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

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    Agnes

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

    Compressor Wrist Support

    FDA UDI
    MEDICAL SPECIALTIES INCORPORATED·00802357238057·

    LAERDAL PAEDIATRIC POCKET MASK, MODEL 820050

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    E-Z CHEK BLOOD LEAK TEST STRIPS

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

    BD BBL¿ TRYPTICASE¿ SOY AGAR (SOYBEAN-CASEIN DIGEST AGAR)

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code JSG·December 7, 2021

    1710034-2017-00013

    FDA Adverse Event
    Malfunction ·January 23, 2017

    TENDRIL ST

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·November 10, 2008

    BI-LEVEL/CPAP ADULT BREATHING CIRCUIT

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·August 25, 2011

    RESTORE ULTRA

    FDA Adverse Event
    Malfunction ·MEDTRONIC NEUROMODULATION·Product code LGW·July 12, 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

    SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels

    FDA Enforcement
    Class I ·Terminated·Zimmer Biomet, Inc.·November 7, 2018

    Multi-parameter Command Module, Model 91496, optioned with Masimo or Nellcor

    FDA Enforcement
    Class II ·Ongoing·Spacelabs Healthcare, Inc.·April 15, 2026