BEUDAMED
    15 results · 29ms · Sources: EU EUDAMED, US FDA

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    System Sophi

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    Darby Dental Supply, LLC

    FDA UDI
    DARBY DENTAL SUPPLY, LLC·00889813058626·STERILE CARBIDE BUR FG701SURG

    Cardiovascular Procedure Kit

    FDA UDI
    Terumo Cardiovascular Systems Corporation·00699753468320·

    LOCATOR R-Tx

    FDA UDI
    Zest Anchors, LLC·00840481125973·LOCATOR R-Tx Attachment System, 3.5 EC Implants...

    Good Works

    FDA UDI
    Bosma Enterprises·00818634025029·Good Works Performance Pro Small 100/Box

    Bradshaw Medical Inc.

    FDA UDI
    Bradshaw Medical, Inc.·00810019931222·BIT, BLADE SMALL .04" X .19" 1/4 SQ

    Zimmer Nexel Total Elbow Ulnar Cement Diverter

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MODIFICATION TO: XCEED NITINOL SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    G7

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·May 21, 2025

    INTERMATE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code FRN·November 14, 2014

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·September 15, 2011

    GYNECARE GYNEMESH

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code FTL·July 26, 2013

    Direct Drive Clip Applier CA090, indicated for ligation of tubular structures or vessels in laparoscopic and general surgical procedures. Distributed individually and in kits.

    FDA Enforcement
    Class II ·Terminated·Applied Medical Resources Corp·May 18, 2016

    Achieva 1.5T

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·November 29, 2023

    Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·July 25, 2012