BEUDAMED
    12 results · 22ms · Sources: EU EUDAMED, US FDA

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    Terumo Injection Filter Needle (NF-3013RBKE05M)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    IMP,TSV,4.1MM,SBM,11.5

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·January 26, 2023

    IMPL TAPERED SCR-V SBM 3.7MM 3.5MM 10MM

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·January 25, 2023

    SIM

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

    TESCERAFLO A2, MODEL T-21012P; TESCERAFLO A2 OPAQUE, MODEL T-210120P

    FDA 510(k)
    FDA Class 2 ·Dental

    IMP,TSV,4.1MM,SBM,11.5

    FDA Adverse Event
    Malfunction ·ZIMMER DENTAL·Product code DZE·October 25, 2021

    IMP,TSV,4.1MM,SBM,11.5

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·March 29, 2024

    MRHK BUMPER INSERT - NEUTRAL

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS-MAHWAH·Product code KRO·May 19, 2026

    EXTERNAL PADDLES

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·October 15, 2014

    HEARTSTART MRX

    FDA Adverse Event
    Malfunction ·PHILIPS HEALTHCARE - ANDOVER·Product code MKJ·July 21, 2011

    LOCK-CAP ONE-STEP F/MATRIX 5.5 TAN

    FDA Adverse Event
    Injury ·SYNTHES BRANDYWINE·Product code NKB·July 17, 2013

    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