BEUDAMED
    15 results · 19ms · Sources: EU EUDAMED, US FDA

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    DIAMOND ALOE VERA, STERILE

    FDA 510(k)
    FDA Unclassified ·Unknown

    ODYSSEY®

    FDA UDI
    Microport Orthopedics Inc.·M684K00126661·

    Alteon

    FDA UDI
    Exactech, Inc.·10885862630292·Curved Modular Rasp

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450182239·

    TC-PLUS SOLUTION KNEE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MODIFICATION TO INTUITIVE SURGICAL STEREO VIEW ENDOSCOPIC SYSTEM

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

    LUMA ARCH

    FDA Adverse Event
    Injury ·LUMALITE, INC.·Product code EEG·July 6, 2004

    Span-America

    FDA UDI
    SPAN-AMERICA MEDICAL SYSTEMS, INC.·H93300266600000·ZIMMER CAST ELEVATOR 6/CS

    VERSAFITCUP DM DOUBLE MOBILITY HC LINER 50/28

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code MEH·May 17, 2021

    ATLAS MONITOR

    FDA Adverse Event
    Malfunction ·WELCH ALLYN PROTOCOL, INC.·Product code DQA·February 13, 2013

    LIFEVEST WCD 3100 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·February 9, 2011

    ACCU-CHEK AVIVA

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code NBW·February 8, 2008

    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