BEUDAMED
    16 results · 19ms · 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.

    CONCENTRIC RETRIEVER, MODEL 90030

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Kirschner wire

    FDA UDI
    ADLER ORTHO SPA·08054752863408·TIPLESS KIRSHNER WIRE D2mm L=150mm

    Custom Procedure Kit

    FDA UDI
    MEDIVATORS INC.·40677964023222·Endo Carry-on Procedure Kit includes Olympus 5-...

    Navagio

    FDA UDI
    Kalitec Direct LLC·B07330K0134100·Trial, TLIF, 27L OB STR 7Deg, 10mm

    AUTOSOFT XC

    FDA Adverse Event
    Malfunction ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·May 22, 2025

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE INC.·Product code LZG·November 6, 2014

    PHORESOR MODEL PM2000

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    SYNCHRON SYSTEMS ALCOHOL REAGENT AND CALIBRATORS

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    STEM EXTRACTOR F/GUIDE BAR

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code HWB·February 28, 2013

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·March 1, 2011

    ROTALINK PLUS

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC·Product code MCX·February 21, 2008

    EVOLUT FX DCS

    FDA Adverse Event
    Malfunction ·MEDTRONIC HEART VALVES DIVISION·Product code NPT·June 25, 2025

    Gambro Cartridge Blood Set, 003410-510, is intended for single use in a hemodialysis treatment using the Phoenix and Centry system 3 Dialysis Delivery Systems.

    FDA Recall
    Terminated ·Gambro Renal Products, Inc.·Product code FJK·May 2, 2008

    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

    Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; 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