the Masimo SpO2 PCBA, PN: 010-1636-02. The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare Inc·May 13, 2015