BEUDAMED
    12 results · 20ms · 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 ×

    INNO SLA SUBMERGED IMPLANT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    Stellen Medical, LLC

    FDA registration
    Stellen Medical, LLC·3 products·🇺🇸 United States

    SYRINGE 0.5ML 31GA 8MM UFII 10BAG 500CS

    FDA Adverse Event
    Malfunction ·BD MEDICAL - DIABETES CARE·Product code FMF·November 19, 2020

    OSOM C. DIFFICILE TOXIN A/B TEST

    FDA 510(k)
    FDA Class 1 ·Microbiology

    PERSONNA PLUS SAFETY SCALPEL SYSTEM

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·June 4, 2024

    FINELINE II

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code DTB·October 1, 2014

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    FDA Adverse Event
    BAXTER HEALTHCARE·Product code FKX·May 29, 2013

    FLEXI-SEAL SIGNAL FMS

    FDA Adverse Event
    Death ·CONVATEC·Product code KNT·June 14, 2011

    XVWEB

    FDA Adverse Event
    Injury ·PLANET DDS·Product code LLZ·March 13, 2025

    SECOND OPINION

    FDA Adverse Event
    Injury ·PEARL INC.·Product code MYN·March 13, 2025

    Ultraview SL Command Modules, Model 91496, with the Masimo SpO2 PCBA, PN: 010-1636-02. The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare Inc·May 13, 2015