BEUDAMED
    10 results · 19ms · 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 ×

    KOTEX SECURITY TAMPONS (SEVERAL TYPE)

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

    KOTEX NATURAL BALANCE : TAMPON, MENSTRUAL, UNSCENTED : HEB

    FDA Adverse Event
    Malfunction ·KIMBERLY-CLARK CORPORATION CONWAY MILL·Product code HEB·June 21, 2018

    DeRoyal

    FDA UDI
    DEROYAL INDUSTRIES, INC.·00749756732079·MINOR/PLASTIC PACK

    NON-STERILE VINYL EXAMINATION GLOVES

    FDA 510(k)
    FDA Class 1 ·General Hospital

    IF2000 ELECTRICAL MUSCLE STIMULATOR UNIT

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    SOLETRA

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·June 26, 2014

    AMPLATZER® SEPTAL OCCLUDER

    FDA Adverse Event
    Injury ·AGA MEDICAL CORPORATION·Product code MLV·November 11, 2010

    DELTA CER HEAD 11/13 28MM +3

    FDA Adverse Event
    Injury ·DEPUY INTL., LTD. ¿ REG. # 8010379·Product code LZO·January 4, 2013

    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

    Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024