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

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    Coag-Sense Prothrombin Time (PT) / INR Monitoring Device

    FDA 510(k)
    FDA Class 2 ·Hematology

    MobileLink Acetabular Cup System

    FDA UDI
    WALDEMAR LINK GmbH & Co. KG·04026575177110·Standard UHMWPE Insert - neutral

    MobileLink Acetabular Cup System

    FDA UDI
    WALDEMAR LINK GmbH & Co. KG·04026575177103·Standard UHMWPE Insert - neutral

    VASCULAR POSITIONING SYSTEM TM (VPS TM SYSTEM) STYLET

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    16CH AI BREAST COILS 1.5 T AND 3 T

    FDA 510(k)
    FDA Class 2 ·Radiology

    LOCKING SCREW, FULLY THREADED 5X50 MM

    FDA Adverse Event
    Injury ·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·September 14, 2010

    LOCKING SCREW, FULLY THREADED 5X50MM

    FDA Adverse Event
    Malfunction ·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·August 24, 2010

    MICROMAX MOTOR ASSY

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code ERL·October 17, 2014

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·June 21, 2013

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 28, 2011

    VERSACROSS ACCESS SOLUTION

    FDA Adverse Event
    Injury ·BAYLIS MEDICAL COMPANY INC.·Product code DYB·April 20, 2023

    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