BEUDAMED
    10 results · 31ms · Sources: EU EUDAMED, US FDA

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    Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Strip, Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Cassette, Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Midstream

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    RIGIDFIX

    FDA UDI
    DEPUY MITEK, LLC·10886705003211·RIGIDFIX TIBIAL ROD Soft Tissue Only 8mm, 20-90...

    SLEEPBITE

    FDA 510(k)
    FDA Class 2 ·Dental

    THE SHERLOCK 3CG TIP CONFIRMATION SYSTEM (TCS)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    KNIGHTSTAR 330

    FDA Adverse Event
    Malfunction ·NELLCOR PURITAN BENNETT·Product code CBK·October 22, 2008

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE·Product code KDJ·August 17, 2011

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·July 9, 2013

    MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.

    FDA Recall
    Open, Classified ·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025

    MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.

    FDA Enforcement
    Class I ·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025

    Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEM MRI S-ICD Pulse Generator

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 25, 2019