BEUDAMED
    15 results · 21ms · Sources: EU EUDAMED, US FDA

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    GELCLAIR CONCENTRATED ORAL GEL

    FDA 510(k)
    FDA Unclassified ·Unknown

    Diamond D

    FDA UDI
    Keystone Industries·H66810130561·Denture Acrylic SC Light Pwd

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033454251·

    InTess C Cervical Cage System

    FDA UDI
    Kalitec Direct LLC·B07309K01305N0·Cervical Rasp, 14 x 11, 5mm, 0 Degree, No Taper

    SYNCHRON VANCOMYCIN REAGENT

    FDA Adverse Event
    BECKMAN COULTER INC.·Product code LEH·June 10, 2011

    UTERINE MANIPULATOR INJECTOR CANNULA, STERILE, MODEL R 57-450

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

    OVARIAL BIOPSY SET 324102-324108; OVARIAL BIOPSY SET 324200-324202; OVARIAL BIOPSY NEEDLE 32218

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

    QUICK-CORE ULTRASOUND BIOPSY NEEDLE

    FDA Adverse Event
    Injury ·COOK ENDOSCOPY·Product code FCG·September 4, 2018

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·March 1, 2013

    ASR ACETABULAR CUPS 52

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·February 24, 2011

    INTERSTIM II

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·August 15, 2014

    365¿M Lithotripsy Fiber- Reusable; Sure F!ex laser fibers are intended for use in laser-based surgical applications, including, but not limited to endoscopic, laparoscopic and open surgical procedures involving vaporization, ablation, coagulation, hemostasis, excision, resection and incision of soft and cartilaginous tissue and surgical procedures involving vaporization, ablation and fragmentation of calculi (urinary and biliary).

    FDA Enforcement
    Class II ·Terminated·American Medical Systems Innovation Center - Silicon Valley·July 29, 2015

    BIOMET 3i, PROVIDE IMPRESSION COPING KITS, Catalog # PRK484, PRK485, PRK654, and PRK655 BIOMET 3i Restorative Products are intended for use as an accessory to endosseous dental implants for placement in the maxilla and mandible. Provisional Abutments are intended for use as an accessory to endosseous dental implants to support a prosthetic device in a partially or fully edentulous patient. They are intended for use to support a prosthesis in the mandible or maxilla for up to 180 days during endosseous and gingival healing, and are for non-occlusal loading of provisional restorations.

    FDA Enforcement
    Class II ·Terminated·Biomet 3i, LLC·January 13, 2016

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Cardiac Rhythm Management Division·September 10, 2014