BEUDAMED
    19 results · 30ms · 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 ×

    IPL Hair Removal Device (KCA511/KCA516/KCA522)

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

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776183240·Lambotte Osteotome str

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776414306·ROUND BOWEL GRASPER 32CM

    ELMED INCORPORATED

    FDA UDI
    ELMED INCORPORATED·00198506075353·5 MM DIA., 32 CM ROUND BOWEL GRASPER, STAINLESS...

    Vilex Guidewire

    FDA UDI
    VILEX IN TENNESSEE, INC.·00841731120755·Guidewire 2.5x250mm Drill Tip

    Vilex Guidewire

    FDA UDI
    VILEX IN TENNESSEE, INC.·00841731120762·Guidewire 2.5x250mm Sgl Trocar

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776183257·LAMBOTTE OSTEOTOME STRAIGHT

    USGI SHAPELOCK ENDOSCOPIC GUIDE

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

    Disposable Suction Irrigation, 330mm, Disposable Suction Irrigation, 450mm

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

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·November 4, 2022

    GLIDEWELL HT IMPLANT Ø4.3 X 10 MM

    FDA Adverse Event
    Injury ·PRISMATIK DENTALCRAFT, INC.·Product code DZE·May 6, 2025

    GLIDEWELL HT IMPLANT Ø4.3 X 10 MM

    FDA Adverse Event
    Injury ·PRISMATIK DENTALCRAFT, INC.·Product code DZE·February 11, 2026

    PUMP MMT-1780KPK 670G PATHWAY BLACK MG

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·April 28, 2021

    GORE TEX VASCULAR GRAFT

    FDA Adverse Event
    Injury ·W.L. GORE & ASSOCIATES, INC·Product code DSY·April 21, 2011

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FKX·November 14, 2014

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 15, 2011

    CVC KIT: 3-LUMEN 7 FR X 8" (20

    FDA Adverse Event
    Malfunction ·ARROW INTL., INC.·Product code DQY·July 24, 2013

    PRODIGY AUTOCODE

    FDA Adverse Event
    Injury ·OK BIOTECH CO., LTD.·Product code NBW·November 23, 2017

    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