BEUDAMED
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    AZUR DETACHABLE 35

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Unity Total Knee System

    FDA UDI
    CORIN LTD·05055343897331·Femoral Distal Augment 5 mm sizes 8 & 9

    Bernafon

    FDA UDI
    Bernafon AG·05711584022733·MD1 NR, PS GR MONDO 1

    JOBST UltraSheer

    FDA UDI
    BSN MEDICAL, INC.·00035664223168·ULTRA SHEER 20-30 MM HG THIGH W/DOT BAND CLOSED...

    APEX PS Knee

    FDA UDI
    Omni Life Science, Inc.·00841690113607·PS-C Insert, Size 3 x 16mm

    ZAVATION ROD CONNECTOR

    FDA UDI
    Zavation LLC·00197157016401·ROD CONNECTOR, PARALLEL SIDE LOADING/CLOSED 16m...

    NITINOL TC ELECTRODE

    FDA Adverse Event
    Malfunction ·COSMAN MEDICAL·Product code GXI·June 8, 2017

    VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    GLUCOSE SHEPHERD BLOOD GLUCOSE MONITORING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    NITINOL TC ELECTRODE

    FDA Adverse Event
    Malfunction ·COSMAN MEDICAL·Product code GXI·April 5, 2017

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code LKK·May 21, 2013

    14CM ANGLE ATTACHMENT

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code HBC·September 26, 2014

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·June 13, 2011

    Integra Small Rickham -Style Reservoir Rx Only Sterile for Single Use Only Integra NeuroSciences 311 Enterprise Drive Plainsboro, NJ 08536 USA Made in the USA NL 850-1121 Provides access to the lateral cerebral ventricles via hypodermic puncture. It is useful in obtaining CSF (cerebral spinal fluid_ samples for cytological and chemical studies, for monitoring ventricular fluid pressure and for ventricular drainage. The reservoir provides easy access to the lateral ventricles and to cystic tumors for the injections of chemotherapeutic agents and/or radio-isotopes. The rickham reservoir may be utilized in hydrocephalic patients as a component in systems designed to shunt CSF from the lateral ventricles into either the right atrium of the heart of the peritoneum.

    FDA Enforcement
    Class II ·Terminated·Integra LifeSciences Corp.·January 15, 2014