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

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    AUDICOR CPAM (CARDIOPULMONARY AMBULATORY MONITOR)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    KSEA UNIVERSAL LAPAROMAT LAPAROSCOPIC SUCTION AND IRRIGATION PUMP

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

    MERIT EMBOLECTOMY CATHETER MODEL ASAP100

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    TELAMON FUSION DEVICE

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK·Product code MAX·August 5, 2016

    TELAMON® FUSION DEVICE

    FDA Adverse Event
    Injury ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code MAX·August 3, 2012

    TELAMON® FUSION DEVICE

    FDA Adverse Event
    Injury ·MSD DEGGENDORF MFG·Product code MAX·August 3, 2012

    TAMPAX RADIANT TAMPON UNSCENTED, ABSORBENCY UNKNOWN

    FDA Adverse Event
    Malfunction ·TAMBRANDS MANUFACTURING, INC·Product code HEB·March 10, 2021

    TAMPAX RADIANT TAMPON UNSCENTED, ABSORBENCY UNKNOWN

    FDA Adverse Event
    Malfunction ·TAMBRANDS MANUFACTURING, INC·Product code HEB·March 3, 2021

    SERVO-I

    FDA Adverse Event
    Injury ·MAQUET CRITICAL CARE AB·Product code CBK·May 26, 2011

    HOMECHOICE PRO

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·May 14, 2013

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·September 23, 2014

    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