BEUDAMED
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    ACCUWELL TSH, MODEL KAW-TSH-960

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Endo-Carry-on Procedure Kit

    FDA UDI
    MEDIVATORS INC.·40677964013100·Endo Carry-on Procedur Kit contains all of the ...

    PIC

    FDA UDI
    PREMIER DENTAL PRODUCTS COMPANY·00348783000146·PREMIER IMPLANT CEMENT VALUE PACK

    ODYSSEY®

    FDA UDI
    Microport Orthopedics Inc.·M684K00143551·

    artVeneer life

    FDA UDI
    Merz Dental GmbH·D7092001455·artVeneer life lower anteriors, UBS, D2

    PedFuse®

    FDA UDI
    SPINEFRONTIER, INC.·00190361008507·PedFuse Respond, CNL, 7.0mm x 55mm

    TANDEM T: SLIM INSULIN DELIVERY SYSTEM

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES·Product code LZG·February 28, 2014

    GETTIG GUARD

    FDA 510(k)
    FDA Class 2 ·General Hospital

    MODEL 4300 PSARRAY EEG ELECTRODE SET

    FDA 510(k)
    FDA Class 2 ·Neurology

    SEXTANT SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC SOFAMOR DANEK·Product code MCV·October 29, 2009

    LAMITRODE 44

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·March 5, 2013

    ORTHO SUMMIT SAMPLE HANDLING SYSTEM

    FDA Adverse Event
    Malfunction ·HAMILTON BONADUZ AG·Product code JTC·February 25, 2011

    SM204 M-SERIES W/BIG WHEEL

    FDA Adverse Event
    Other ·STRYKER CORP., MEDICAL DIV.·Product code FPO·February 19, 2008

    T:slim Insulin Delivery System Insulin Infusion Pump

    FDA Enforcement
    Class I ·Terminated·Tandem Diabetes Care Inc·February 19, 2014

    UUltrasound System 2300, bkActiv w/battery; Model No. 2300-11; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025

    PM1214 NUANCE SR RF; PM1230 and PM2230 NUANCE MRI; PM2214 NUANCE DR RF These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·October 25, 2017