BEUDAMED
    11 results · 27ms · 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.

    LAP LOOP

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

    PROSTHESIS - UNIVERSAL TITANIUM PROSTHESIS

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED INC.·Product code ETA·February 19, 2016

    TITANIUM MIDDLE EAR PROSTHESES

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

    MODIFICATION TO HERMES OPERATING ROOM CONTROL CENTER

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

    BI-EXT SET 15CM SMALL BORE SPIN NUT

    FDA Adverse Event
    Malfunction ·Product code FPA·July 9, 2021

    DIDECO COMPACTFLO EVOLUTION OXYGENATOR

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA·Product code DTZ·January 15, 2016

    MECHANICAL (MANUAL) WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE SUZHOU·Product code IOR·May 3, 2013

    COAGUCHEK ® XS SYSTEM

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code GJS·September 16, 2014

    SURGICAL SUCKER/SUMP SET

    FDA Adverse Event
    Malfunction ·NOVOSCI CORP.·Product code DTS·April 11, 2011

    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

    Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Left, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-22, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-23, c) 44, 47, 50, 53 head, Large, Item Number 314-13-24, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-25; Shoulder Arthroplasty

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