BEUDAMED
    15 results · 21ms · 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 ×

    VITAL SCIENTIFIC COAGULATION CONTROL,COAGULATION CONTROL LEVEL 1,2,3,QUIKCOAG COAGULATION CONTROL

    FDA 510(k)
    FDA Class 2 ·Hematology

    LINK Instruments - Trial implants and size gauges

    FDA UDI
    WALDEMAR LINK GmbH & Co. KG·04026575408962·Acetabulum prosthesis trial, reusable - Vario-C...

    Intelliguides

    FDA UDI
    Mios Marketing, LLC·G2710420220460·Anterio Lateral Closing Wedge Osteotomy Guide, ...

    Intelliguides

    FDA UDI
    Mios Marketing, LLC·G2710410220460·Anterior Closing Wedge Osteotomy Guide, 22mm x ...

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code LZG·October 12, 2018

    MULTIGAS UNIT, MODEL AG-920RA

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    MODIFICATION TO AUTOMATED NON-INVASIVE BLOOD PRESSURE MONITOR, MODEL BPM-100

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CADD CASSETTE RESERVOIR, 100ML

    FDA Adverse Event
    Malfunction ·SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.·Product code FPA·April 22, 2025

    TITAN TOUCH SCRO ZERO ANG 20CM

    FDA Adverse Event
    Injury ·COLOPLAST A/S·Product code FHW·October 10, 2018

    MECHANICAL (MANUAL) WHEELCHAIR

    FDA Adverse Event
    INVAMEX·Product code IOR·March 26, 2013

    GREENLIGHT ADDSTAT

    FDA Adverse Event
    Malfunction ·AMS, INNOVATION CENTER - SILICON VALLEY·Product code GEX·February 28, 2011

    VICRYL PLUS SURGICAL SUTURE

    FDA Adverse Event
    Malfunction ·ETHICON·Product code GAM·March 31, 2008

    Smiths Medical CADD Medication Cassette Reservoir with flow stop, clamp and female Luer. Non-vented stopper included. 100mL, Product Code 21-7302-24

    FDA Enforcement
    Class II ·Ongoing·ICU Medical Inc.·September 10, 2025

    3T 16ch Flex SPEEDER Coil, Large, NeoCoil Part Number NC046200, Toshiba Medical Systems Model MJAJ-222A. The NeoCoil 3T 16ch Flex SPEEDER Coils are tuned to receive RF frequency corresponding to the proton precession in a 3 tesla magnetic field, which is governed by the Larmor equation. To be used in conjunction with Toshiba 3T Magnetic Resonance Scanners with ODU connectors to produce diagnostic images of the upper and lower extremities, chest, abdomen, pelvis, head, neck and spine that can be interpreted by a trained physician.

    FDA Enforcement
    Class II ·Terminated·NeoCoil, LLC·August 10, 2016

    Daig Livewire Steerable, Product Number 401932; REPROCESSED ELECTROPHYSIOLOGY CATHETER

    FDA Enforcement
    Class II ·Ongoing·Stryker Sustainability Solutions·May 20, 2026