BEUDAMED
    11 results · 22ms · Sources: EU EUDAMED, US FDA

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    FDA 510(k)
    FDA Class 2 ·Radiology

    ACCUSCULPT II LASER SYSTEM

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

    EMS AIR-FLOW MASTER PIEZON

    FDA 510(k)
    FDA Class 2 ·Dental

    STERNALOCK BLU SYSTEM BLADE, STERNALOCK POWERDRIVER

    FDA Adverse Event
    Malfunction ·BIOMET MICROFIXATION·Product code HRS·January 10, 2019

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·May 14, 2013

    530G INSULIN PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code OZO·September 23, 2014

    BLAZER II XP

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFICTEMPERATE ABLATION CATHETER·Product code LPB·May 20, 2011

    UNKNOWN

    FDA Adverse Event
    Malfunction ·WILLIAM COOK EUROPE·Product code DTK·December 18, 2015

    Ultrasound Video Gastroscope, Model EG-3870UTK. The product is intended to be used in combination with the ultrasound scanning unit made by Hitachi Medical Corporation, and the PENTAX Medical video processor to provide images for observation, diagnosis, imaging, or therapy of the upper gastrointestinal tract from esophagus through duodenum.

    FDA Enforcement
    Class II ·Terminated·Pentax of America Inc·August 30, 2017

    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

    Smiths Medical Medfusion Model 3500 Syringe pumps, Item Numbers: a) 3500 b) 3500-0600-00 c) 3500-0600-01 d) 3500-0600-249 e) 3500-0600-50 f) 3500-0600-51 g) 3500-0600-82 h) 3500-306 i) 3500-402 j) 3500-414 k) 3500-415 l) 3500-500 m) 3500E n) 3500VX-306 o) 3500VX-500

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD Inc.·April 24, 2024