BEUDAMED
    15 results · 23ms · 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 ×

    ILUMIEN, Drageonfly OPTIS Imaging Catheter

    FDA 510(k)
    FDA Class 2 ·Radiology

    HHM

    FDA UDI
    Oticon A/S·05707131286123·H160V2 TI, RITE 312 WL DBL HHM

    APEX Revision Knee

    FDA UDI
    Omni Life Science, Inc.·00841690122760·Modular Stem 23mm x 75mm

    DIALYSATE METER, MODEL D-6

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

    STARSHIELD V3 RF TRNT

    FDA 510(k)
    FDA Class 2 ·Radiology

    T:SLIM X2 INSULIN PUMP WITH INTEROPERABLE TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·May 28, 2020

    RADIFOCUS OPTITORQUE

    FDA Adverse Event
    Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DQX·June 13, 2022

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·June 6, 2013

    ADVANTAGE SERIES 26

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FPO·June 10, 2011

    SPDLNK 5.5 TRANS CNTR MED 43-51MM

    FDA Adverse Event
    Injury ·ABBOTT SPINE·Product code KWP·September 3, 2008

    OPTITORQUE ANGIOGRAPHIC CATHETER

    FDA Adverse Event
    Malfunction ·Product code DQO·January 20, 2021

    BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON IND. CIRURGICAS LTDA·Product code JKA·March 13, 2025

    Remel Blood Agar/MacConkey Agar Bi-Plate, REF: R02049

    FDA Enforcement
    Class II ·Terminated·Remel Inc·January 20, 2021

    EDI BZO UNCUT SHEET-CARD, Item No. 100170 These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of drug strips, including Benzodiazepine (BZO). They are used to obtain a visual, qualitative result and are intended for professional and point of care use.

    FDA Enforcement
    Class II ·Terminated·Ameditech Inc·November 25, 2015

    SIGMA Spectrum Infusion Pump, Model/Catalog Number: 35700BAX2

    FDA Enforcement
    Class II ·Ongoing·Baxter Healthcare Corporation·January 28, 2026