BEUDAMED
    16 results · 31ms · 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.
    Filters Regulation: Us FDA ×

    HYDROCOIL EMBOLIC SYSTEM-HYDROFRAME MODEL 100931HFM-V, 101243HFM-V, 180827HFM-V, 181139HFM-V, 181445HFM-V, 181850HFM-V

    FDA 510(k)
    FDA Class 2 ·Neurology

    Bur PM2-125 80K Steel Ø2.3 St

    FDA UDI
    Bien-Air Surgery SA·17630055504095·

    Bur PM2-125 80K steel Ø2.3mm sterile

    FDA UDI
    Bien-Air Surgery SA·J00711004540011·

    Digital Analogue 5.5

    FDA UDI
    RP - CONEXOES RESTAURADORAS LTDA·07901059074833·

    WELDON MINI BULLDOG CLAMP

    FDA UDI
    SONTEC INSTRUMENTS, INC.·B09921004540·WELDON MINI BULLDOG CLAMP SERRATED REVERSED JAW

    REZUM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code KNS·December 31, 2025

    DIMEX 2

    FDA 510(k)
    FDA Class 2 ·Dental

    THE ALBERTA LENS SM2, SULFOCON B

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code OZO·March 17, 2020

    LIFEPAK(R) 20E DEFIBRILLATOR/MONITOR

    FDA Adverse Event
    Malfunction ·PHYSIO-CONTROL, INC. - 3015876·Product code MKJ·September 25, 2018

    CAPD DISCONNECT Y SET

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·May 8, 2013

    UNKNOWN_KIE_PRODUCT

    FDA Adverse Event
    Injury ·STRYKER TRAUMA KIEL·Product code HSB·September 19, 2014

    7700

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·May 13, 2011

    CME America T-Syringe Pump - T34 - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through clinically acceptable routes of administration, including intravenous, subcutaneous, percutaneous, intra-arterial, epidural, in close proximity to nerves, and into an intra-operative site (soft tissue/body cavity/surgical wound site).

    FDA Enforcement
    Class II ·Terminated·CME America, LLC·December 9, 2020

    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 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