BEUDAMED
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    LEFORTE NEURO SYSTEM BONE PLATE

    FDA 510(k)
    FDA Class 2 ·Neurology

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526799394·MANUMED ACTIVE WRIST LEFT SAND S

    LOW PROFILE EEG NEEDLE ELECTRODE, MODELS 112-812-18TP, 112-812-48TP, 112-812-60TP, 112-812-72TP, 112-812-96TP, 112-812

    FDA 510(k)
    FDA Class 2 ·Neurology

    28mm x 11mm x 12mm Oblique with Inserter

    FDA UDI
    XENCO MEDICAL LLC·B064XM01128121·28mm x 11mm x 12mm Straight TLIF with Inserter

    28mm x 11mm x 12mm Straight Titanium TLIF with Inserter and Tamp

    FDA UDI
    XENCO MEDICAL LLC·B064XMTL11128121·

    28mm x 11mm x 12mm Straight Titanium TLIF with Inserter and Tamp

    FDA UDI
    XENCO MEDICAL LLC·B064XMTL1112812·

    GAMMA-BSM; BETA-BSM; EQUIVABONE

    FDA 510(k)
    FDA Class 2 ·Dental

    CAROTID GUIDING SHEATH

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Chalgren

    FDA UDI
    CHALGREN ENTERPRISES·00816020020184·Low Profile Needle Electrode, EEG, 12mm x 28g

    Chalgren

    FDA UDI
    CHALGREN ENTERPRISES·00816020020214·Low Profile Needle Electrode, EEG, 12mm x 28g

    Chalgren

    FDA UDI
    CHALGREN ENTERPRISES·00816020020191·Low Profile Needle Electrode, EEG, 12mm x 28g

    Chalgren

    FDA UDI
    CHALGREN ENTERPRISES·00816020020207·Low Profile Needle Electrode, EEG, 12mm x 28g

    Chalgren

    FDA UDI
    CHALGREN ENTERPRISES·00816020020221·Low Profile Needle Electrode, EEG, 12mm x 28g

    LONG NAIL KIT R1.5, TI, LEFT GAMMA3 10X300MM X 12

    FDA Adverse Event
    Injury ·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·November 7, 2012

    STELO GLUCOSE BIOSENSOR SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code SAF·May 9, 2025

    EXp Tibial Insert ; Intended Use of Device(s): The Proven Gen-Flex Total Knee System is intended for: a. Total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis, and/or post-traumatic degenerative problems; and b. Revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present.

    FDA Enforcement
    Class II ·Terminated·Stelkast Co·January 21, 2015

    ANGIOSCULPT PTA SCORING BALLOON CATHETER (OTW)

    FDA Adverse Event
    Malfunction ·ANGIOSCORE, INC·Product code LIT·November 18, 2015

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·UNKNOWN·Product code ITI·May 14, 2013

    ASR ACETABULAR CUPS 50

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·May 18, 2011

    VERSACARE

    FDA Adverse Event
    Malfunction ·HILL-ROM RITTER·Product code FNL·August 15, 2008