BEUDAMED
    13 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 ×

    Pulse Oximeter(Model OHT60,OXH78)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Oticon

    FDA UDI
    Sbo Hearing A/S·05714464029693·OTICON MORE 2 MINIRITE T C091

    NA

    FDA UDI
    Stryker Leibinger GmbH & Co. KG·04546540177308·BIPOLAR FORCEPS

    devemed

    FDA UDI
    devemed GmbH·04061644030910·Anatomical tweezers, micro diamond coated | 0.6...

    SURESTEP

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code CFR·February 21, 2001

    SINGLE ENERGY (SE) FEMUR EXAMS

    FDA 510(k)
    FDA Class 2 ·Radiology

    SOFT-CELL DUAL LUMEN CATHETERS

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

    3DKNEE

    FDA Adverse Event
    Other ·ENCORE MEDICAL, L.P.·Product code HSH·November 7, 2008

    ACCESS® 2 IMMUNOASSAY SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code JJE·September 1, 2011

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·July 16, 2013

    i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300

    FDA Enforcement
    Class II ·Ongoing·Abbott Point Of Care Inc.·September 24, 2025

    i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300

    FDA Recall
    Open, Classified ·Abbott Point Of Care Inc.·Product code CHL·August 21, 2025

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025