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

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    CRE FIXED WIRE BALLON DILATION CATHETER

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

    AEQUALIS ASCEND MODULAR ANATOMIC SHOULDER SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SHERPA MOBILITY SYSTEM (MANUAL WHEELCHAIR)

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    ANKLE ARTHRODESIS NAIL, LEFT 10X150MM

    FDA Adverse Event
    Injury ·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·July 8, 2010

    TBD

    FDA Adverse Event
    Malfunction ·Product code KOD·April 5, 2018

    ATLANTIS? 018

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - FREMONT (SUD)·Product code ITX·May 21, 2013

    SENSIA DR

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL, INC.·Product code NVZ·June 14, 2011

    VERSACARE

    FDA Adverse Event
    Malfunction ·HILL-ROM RITTER·Product code FNL·August 20, 2008

    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

    ATLAS GOLD

    FDA Adverse Event
    Malfunction ·BARD PERIPHERAL VASCULAR, INC.·Product code DQY·December 18, 2023

    ATLAS GOLD

    FDA Adverse Event
    Malfunction ·BARD PERIPHERAL VASCULAR, INC.·Product code DQY·December 7, 2023

    ATLAS GOLD

    FDA Adverse Event
    Malfunction ·BARD PERIPHERAL VASCULAR, INC.·Product code DQY·November 14, 2023

    30" (76 cm) Appx. 3.3 ml, Admin Set w/ 20 Drop Admin Set w/ Integrated ChemoLock Port Drip Chamber, ChemoLock, Hanger, Item No. CL3511 sterile devices intended for the infusion and withdrawal of fluids.

    FDA Enforcement
    Class II ·Terminated·ICU Medical, Inc.·April 6, 2016

    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

    DePuy Synthes Craniomaxillofacial Distraction System (AB Distractor Bodies and BC Distractor Bodies)

    FDA Enforcement
    Class I ·Terminated·Synthes, Inc.·August 27, 2014

    HealthLink***BIOPSY PUNCHES*** Disposable manual instrument for skin biopsy.

    FDA Enforcement
    Class II ·Terminated·Clorox Healthcare Holdings, LLC (dba HealthLink)·July 10, 2013