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

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    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

    RAYSTATION VERSION 1.0

    FDA 510(k)
    FDA Class 2 ·Radiology

    HS Dia.Burr,coarse,Ø2.7x70,50k

    FDA UDI
    Bien-Air Surgery SA·07630055506931·

    IN-OVATION® C

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807H100552801·IN-OVATION® C EURO 022/U5 UNIV -7T 0A

    microTargeting™ Multi-Oblique Tool Guide

    FDA UDI
    FHC, INC.·00873263005521·Multi-Oblique Platform 2.4mm AdTech Bolt Guide

    QUANTA SYSTEM S.P.A.

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

    SIRONA CAD/CAM SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    CG-900P FETAL/MATERNAL MONITOR

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

    COULTER® LH 750 HEMATOLOGY ANALYZER

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

    ZIMMER UNICOMPARTMENTAL FEMORAL COMPONENT

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

    BD VACUTAINER PUSH BUTTON BLOOD COLLECTION SET

    FDA Adverse Event
    Malfunction ·Product code JKA·August 5, 2008

    ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code NKB·January 18, 2016

    PEDICSCR MATRIX 5.5 POLYAXIAL Ø6 PREASSM

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code HWC·June 7, 2013

    LATITUDE ELBOW ANATOMIC HUMERAL SPOOL SZ PETIT+ SIDE GAUCHE

    FDA Adverse Event
    Injury ·TORNIER INC·Product code JDC·May 7, 2024

    5.5MM TI CURVED ROD 45MM

    FDA Adverse Event
    Injury ·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code NKB·February 6, 2020

    Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.

    FDA Enforcement
    Class II ·Terminated·Belmont Instrument Corporation·October 24, 2012

    CME America T-Syringe Pump - T34 - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through clinically acceptable routes of administration, including intravenous, subcutaneous, percutaneous, intra-arterial, epidural, in close proximity to nerves, and into an intra-operative site (soft tissue/body cavity/surgical wound site).

    FDA Enforcement
    Class II ·Terminated·CME America, LLC·December 9, 2020

    TRULIANT Knee System including TRULIANT Tibial Inserts, also labeled as the following: a. TRULIANT CR Tibial Inserts; b. TRULIANT CR Slope + Tibial Inserts; c. TRULIANT CR Slope ++ Tibial Inserts; d. TRULIANT CRC Tibial Inserts; e. TRULIANT PS Tibial Inserts; f. TRULIANT PSC Tibial Inserts. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021