BEUDAMED
    14 results · 26ms · 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 ×

    RHINO-LARYNGOFIBERSCOPE OLYMPUS ENF TYPE-XP

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517288509·CoRoent® XL-CTW, 16x22x60mm, 10°

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517300577·CoRoent® XLK, 16x18x60mm 10°

    CD HORIZON® Spinal System

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00885074362359·SCREW 7221660 HA COATED CANN 6.5 X 60

    Katalyst™ Bipolar Radial Head System

    FDA UDI
    INTEGRA LIFESCIENCES CORPORATION·10381780065845·The Katalyst Radial Stem restores the support a...

    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

    Vu aPod™ - L

    FDA UDI
    Seaspine Orthopedics Corporation·10889981046613·LATERAL TRIAL, WIDE, STANDARD, 16mm X 23mm X 60mm

    KMTI Hip Replacement System, Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    K-ASSAY LP(A) ASSAY

    FDA 510(k)
    FDA Class 2 ·Immunology

    CAPTURE-R READY-SCREEN 3

    FDA Adverse Event
    Malfunction ·IMMUCOR, INC.·Product code QHT·December 18, 2020

    GII PS HI FLEX ISRT SZ 3-4 9

    FDA Adverse Event
    Injury ·SMITH & NEPHEW ORTHOPAEDICS GMBH·Product code JWH·November 3, 2014

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·August 24, 2011

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·July 11, 2013

    Brand Name: SenTiva" Product Name: VNS Therapy" SenTiva", Model 1000 Model/Catalog Number: 1000 Software Version: NA Product Description: The LivaNova VNS Therapy" System, used for Vagus Nerve Stimulation (VNS), consists of an implantable VNS Therapy generator, lead, and external programming system used to change stimulation settings. The generator is an implantable, multi-programmable pulse generator that delivers electrical signals to the vagus nerve through the lead. The generator is housed in a hermetically sealed titanium case and is powered by a single battery. Electrical signals are transmitted from the generator to the vagus nerve by the lead. The lead and the generator make up the implantable portion of the VNS Therapy System. The VNS Therapy Programming System includes a computer pre-installed with VNS Therapy programming software and a programming wand. The physician uses the programming system to read and change generator settings. The Model 1000 Generator was commercially approved for distribution in the U.S. on October 3, 2017 via PMA P970003/S210. Component: The LivaNova VNS Therapy" System, used for Vagus Nerve Stimulation (VNS).

    FDA Enforcement
    Class II ·Ongoing·LivaNova USA, Inc.·February 5, 2025