BEUDAMED
    23 results · 38ms · 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 ×

    POWDERFREE BLACK NITRILE EXAMINATION GLOVES

    FDA 510(k)
    FDA Class 1 ·General Hospital

    36M - MSHA Miners

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588026206·36M - MSHA Miners

    NA

    FDA UDI
    Stryker Leibinger GmbH & Co. KG·04546540134486·ZYGOMA HOOK

    Temp Fix

    FDA UDI
    Harvest Dental Products, LLC·D870102620·Temp Fix Disc, 98 X 20mm, Shade C1

    Trial Procedure Kit

    FDA UDI
    MEDIVATORS INC.·00677964102219·Trial Procedure Kit

    Endo Carry-On Procedure Kit

    FDA UDI
    MEDIVATORS INC.·00677964104077·Endo Carry-On Procedure Kit

    Zavation

    FDA UDI
    Zavation LLC·00197157007485·ALIF Universal Drill, 20mm

    remanium®

    FDA UDI
    DENTAURUM GmbH & Co.KG·J011102620500·remanium® star Intro-Set

    remanium®

    FDA UDI
    DENTAURUM GmbH & Co.KG·J011102620700·remanium® star SLM powder 10-30 µm

    remanium®

    FDA UDI
    DENTAURUM GmbH & Co.KG·J011102620000·remanium® star CoCr bonding alloy / For furthe...

    SE-200

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

    SURESMILE SYSTEM

    FDA 510(k)
    FDA Class 1 ·Dental

    TRESTLE LUXE¿ Anterior Cervical Plating System, Product code KWQ. 510(k) K102820. The TRESTLE LUXE Anterior Cervical Plating System is a temporary device used to stabilize the cervical spine during bone fusion development. Device implants include a range of plate sizes and bone screws to provide the versatility required for the specific indications noted. Fixation is achieved by means of a rigid plate that is surgically attached to the spine with bone screws. The TRESTLE LUXE Anterior Cervical Plating System is intended for use in the anterior cervical spine (C2-C7). Patients with trauma (including fractures), spondylolisthesis, and pseudoarthrosis, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spinal stenosis, tumors, and failed previous fusion.

    FDA Enforcement
    Class II ·Terminated·Alphatec Spine, Inc.·September 5, 2012

    DUAL COOLER/HEATER

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DWC·May 1, 2013

    PERFORMER INTRODUCER

    FDA Adverse Event
    Injury ·COOK, INC.·Product code DYB·September 11, 2014

    SYNERGY

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·May 23, 2011

    BD NEXIVA¿ CLOSED IV CATHETER SYSTEM

    FDA Adverse Event
    Malfunction ·Product code FOZ·June 25, 2021

    DRIVING CAP/THREADED

    FDA Adverse Event
    Malfunction ·SYNTHES BETTLACH·Product code LXH·October 19, 2016

    BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC)

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON CARIBE LTD.·Product code MDB·October 2, 2022

    CUP: MPACT 01.32.148DH ACETABULAR SHELL Ø48 TWO-HOLES

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LPH·October 28, 2022