BEUDAMED
    37 results · 20ms · 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 ×

    APEX-LNK ACETABULAR INSERT, E, APEX-LNK ACETABULAR INSERT, F, APEX-LNK

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DEBAKEY NEONATAL CLAMP

    FDA UDI
    SONTEC INSTRUMENTS, INC.·B09921005550·DEBAKEY NEONATAL CLAMP ANGLED JAW STRAIGHT SHANK

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450258545·

    HS Dia.Burr,coarse,Ø4.0x70,50k

    FDA UDI
    Bien-Air Surgery SA·07630055506962·

    IN-OVATION® C

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807K100552821·IN-OVATION® C EURO 022 U 5-5/L 3-3 CS-BC HK

    IN-OVATION® C

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807K100552811·IN-OVATION® C EURO 022 U5-5/L3-3 CS HK

    N/A

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807K100551921·In-Ovation C/R RNC/BASE/EURO 018 UL5-5 CS-BC HK

    IN-OVATION® C

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807K100551821·IN-OVATION® C EURO 018 U5-5/L3-3 CS-BC HK

    IN-OVATION® C

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807K100551811·IN-OVATION® C EURO 018 U5-5/L3-3 CS HK

    QUANTA SYSTEM S.P.A.

    FDA Adverse Event
    Malfunction ·QUANTA SYSTEM, S.P.A.·Product code GEX·December 21, 2012

    SPECTRA WAVEWRITER

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·February 14, 2023

    TEKMEDIC POWDERED SINGLE-USE LATEX PATIENT EXAMINATION GLOVES WITH PROTEIN & POWDER LABEL CLAIM CONTAINS 70MGM OR LESS O

    FDA 510(k)
    FDA Class 1 ·General Hospital

    JAX

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    EXTENSION, DUAL 4 CHANNEL 30CM

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·September 24, 2015

    UNICEL® DXC 600 PRO SYNCHRON® ACCESS® CLINICAL SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER·Product code MZV·May 8, 2013

    TM ACETABULAR CEMENTED POLYETHYLENE LINER

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code KWZ·May 17, 2011

    CUP: MPACT ACETABULAR SHELL Ø56 MULTI-HOLE

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LPH·March 1, 2022

    Powered Mobility Offers Versatility (M¿V)TM Chair The Powered MOV Chair models EMS, EMS24, HHC, and INO Powered MOV Chair, enable two operators to transport a seated patient weighing up to 500 Ibs up or down stairs. Key features include infinite positioning system, thermal protection system, and locking casters. In addition to the aforementioned features, the battery powered track reduces operator effort and risk of back injury while transporting a patient up or down a set of stairs.

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·August 29, 2012

    TherMax Blood Warmer Unit

    FDA Enforcement
    Class II ·Terminated·Baxter Healthcare Corporation·November 6, 2019

    HA FlexTrak II-Patient transport functionality to transport the patient from the preparation area to the MR system, Product Number: 989710008732

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·June 12, 2024