BEUDAMED
    16 results · 20ms · Sources: EU EUDAMED, US FDA

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    RAPIDD HIGHSPEED DENTAL HANDPIECE

    FDA 510(k)
    FDA Class 1 ·Dental

    TruForm

    FDA UDI
    Rmo, Inc.·00885797099938·R&L MAX MOLAR 214 BDS W/O LUGS

    Minit®

    FDA UDI
    ZIMMER SPINE, INC.·00889024333406·

    NorthStar

    FDA UDI
    Seaspine Orthopedics Corporation·10889981195977·Poly. Screw, 3.5mm x 18mm

    LIFEPAK® 12 defibrillator/monitor

    FDA UDI
    PHYSIO-CONTROL, INC.·00885074857961·LP12AABCBBBACABBAABAAAAALP12 MONITOR-DEFIB

    GRADIA

    FDA 510(k)
    FDA Class 2 ·Dental

    MACROPRO GEL

    FDA 510(k)
    FDA Unclassified ·Unknown

    AUTOSOFT 90

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·September 24, 2024

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·January 5, 2026

    2520274-2013-10149

    FDA Adverse Event
    Malfunction ·Product code MJO·February 28, 2013

    MAVERICK2 BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - GALWAY·Product code LOX·March 1, 2011

    BG3000-G-UNKNOWN CONFIGURATION

    FDA Adverse Event
    Other ·CRYOLIFE, INC.·Product code MFI·February 18, 2008

    COPAN UTM

    FDA Adverse Event
    Malfunction ·COPAN ITALIA SPA·Product code JSM·June 5, 2020

    smiths medical portex Venn Reusable Tracheal Tube Introducer, 15Ch x 60cm, REF 14-504-17 and REF 14-504-17JP

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD, Inc.·December 4, 2024

    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