BEUDAMED
    19 results · 20ms · Sources: EU EUDAMED, US FDA

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    STERILE LATEX POWDER FREE SURGICAL GLOVES WITH HYDROGEL COATING

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    DeRoyal

    FDA UDI
    DEROYAL INDUSTRIES, INC.·00749756611688·Shoulder Immobilizer

    EVOS Lumbar Interbody System

    FDA UDI
    Cutting Edge Spine, LLC·00841193109091·HA PEEK EVOS Straight, ,15mmx11mmx 30mm , FLAT ...

    n/a

    FDA UDI
    Ortho Development Corporation·00822409075997·Femoral Broach/Trial 1015

    Biliary Drainage Tube

    FDA UDI
    OLYMPUS MEDICAL SYSTEMS CORP.·04953170046803·

    Super Bypass

    FDA UDI
    TAKAYAMA INSTRUMENTS INC.·04580036674063·SuperBypass SI system Tip, 110mm, 1.5mm [4.5Fr]...

    BIOZORB

    FDA Adverse Event
    Injury ·HOLOGIC, INC.·Product code NEU·September 4, 2025

    CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000

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

    GUIDE CATHETERS AND ACCESSORIES

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DREAMSTATION

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC.·Product code BZD·November 4, 2025

    MAXCEM ELITE

    FDA Adverse Event
    Malfunction ·KERR CORPORATION·Product code EMA·May 14, 2013

    MINUET II ACCESSORY

    FDA Adverse Event
    Malfunction ·ARJOHUNTLEIGH·Product code FSA·April 21, 2011

    3.5MM LCP MEDIAL DISTAL TIBIA PLATE

    FDA Adverse Event
    Injury ·SYNTHES ELMIRA·Product code HRS·August 12, 2008

    ADULT UNHEATED BREATHING CIRCUIT

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BZO·July 16, 2012

    UNK LINX MAGNETIC IMPLANT

    FDA Adverse Event
    Injury ·TORAX MEDICAL, INC.·Product code LEI·August 13, 2025

    smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·March 27, 2024

    paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·October 2, 2024

    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

    Smiths Medical Medfusion Model 3500 Syringe pumps, Item Numbers: a) 3500 b) 3500-0600-00 c) 3500-0600-01 d) 3500-0600-249 e) 3500-0600-50 f) 3500-0600-51 g) 3500-0600-82 h) 3500-306 i) 3500-402 j) 3500-414 k) 3500-415 l) 3500-500 m) 3500E n) 3500VX-306 o) 3500VX-500

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD Inc.·April 24, 2024