BEUDAMED
    14 results · 38ms · Sources: EU EUDAMED, US FDA

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    TULIP CONDOM

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    SOLIDEA

    FDA UDI
    CALZIFICIO PINELLI SRL·08300496050360·TOP, SIZE L, NOISETTE, MICRO-MASSAGING TOP WITH...

    GALILEO® TROCHANTERIC NAIL, LEFT, Ø10mm x 36cm x 130°

    FDA UDI
    ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665014990·

    PRINCETON

    FDA UDI
    Princeton Medical Group, Inc.·00810158215023·GRASPING FORCEPS DAVIS & GECK 3X2 TEETH SINGLE ...

    PRINCETON

    FDA UDI
    Princeton Medical Group, Inc.·00810158217980·GRASPING FORCEPS REDDICK-OLSEN 5MM Ø 36CM WORKI...

    Mariner Outrigger

    FDA UDI
    Seaspine Orthopedics Corporation·10889981173074·L Con, Side-Loading, R, 8mm, 360mm

    ABR-2000

    FDA 510(k)
    FDA Class 2 ·Neurology

    RX G-UNIVERSAL

    FDA 510(k)
    FDA Class 2 ·Dental

    MLX 300W XENON LIGHTSOURCE

    FDA Adverse Event
    Malfunction ·INTEGRA BURLINGTON MA INC·Product code FCW·April 8, 2013

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·September 1, 2014

    FLEXTEND

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVN·April 12, 2011

    Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.

    FDA Enforcement
    Class II ·Terminated·Belmont Instrument Corporation·October 24, 2012

    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

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024