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

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    VAULT-C INTERVERTEBRAL BODY FUSION DEVICE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    NexxZr™ T / D-100-22-NT-A300-SD

    FDA UDI
    SAGEMAX BIOCERAMICS, INC·00842271112392·

    ihcDirect® CD20 Ab

    FDA UDI
    NOVODIAX, INC.·00850000596061·Clone R272

    ihcDirect® CD20 Ab

    FDA UDI
    NOVODIAX, INC.·00850000596078·Clone R272

    ihcDirect® CD20 Ab Conjugate 15mL

    FDA UDI
    NOVODIAX, INC.·00850030934543·Clone R272

    ihcDirect® CD20 Ab Conjugate 5mL

    FDA UDI
    NOVODIAX, INC.·00850030934536·Clone R272

    PEAK PULSAR II GENERATOR MODEL PS100-102

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    BTG SMARTEST GLUCOSE TEST SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    TSRH SPINAL SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDIC, INC·Product code KWP·December 18, 2014

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 29, 2013

    ASKU

    FDA Adverse Event
    Injury ·MEDTRONIC MILACA INC.·Product code DTE·June 16, 2011

    TELIGEN

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code LWP·October 1, 2014

    HLM TUBING SET W/SOFTLINE COATING

    FDA Adverse Event
    Injury ·MAQUET CARDIOPULMONARY AG·Product code DTZ·November 18, 2015

    HLM TUBING SET W/SOFTLINE COATING

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOPULMONARY AG·Product code DTZ·June 3, 2016

    PLATE, FIXATION, BONE

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code HRS·December 22, 2022

    HLM TUBING SET W/BIOLINE COATING

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOPULMONARY AG·Product code DTZ·August 2, 2016

    DeRoyal AMG Suction Connector Tubing REF: 71-2083, 71-C506, 71-C510, 71-C512, 71-C520, Tubing is intended for fluid movement

    FDA Enforcement
    Class II ·Ongoing·DeRoyal Industries Inc·February 26, 2025

    Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-01-12, b) Medium, Item Number 314-01-13, c) Large, Item Number 314-01-14, Shoulder Arthroplasty

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