BEUDAMED
    16 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 ×

    OSTEOSELECT DEMINERALIZED BONE MATRIX PUTTY

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450521106·

    LAKONG ULTRASONIC SCALER

    FDA 510(k)
    FDA Class 2 ·Dental

    HL888HA

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    NAIL HOLDING SCREW

    FDA Adverse Event
    Malfunction ·STRYKER OSTEOSYNTHESIS KIEL·Product code LXH·January 6, 2012

    5.0 CM SHORT ATTACHMENT

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code HBC·May 24, 2013

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Injury ·DEXCOM, INC.·Product code MDS·September 30, 2014

    VISIAN ICL (IMPLANTABLE COLLAMER LENS)

    FDA Adverse Event
    Injury ·STAAR SURGICAL CO.·Product code MTA·June 14, 2011

    CAPIOX RX OXYGENATOR

    FDA Adverse Event
    Malfunction ·TERUMO MEDICAL CORPORATION·Product code DTZ·May 26, 2023

    CAPIOX RX OXYGENATOR

    FDA Adverse Event
    Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DTZ·April 20, 2018

    CAPIOX RX OXYGENATOR

    FDA Adverse Event
    Injury ·TERUMO CORPORATION, ASHITAKA·Product code DTZ·July 31, 2024

    CAPIOX HOLLOW FIBER OXYGENATOR/ARTERIAL FILTER

    FDA Adverse Event
    Malfunction ·TERUMO MEDICAL CORPORATION·Product code DTZ·January 31, 2024

    LIFEWISE BLOOD PRESSURE MONITOR

    FDA Adverse Event
    Injury ·RADIOSHACK·Product code DXN·October 20, 2004

    CAPIOX®RX

    FDA Adverse Event
    Injury ·TERUMO CORPORATION, ASHITAKA·Product code DTZ·December 9, 2024

    CAPIOX RX OXYGENATOR

    FDA Adverse Event
    Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DTZ·July 5, 2018

    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