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

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    CapLOX II/TowerLOX Pedicle Screw System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    K121116

    FDA UDI
    Life Spine, Inc.·00190837016029·

    DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion System

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00643169502246·INTERBODY 2151116 SMALL - 6 DEG 16MM

    Plateau-X Spacer System

    FDA UDI
    Life Spine, Inc.·00190837016043·

    Plateau-X Spacer System

    FDA UDI
    Life Spine, Inc.·00190837016258·

    POUR-PLUS

    FDA UDI
    Denplus Inc·D8451151116·POUR-PLUS, ORI, 454 g

    New Image

    FDA UDI
    HOLLISTER INCORPORATED·00610075073061·2-Piece Ostomy Skin Barrier, CeraPlus

    AGC Tradition Knee System

    FDA UDI
    Biomet Orthopedics, LLC·00880304241138·

    ProLift Expandable Spacer System

    FDA UDI
    Life Spine, Inc.·00190837065652·

    TALOS® HA PEEK IBF

    FDA UDI
    MEDITECH SPINE, LLC·B167321511160·

    HI-TORQUE PILOT 50 AND 150 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, HI-TORQUE WHISPER LS AND MS GUIDE WIRE WITH

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MODEL TL-560 POWER SCOOTER

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Back up batteries in Ventilators labeled as the following: a. CARESCAPE R860 Ventilators (K142679) b. ENGSTROM (K111116) c. ENGSTROM Carestation (K111116) d. ENGSTROM PRO (K111116)

    FDA Recall
    Open, Classified ·GE Healthcare, LLC·Product code CBK·April 18, 2022

    AMBI CHSP 6SL 140MM 130D

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code KTT·November 13, 2015

    Back up batteries in Ventilators labeled as the following: a. CARESCAPE R860 Ventilators (K142679) b. ENGSTROM (K111116) c. ENGSTROM Carestation (K111116) d. ENGSTROM PRO (K111116)

    FDA Enforcement
    Class I ·Ongoing·GE Healthcare, LLC·June 15, 2022

    GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 4/10 MM LEFT

    FDA Adverse Event
    Malfunction ·MEDACTA INTERNATIONAL SA·Product code JWH·November 2, 2016

    MAGEC SPINAL BRACING AND DISTRACTION SYSTEM

    FDA Adverse Event
    Injury ·NUVASIVE SPECIALIZED ORTHOPEDICS, INC.·Product code PGN·April 5, 2019

    ISOFLEX OPTIM LEAD

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC. CRMD·Product code DTB·January 13, 2014

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 6, 2013

    VERSACARE

    FDA Adverse Event
    Malfunction ·HILL-ROM RITTER·Product code FNL·September 9, 2008