BEUDAMED
    14 results · 28ms · Sources: EU EUDAMED, US FDA

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    Phasix Mesh

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Cavitron®

    FDA UDI
    Dentsply Professional·D00381614241·Cavitron® Select™ SPS™ Package. Contents: 30K® ...

    Oticon

    FDA UDI
    Oticon A/S·05707131305305·SENSEI PRO SP, BTE 13 WL 110 AQM

    Ceramco® II Silver™

    FDA UDI
    Dentsply International Inc.·D0011614240·

    CELSITE/ CELSITE CONCEPT, ACCESS PORTS

    FDA 510(k)
    FDA Class 2 ·General Hospital

    PHARMACARIBE INHALED SALINE SOLUTIONS

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·July 8, 2024

    VNGD RP DD BRG 12X80 MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JWH·April 5, 2022

    VANGUARD CR ILOK FEM-LT 80 80

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JWH·April 5, 2022

    DFN12MM-240MM NAIL

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HTY·June 11, 2013

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 13, 2011

    COLLEAGUE 3CX VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·September 17, 2008

    ANATOMIC

    FDA Adverse Event
    Malfunction ·AMPLITUDE·Product code JWH·December 11, 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