BEUDAMED
    17 results · 22ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    SPEEDLOCK KNOTLESS FIXATION DEVICE, 3MM DRILL, 3MM+ DRILL, PATHFINDER OBTURATOR & SHARP TIPPED OBTURATOR, LOW PROFILE DR

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ArgenZ ST 98x20 ML A4B

    FDA UDI
    ARGEN CORPORATION, THE·D818130196·Dental porcelain/ceramic restoration kit

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450627907·

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450185636·

    BD ULTRA-FINE¿ MINI PEN NEEDLES 5MM (3/16¿) 31G

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON AND CO.·Product code FMI·June 9, 2023

    Baumgartner Needle Holder

    FDA UDI
    ELMED INSTRUMENTS(PVT)LTD.·G165SU130196140·Intended Use: Baumgartner Needle Holder is comm...

    POWDER-FREE VINYL PATIENT EXAMINATION GLOVES

    FDA 510(k)
    FDA Class 1 ·General Hospital

    DYONICS POWER CONTROL UNIT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PEN NDL 31GA 5MM 100BX 1200 USA

    FDA Adverse Event
    Malfunction ·BECTON DICKNSON AND CO. - DUN LAOGHAIRE CO, IRELAND·Product code FMI·April 12, 2024

    PEN NDL 31GA 5MM 100BX 1200 USA

    FDA Adverse Event
    Malfunction ·BECTON DICKNSON AND CO. - DUN LAOGHAIRE CO, IRELAND·Product code FMI·April 18, 2024

    VASOVIEW 6 ACCESSORY PACK

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOVASCULAR, LLC·Product code GEI·May 21, 2013

    HYPERFORM OCCLUSION BALLOON SYSTEM

    FDA Adverse Event
    Malfunction ·IRVINE·Product code MJN·September 30, 2014

    DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·October 6, 2015

    BD PHASEAL PROTECTOR P50J

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code ONB·July 7, 2023

    POLYMETHYLMETHACRYLATE BONE CEMENT

    FDA Adverse Event
    Injury ·SYNTHES SELZACH·Product code NDN·August 16, 2016

    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

    Ultraview SL Command Modules, Model 91496, with the Masimo SpO2 PCBA, PN: 010-1636-02. The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare Inc·May 13, 2015