BEUDAMED
    13 results · 37ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

    ATRIUM MEDICAL CORPORATION CLEARWAY PTFE BALLOON CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Medical Facets NC

    FDA UDI
    MEDICAL FACETS NC LLC·M933MDF20026270·3.0mm Cannulated Screw, Self-Drilling, Short Th...

    SCANDINAVIAN IVF SCIENCES AB, HYBASE-1

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    TRIFIX SPINAL FIXATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PROFILE NT SERIES 29 .167/.04 21MM

    FDA Adverse Event
    Malfunction ·TULSA DENTAL PRODUCTS LLC·Product code EKS·April 3, 2020

    3.5 X 15M STANDARD SELF-DRILLING SCREW

    FDA Adverse Event
    Injury ·PRECISION SPINE, INC·Product code OVE·March 6, 2015

    MARATHON MICRO CATHETER

    FDA Adverse Event
    Injury ·EV3 NEUROVASCULAR·Product code DYG·March 13, 2013

    DIMENSION® CLINICAL CHEMISTRY SYSTEM

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS INC - BROOKFIELD·Product code MMI·February 28, 2011

    RESPIRATORY HUMIDIFIER

    FDA Adverse Event
    Death ·FISHER & PAYKEL HEALTHCARE, LTD.·Product code BTT·February 27, 2008

    INFLOW TUBING FMS VUE 24PK

    FDA Adverse Event
    Malfunction ·DEPUY MITEK LLC US·Product code HRX·December 19, 2023

    Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular tachyarrhythmias.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·March 27, 2013

    1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025

    CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: 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