BEUDAMED
    15 results · 20ms · Sources: EU EUDAMED, US FDA

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    IQvitals Zone

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Oticon

    FDA UDI
    Oticon A/S·05707131305367·SENSEI PRO, BTE 312 WL 75 AQM

    HAcancellous™ PEEK-C

    FDA UDI
    INNO Holdings, Inc.·M711591619090·HAcancellous PEEK-C, 16L x 19W x 9H x 8°, HA PE...

    Cadet Cervical Cage

    FDA UDI
    VALORUS SPINE LLC·00811771034381·Cadet Cervical Cage, 16mm x 19mm x 09mm, 7° Lor...

    Cadet Cervical Cage

    FDA UDI
    VALORUS SPINE LLC·00811771033759·Cadet Cervical Cage, 16mm x 19mm x 09mm, Non-Lo...

    HIGHLAND BEAM DELIVERY SYSTEM, MODEL 3-099-002-00-00

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    EXACTECH EQUINOXE, PLATFORM FRACTURE STEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    EQUINOXE

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code KWT·July 2, 2019

    VITEK® 2 AST-ST01 TEST KIT

    FDA Adverse Event
    Malfunction ·BIOMERIEUX, INC·Product code LON·October 24, 2017

    PARADIGM INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 10, 2014

    IMPAX CV REPORTING

    FDA Adverse Event
    Malfunction ·AGFA HEALTHCARE CORP.·Product code LLZ·June 11, 2013

    SIGMA STAB GVF INS 4 10MM

    FDA Adverse Event
    Injury ·DEPUY RAYNHAM·Product code JWH·July 11, 2011

    INSPIRE 8F DUAL

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA·Product code DTN·January 9, 2026

    INSPIRE 6 HOLLOW FIBER OXYGENATOR W/ INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RES

    FDA Adverse Event
    SORIN GROUP ITALIA S.R.L.·Product code DTZ·December 7, 2016

    cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018