BEUDAMED
    18 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 ×

    EBI XFIX OPTIROM KNEE FIXATOR

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SOLIDEA

    FDA UDI
    CALZIFICIO PINELLI SRL·08300496031093·STRONG, SIZE XL, CHAMPAGNE, MICRO-MASSAGING BER...

    LIFE SCIENCE OUTSOURCING, INC.

    FDA registration
    LIFE SCIENCE OUTSOURCING, INC.·59 products·🇺🇸 United States

    RealStar® ASR BKV Primer

    FDA UDI
    altona Diagnostics GmbH·04250453100802·BK virus (BKV) DNA specific primer

    RealStar® ASR BKV Probe

    FDA UDI
    altona Diagnostics GmbH·04250453100819·BK virus (BKV) DNA specific probe (FAM labeled)

    CosmoLock Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07311K0311930·Probe, 1.75 inch, Egg, Steffee, Long, Curved

    CosmoLock Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07311K0310030·Probe, 1.5 inch Ball, Steffee, Curved, Black

    Up & Up

    FDA UDI
    TARGET CORPORATION·00845717009355·Up&Up Basal Digital Thermometer

    AGILENT INFORMATION CENTER SOFTWARE FOR M3150,M3151,M3153 AND M3154

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CANDELA SPTL-1B PULSED DYE LASER

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    up&up

    FDA UDI
    TARGET CORPORATION·00642632760251·

    PINN MAR +4 NEUT 32IDX50OD

    FDA Adverse Event
    Injury ·1818910 DEPUY ORTHOPAEDICS, INC.·Product code LPH·April 2, 2013

    QUICKSILVER BIPOLAR COAGULATION PROBE

    FDA Adverse Event
    Malfunction ·WILSON-COOK MEDICAL, INC.·Product code KNS·March 16, 2011

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    FDA Adverse Event
    Injury ·CORDIS DE MEXICO·Product code NIQ·April 17, 2008

    Universal Nerve Block Tray Catalog Number: 9818

    FDA Enforcement
    Class II ·Terminated·Busse Hospital Disposables, Inc.·June 8, 2022

    HEALICOIL RG SA 5.5MM W/3 UB-BL CB BL BK- Absorbable Suture anchor Product Number: 72203707

    FDA Enforcement
    Class II ·Ongoing·Smith & Nephew, Inc.·October 28, 2020

    X-Flow prostatectomy catheter, Device Reference Numbers AB6022, AB6024, AB6118, AB6120, AB6122, AB6124, AB6220, AB6222, AB6224, AB6318, AB6320, AB6322, AB6324, AB6418, AB6420, AB6422, AB6424, AB6522, AB6524, AB6A18, AB6A20, AB6A22, AB6A24, AB6C18, AB6C20, AB6C22, and AB6C24.

    FDA Enforcement
    Class II ·Ongoing·Coloplast Manufacturing US, LLC·January 22, 2025

    Drager Infinity CentralStation Software versions VG2.1.2 and VG2.1.2 SU12. For patient monitoring with Infinity M300 wireless telemetry devices.

    FDA Enforcement
    Class II ·Ongoing·Draegar Medical Systems, Inc.·May 4, 2022