BEUDAMED
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    BINGO PRO

    FDA 510(k)
    FDA Unclassified ·Unknown

    JOBST Anti-Em

    FDA UDI
    BSN MEDICAL, INC.·00035664114749·ANTI-EMB STOCKINGS KNEE HIGH CLOSED TOE LARGE R...

    MAXCUT CARBIDE BUR (10/pk) FGSS 558

    FDA UDI
    SCOTT'S DENTAL SUPPLY L.L.C.·D77811114741·MAXCUT CARBIDE BUR (10/pk) Shape: Cross Cut Str...

    Drill Bit

    FDA UDI
    Jeil Medical Corporation·08800089476367·

    MicroSelectron Digital

    FDA UDI
    Nucletron B.V.·08717213033771·Coupling Treatment Tube for 5F Flexibles (14)

    POWDERED SYNTHETIC (YELLOW) VINYL PATIENT EXAMINATION GLOVES

    FDA 510(k)
    FDA Class 1 ·General Hospital

    MD VISION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    LIBERTÉ?

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code MAF·May 14, 2013

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·September 23, 2014

    ASR UNI FEMORAL IMPL SIZE 41

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·May 13, 2011

    MR Coils The MR Coil is intended to be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the anatomy of interest that can be interpreted by a trained physician.

    FDA Enforcement
    Class III ·Terminated·Invivo Corporation·October 28, 2020

    IOL Master 500: Software versions 7.5 and 7.7; Ophthalmic: IOL Master 500 is intended for biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-to white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil.

    FDA Enforcement
    Class II ·Terminated·Carl Zeiss Meditec AG·December 9, 2015

    INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    Model Number L131, ESSENTIO DR EL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025