BEUDAMED
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    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Adler Instrument Company

    FDA UDI
    Adler, Inc.·00810123206216·Tissue Forceps, 1x2 teeth

    MIERU (ETAFILCON A) DAILY WEAR CONTACT LENS CLEAR AND VISIBILITY TINT, WITH UV BLOCKER

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    PROFEMUR XM DISTAL CENTRALIZER

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SURESTEP

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code CGA·April 26, 2000

    EVOLUT PRO PLUS VALVE

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES DIVISION·Product code NPT·May 22, 2023

    FLO-GARD 6201 VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE·Product code FRN·November 17, 2008

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·September 1, 2011

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·July 16, 2013

    DUROM ACETABULAR COMPONENT 50/44, CODE J

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code KWA·August 29, 2018

    Membrane Changer Single-Use, REF MC, each package contains 3 changers; Membrane Changer Reloadable, REF MC-R, each package contains 3 changers; and Membrane Changer Insert, REF MC-I, each package contains 5 inserts. All are components of the Sentec Digital Monitoring System (SDMS).

    FDA Enforcement
    Class II ·Ongoing·SenTec AG·September 27, 2023

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

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