BEUDAMED
    41 results · 28ms · 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 ×

    BIOMED WOUND CLEANSER

    FDA 510(k)
    FDA Unclassified ·Unknown

    MSI Precision Specialty Instruments

    FDA UDI
    Med Saver, Inc.·00194613035914·Silicone Mat, Dimensions 6" x 10" (152mm x 254mm)

    ILIZAROV

    FDA UDI
    Smith & Nephew, Inc.·03596010029645·HALF PIN FIXATION BOLT 3MM

    CSU PEDIATRIC BALFOUR RETRACTOR

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896048485·CSU PEDIATRIC BALFOUR RETRACTOR SINGLE BAR

    HS Matchstick Bur,Ø3.0x125,80K

    FDA UDI
    Bien-Air Surgery SA·17630055507546·

    Arena-L®

    FDA UDI
    SPINEFRONTIER, INC.·00190361005568·Arena-L, Lordotic 10 degrees, 38X28X13

    Tiche PTA Balloon Dilatation Catheter

    FDA UDI
    BrosMed Medical Co.,Ltd.·06958481477696·

    MAGELLAN-2200, MODEL 1

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    VANGUARD BREAST MRI AUXILIARY TABLE WITH 16 CHANNEL COIL ARRAY FOR GE 3T MRI SYSTEM, MODEL 4000451-51

    FDA 510(k)
    FDA Class 2 ·Radiology

    WAVEWRITER ALPHA

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·July 1, 2024

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·May 8, 2013

    NATURALYTE

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·September 17, 2014

    EON MINI RECHARGEABLE IPG

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 17, 2011

    SMR CEMENTLESS FINNED STEM

    FDA Adverse Event
    Injury ·LIMACORPORATE S.P.A.·Product code HSD·July 29, 2021

    BD MAX¿ CPO

    FDA Adverse Event
    Malfunction ·GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)·Product code OOI·May 13, 2025

    BD MAX¿ CPO

    FDA Adverse Event
    Malfunction ·GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)·Product code OOI·January 21, 2025

    Brilliance iCT Computed Tomography X-ray system

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·December 30, 2015

    Brilliance iCT Computed Tomography X-ray Systems, Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·April 20, 2016

    Brilliance iCT - Model no. 728306 Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·April 25, 2018

    Brilliance iCT, Model No. 728306; To produce cross-sectional images of the body.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·August 17, 2016