BEUDAMED
    17 results · 24ms · 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 ×

    MTA2 ROOT AND PULP MATERIALS

    FDA 510(k)
    FDA Class 2 ·Dental

    ASI DEIONIZER & CARBON EXCHANGE SERVICE FOR HEMODIALYSIS

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

    ASCENSION SILLICONE MCP

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CELL-DYN RUBY ANALYZER

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS DIVISION·Product code GKZ·May 21, 2013

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·September 26, 2014

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 14, 2011

    BD INSYTE AUTOGUARD

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·June 20, 2025

    INSTINCT JAVA SCREW, UNKNOWN SIZE

    FDA Adverse Event
    Injury ·ZIMMER SPINE·Product code MNH·October 30, 2019

    INSTINCT JAVA SCREW, UNKNOWN SIZE

    FDA Adverse Event
    Injury ·ZIMMER SPINE·Product code MNH·October 30, 2019

    INSTINCT JAVA SCREW, UNKNOWN SIZE

    FDA Adverse Event
    Injury ·ZIMMER SPINE·Product code MNH·October 30, 2019

    INSTINCT JAVA ROD, UNKNOWN

    FDA Adverse Event
    Injury ·ZIMMER SPINE·Product code MNH·October 30, 2019

    INSTINCT JAVA ROD, UNKNOWN

    FDA Adverse Event
    Injury ·ZIMMER SPINE·Product code MNH·October 31, 2019

    CD HORIZON® SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·WARSAW ORTHOPEDICS·Product code KWP·November 25, 2024

    BD INSYTE AUTOGUARD

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.·Product code FOZ·January 6, 2025

    INSTINCT JAVA SCREW, UNKNOWN SIZE

    FDA Adverse Event
    Injury ·ZIMMER SPINE·Product code MNH·October 31, 2019

    Exactech Equinoxe GLENOID, POSTERIOR AUGMENT,PEGGED, CEMENTED, 8o, LEFT, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-02-22, b) 41, 44, 47, 50 head, Medium, Item Number 314-02-23, c) 44, 47, 50, 53 head, Large, Item Number 314-02-24, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-02-25; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    Microtek Medical, Inc. ORS Fluid Warming and Slush Drapes, Model #'s ORS-100, ORS-110, ORS-130, ORS-300, ORS-301, ORS-320, ORS-321, ORS-325, ORS-330, ORS-331 and ORS-2200. The ORS Fluid Warming and Slush Drapes are individually wrapped and placed in poly-Tyvek pouches with a label insert, then packaged as 24 per case in a labeled corrugated shipper box. Intended for use during various surgeries where warm irrigation, slush and/or cold solution are required.

    FDA Enforcement
    Class II ·Terminated·Ecolab Inc·September 30, 2015