BEUDAMED
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    MULTIGAS UNIT, MODEL AG-920RA

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.

    FDA Enforcement
    Class II ·Terminated·Belmont Instrument Corporation·October 24, 2012

    Affiniti™

    FDA UDI
    TORNIER, INC.·00846832002023·

    Weropress Polymer C34

    FDA UDI
    Merz Dental GmbH·D7091020046·Weropress Polymer C34, 100g

    Humelock II Cemented Shoulder System

    FDA UDI
    FX SOLUTIONS·03701037305645·RING CUTTING GUIDE Ø46 mm

    L-buttress plates, left, 4 holes, 87mm

    FDA UDI
    mahe medical gmbh·EMAH00200460040·L-buttress plates, left, 4 holes, 87mm

    Cosmolock

    FDA UDI
    Kalitec Direct LLC·B07311K0100460·ASSEMBLY, CADDIE, CURVED RODS WITH STOPS

    mahe medical GmbH

    FDA UDI
    mahe medical gmbh·04050659181625·L-buttress plates, left, 4 holes, 87mm _x000D_...

    Intelliguides

    FDA UDI
    Mios Marketing, LLC·G2710420200460·Anterior Lateral Closing Wedge Osteotomy Guide,...

    Intelliguides

    FDA UDI
    Mios Marketing, LLC·G2710410200460·Anterior Closing Wedge Osteotomy Guide, 20mm x ...

    KNIGHT ENDOSCOPIC SPINE SYSTEM (KESS)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MODIFICATION TO AUTOMATED NON-INVASIVE BLOOD PRESSURE MONITOR, MODEL BPM-100

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ENDURANT II ABDOMINAL STENT GRAFT SYSTEM

    FDA Adverse Event
    Death ·MEDTRONIC IRELAND·Product code MIH·March 25, 2013

    ASR ACETABULAR CUPS 54

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·March 11, 2011

    FREESTYLE

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC.·Product code LFR·May 25, 2007

    3T 16ch Flex SPEEDER Coil, Large, NeoCoil Part Number NC046200, Toshiba Medical Systems Model MJAJ-222A. The NeoCoil 3T 16ch Flex SPEEDER Coils are tuned to receive RF frequency corresponding to the proton precession in a 3 tesla magnetic field, which is governed by the Larmor equation. To be used in conjunction with Toshiba 3T Magnetic Resonance Scanners with ODU connectors to produce diagnostic images of the upper and lower extremities, chest, abdomen, pelvis, head, neck and spine that can be interpreted by a trained physician.

    FDA Enforcement
    Class II ·Terminated·NeoCoil, LLC·August 10, 2016

    Tornier AFFINITI Humeral Head Standard 44mm x 21mm, Catalog No. 0020046. Sterile. Manufactured for Tornier, 10750 Cash Rd., Stafford, TX 77477. Tornier's Affiniti Shoulder System is a non-constrained glenohumeral prosthesis intended for use as a total or hemi-shoulder replacement system. The total shoulder consists of a metal humeral stem, a metal humeral head and an ultrahigh molecular weight polyethylene glenoid. The hemi-shoulder consists of a metal humeral stem and a metal humeral head.

    FDA Recall
    Terminated ·Tournier, Inc.·Product code KWS·October 20, 2008