BEUDAMED
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    DISPOSABLE HEMOSTATIC Y-CONNECTORS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    JOBST forMen Casual

    FDA UDI
    BSN MEDICAL, INC.·00035664131326·FOR MEN CASUAL 30-40 MM HG KNEE HIGH CLOSED TOE...

    Gruve

    FDA UDI
    Life Spine, Inc.·00190837089498·10mm Micro Cervical Drill

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·March 14, 2023

    FRESHKONALLURING EYES, FRESHKON COLORS FUSION, FRESHKONCOLORS FUSION SPARKLERS, FRESHKON MOSAIC, FRESHKON GLITZI

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    SIGN IM NAIL

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    UNIVEIRSAL RECIPROCATING SAW ATTACHMENT

    FDA Adverse Event
    Malfunction ·ZIMMER SURGICAL S.A.·Product code GFA·May 9, 2013

    GRANUFLO

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·September 22, 2014

    ASR ACETABULAR CUPS 58

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·May 20, 2011

    EMBLEM S-ICD Model A209

    FDA Enforcement
    Class I ·Terminated·Boston Scientific Corporation·February 17, 2021

    Microtek Medical, Inc. ORS Fluid Warming and Slush Drapes, Model #'s ORS-100, ORS-110, ORS-130, ORS-300, ORS-301, ORS-320, ORS-321, ORS-325, ORS-330, ORS-331 and ORS-2200. The ORS Fluid Warming and Slush Drapes are individually wrapped and placed in poly-Tyvek pouches with a label insert, then packaged as 24 per case in a labeled corrugated shipper box. Intended for use during various surgeries where warm irrigation, slush and/or cold solution are required.

    FDA Enforcement
    Class II ·Terminated·Ecolab Inc·September 30, 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 L231, PROPONENT DR EL MRI Pacemaker

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