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

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    BIO Z CARDIO PROFILE HEMODYNAMIC MONITOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    AFFINITY PIXIE OXYGENATION SYSTEM WITH CARMEDA BIOACTIVE SURFACE OR BALANCE BIOSURFACE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    AT HOME DRUG TEST, MODEL 9063 T

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY (BD)·Product code FPA·March 11, 2024

    BLAKE DRAIN UNKNOWN PRODUCT

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code GBX·March 8, 2018

    OCTRODE

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 10, 2013

    GRANUFLO

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·September 10, 2014

    ACTIVE® INHIBIN A ELISA, 4X96 WELLS

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

    BD PEGASUS BL 22GA X 0.75IN PRN NON-PVC

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU·Product code FOZ·December 3, 2021

    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

    EMBLEM S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A209

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021