BEUDAMED
    14 results · 21ms · 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 ×

    TBS iNsight

    FDA 510(k)
    FDA Class 2 ·Radiology

    CHEMSTRIP ® 10 MD

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JIL·October 26, 2017

    REPROCESSED ENDOSCOPIC TROCAR

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

    CPR FACE MASK

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    APOLLO GENERATOR

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code GWG·June 11, 2015

    STARDRIVE SCREWDRIVER SHAFT T8 105MM

    FDA Adverse Event
    Malfunction ·SYNTHES SELZACH·Product code KWQ·September 27, 2016

    8800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·October 2, 2014

    NONE

    FDA Adverse Event
    Malfunction ·MEDTRONIC, INC.·Product code DTE·June 7, 2013

    XIA 3 TITANIUM TORQUE WRENCH

    FDA Adverse Event
    Malfunction ·STRYKER SPINE BORDEAUX·Product code LXH·June 23, 2011

    Synovis VASCU-GUARD Peripheral Vascular Patch in the following sizes and product codes: 1 cm x 6 cm, product code VG0106N, 0.8 cm x 8 cm, product code VG0108N, 1 cm x 10 cm, product code VG0110N, and 2 cm x 9 cm, product code VG0209N. VASC U-GUARD is prepared from bovine pericardium which is cross-linked with glutaraldehyde. Sterilized using aseptic processing techniques. The pericardium is procured from cattle originating in the United States. VASC-Guard is chemically sterilized using ethanol and propylene oxide. UPDATE 9/1/2016 Retrieval of devices only includes Synovis VASCU-GUARD Peripheral Vascular Patch in the following sizes and product codes: 1 cm x 6 cm, product code VG0106N, 0.8 cm x 8 cm, product code VG0108N.

    FDA Enforcement
    Class II ·Terminated·Baxter Healthcare Corp.·August 24, 2016

    Integrity 1.1. Integrity is the interface and control software for the Elekta range of medical digital linear accelerators and is intended to assist a licensed practitioner in the delivery of radiation to defined target volumes.

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·April 9, 2014

    ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

    FDA Enforcement
    Class II ·Ongoing·Elekta, Inc.·December 13, 2023

    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 2110. 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