BEUDAMED
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    SMITH & NEPHEW SMF HIP STEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    EVOS Lumbar Interbody System

    FDA UDI
    Cutting Edge Spine, LLC·00841193100203·EVOS Straight HA PEEK 12mm x 9mm x 26mm Biconve...

    MiniSPC Button

    FDA UDI
    APPLIED MEDICAL TECHNOLOGY, INC.·00842071152314·12F x 3.0cm MiniSPC Low Profile Suprapubic Cath...

    EXACTECH BIOLOXDELTA / BIOLOX FEMORAL HEADS, 28MM OD, 32MM OD, 36MM OD, EXACTECH BIOLOX OPTION ADAPTERS/FEMORAL HEADS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SMARTSET HV BONE CEMENT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ACCELERATOR A3600

    FDA Adverse Event
    Malfunction ·INPECO SA·Product code JQP·December 20, 2024

    MENTOR MEMORYGEL BREAST IMPLANT

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code FTR·May 19, 2026

    INTERSTIM

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·May 21, 2013

    INTERMATE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code FRN·September 26, 2014

    ENDO GIA ROTICULATOR 45-2.5 SULU

    FDA Adverse Event
    Death ·UNITED STATES SURGICAL·Product code GDW·June 7, 2011

    OsteoMed OsteoPower Power Console: -OsteoMed OsteoPower Power Console 2 REF 450-0021-00 -OsteoMed D-Power Control Console 2 REF 450-0021-01 -Power Control Console 2 REF ECOS-450-0021-00 -OsteoMed OsteoPower Power Console 2i REF 450-0005-00 -OsteoMed D-Power Control Console 2i REF 450-0005-01 -Power Control Console 2i REF ECOS-450-0005-00 OsteoMed Footswitches: -OsteoMed BMF Footswitch REF 450-0390 -D-Bi-Directional Master Footswitch REF 450-0380 -D-Uni-Directional Footswitch II REF 450-0350 -D-Bi-Directional Footswitch II REF 450-0360 -D-Uni-Directional Master Footswitch REF 450-0370

    FDA Enforcement
    Class II ·Ongoing·Osteomed, LLC·December 15, 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