BEUDAMED
    17 results · 29ms · Sources: EU EUDAMED, US FDA

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    ESENSOR WARFARIN SENSITIVITY SALIVA TEST

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    JOBST Men's Dress

    FDA UDI
    BSN MEDICAL, INC.·00035664107864·MEN'S DRESS 8-15 MM HG KNEE HIGH CLOSED TOE LAR...

    Marina Medical

    FDA UDI
    MARINA MEDICAL INSTRUMENTS, INC.·00840306818349·AXS Straight Rack Attachment

    REZUM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code KNS·April 23, 2024

    ULNAR HEAD IMPLANT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MICROTHERMX MICROWAVE ABLATION SYSTEM, MODELS MTX-180 OR MTX

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

    TOSHIBA Kalare Diagnostic X-Ray System K110785

    FDA Recall
    Terminated ·Toshiba American Medical Systems Inc·Product code JAA·April 3, 2013

    EON MINI

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 9, 2013

    PUREPOINT

    FDA Adverse Event
    Malfunction ·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQF·September 16, 2014

    UNICEL® DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code JJE·June 1, 2011

    TOSHIBA Kalare Diagnostic X-Ray System K110785

    FDA Enforcement
    Class II ·Terminated·Toshiba American Medical Systems Inc·July 17, 2013

    SLEEK OTW PTA CATHETER

    FDA Adverse Event
    Injury ·CLEARSTREAM TECHNOLOGIES LTD.·Product code DQY·December 13, 2023

    PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code FTL·August 20, 2019

    PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code FTL·August 20, 2019

    INSTAT - Agent, Absorbable Hemostatic, Collagen Based INSTAT MCH is recommended for use in surgical procedures (other than Urological and Ophthalmological surgery) as an adjunct to hemostatis when control of bleeding by ligature or conventional procedures is ineffective or impractical.

    FDA Enforcement
    Class II ·Terminated·Integra LifeSciences Corporation·May 22, 2013

    Video Duodenoscope

    FDA Enforcement
    Class II ·Terminated·Pentax Medical Company·June 8, 2016

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024