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

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    DNE EXTERNAL FIXATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    JOBST forMen Casual

    FDA UDI
    BSN MEDICAL, INC.·00035664131067·FOR MEN CASUAL 15-20 MM HG KNEE HIGH CLOSED TOE...

    Cranial Fusion

    FDA UDI
    Life Spine, Inc.·00190837085186·

    CHLORASHIELD TM ANTIMICROBIAL DRESSING

    FDA 510(k)
    FDA Unclassified ·Unknown

    2 PIECE MODULAR HIP STEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ONE TOUCH PROFILE

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code CFR·July 24, 2002

    OT ULTRA2 METER

    FDA Adverse Event
    Injury ·LIFESCAN, INC.·Product code NBW·October 14, 2010

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code MDS·August 20, 2010

    DIGITAL RADIOGRAPHY CXDI

    FDA Adverse Event
    Malfunction ·CANON, INC.·Product code MQB·December 22, 2019

    DIGITAL RADIOGRAPHY CXDI

    FDA Adverse Event
    Malfunction ·CANON, INC.·Product code MQB·December 22, 2019

    DIGITAL RADIOGRAPHY CXDI

    FDA Adverse Event
    Malfunction ·CANON, INC.·Product code MQB·December 22, 2019

    HEARTSTART FRX

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·May 9, 2013

    IMPAX CV OUTBOUND (RESULTS MANAGEMENT 2.08)

    FDA Adverse Event
    Malfunction ·AGFA HEALTHCARE CORP.·Product code LLZ·February 28, 2014

    UNKNOWN DEPUY ASR HIP

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·May 20, 2011

    TRUE METRIX

    FDA Adverse Event
    Injury ·TRIVIDIA HEALTH INC·Product code NBW·February 1, 2023

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS NEONATAL TRACH TUBE , Product Code/List Number/Item Code 67N025; b) TTS NEONATAL TRACH TUBE , Product Code/List Number/Item Code 67N030; c) TTS NEONATAL TRACH TUBE , Product Code/List Number/Item Code 67N035

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·September 4, 2024

    Accu-Chek FlexLink 1 infusion set; 8/110; Ref number 04540832001. (Distributed outside of the U.S. only).

    FDA Recall
    Terminated ·Disetronic Medical Systems, Inc.·Product code LZG·March 31, 2006

    Azurion 3 M12; Catalog numbers: (1) 722063, (2) 722221.

    FDA Enforcement
    Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025

    Azurion 3 M15; Catalog numbers: (1) 722064, (2) 722222 (3) 722280(OUS ONLY).

    FDA Enforcement
    Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025

    EMBLEM S-ICD Model A209

    FDA Enforcement
    Class I ·Terminated·Boston Scientific Corporation·February 17, 2021