BEUDAMED
    14 results · 27ms · Sources: EU EUDAMED, US FDA

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    Spinal Inner Fixation System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Pinnacle®

    FDA UDI
    Ortho Organizers, Inc.·00190707111939·Pinnacle .022 MC U/L 5x5 Hks 345, OS Pad U/L 4/...

    Pinnacle

    FDA UDI
    ORTHO TECHNOLOGY, INC.·00190730009968·Pinnacle 022 MC U/L 5x5 Hks 345, OS Pad U/L 4/5...

    Votion

    FDA UDI
    ORTHO TECHNOLOGY, INC.·00190730008138·Votion 022 MC U/L 5x5 Hks 345, OS Pad U/L 4/5 SPK

    Votion®

    FDA UDI
    Ortho Organizers, Inc.·00190707113827·Votion .022 MC U/L 5x5 Hks 345, OS Pad U/L 4/5 SPK

    NARKOMED MRI-2 ANESTHESIA SYSTEM, MODEL NM-MRI-2

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    NEXTRA TI HAMMERTOE CORRECTION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 13, 2025

    PUMP MMT-722LNAS PRDGM INS SK EN ML

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code LZG·November 3, 2008

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·August 24, 2011

    CCU BED WITH SCALE

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·July 3, 2013

    TIBIA FIXED CEMENTED LEFT SIZE D STEM EXTENSION

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JWH·May 16, 2023

    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

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025