BEUDAMED
    20 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 ×

    OHMEDA MEDICAL GIRAFFE INCUBATOR

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450130117·

    CosmoLock Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07311K0100220·Caddie, Rods, Adjustable Cross Links, and Caps

    Matira

    FDA UDI
    Kalitec Direct LLC·B07307K0100220·Assembly, Caddie, 1-3L Plates, Hnged

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033317440·

    Kalitec Special

    FDA UDI
    Kalitec Direct LLC·B073DRK0100220·SNII Awl Tap, 6.50mm

    AUTOSOFT XC

    FDA Adverse Event
    Malfunction ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·June 2, 2025

    NIDO Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07315K0112220·Tap, 4.75mm Cortical, SNI1

    Cosmolock

    FDA UDI
    Kalitec Direct LLC·B07311K0112220·Tap, 4.75mm Cannulated, Fixed Sleeve

    REMSTART AUTO

    FDA Adverse Event
    Injury ·PHILIPS RESPIRONICS·Product code CBK·November 26, 2014

    SureCore Automatic Disposable Biopsy Needle

    FDA UDI
    Canyon Medical Inc.·06954414643060·Automatic Disposable Biopsy Needle

    OTW MEGALINK SDS BILLIARY STENT SYSTEM, MODELS 1005509-18, 1005510-18, 1005511-18, 1005512-18, 1005509-28, 1005510-28, 1

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

    UM-L25

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

    FRESENIUS DIALYSIS DELIVERY SYSTEM

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KDI·March 12, 2013

    GOBED+

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FNL·March 1, 2011

    MANUAL ORTHOPEDIC SURGICAL INSTRUMENT

    FDA Adverse Event
    Malfunction ·MEDTRONIC SOFAMOR DANEK·Product code HXX·March 6, 2008

    Instructions For Use document of the GPS Trackers.

    FDA Enforcement
    Class II ·Terminated·Blue Ortho·November 4, 2020

    Allura Xper FD10 - Catalog numbers: (1) 722003, (2) 722010, (3) 722026,

    FDA Enforcement
    Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025

    Medfusion Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model 4000-0101-50, Model 4000-0101-51, Model 4000-0101-78, Model 4000-0105-249, Model 4000-0105-51, Model 4000-0105-78, Model 4000-0106-00, Model 4000-0106-01, Model 4000-0106-231

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·June 29, 2022

    Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 23, 2013