BEUDAMED
    18 results · 23ms · Sources: EU EUDAMED, US FDA

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    REUSABLE TEST PACK FOR DANA EMULATING INDICATORS

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Automix-Dispenser Type 25 1:1

    FDA UDI
    DMG Chemisch-Pharmazeutische Fabrik GmbH·EDMG1102531·Automix-Dispenser, Type 25 1:1. Suitable for: L...

    Utrecht Interstitial Fletcher CT/MR Applicator

    FDA UDI
    Nucletron B.V.·08717213034754·Interstitial Ovoid Pair 20mm 25 °

    CORTAC®

    FDA UDI
    PMT CORPORATION·00650551002987·CORTAC GRID, 11X23, 0.76mm THICK, 1MM CONTACTS,...

    Cosmolock

    FDA UDI
    Kalitec Direct LLC·B07311K1100530·Caddie, 7.5mm Screws

    CORTAC®

    FDA UDI
    PMT CORPORATION·00650551003007·CORTAC GRID, 11X23, 0.76mm THICK, 1MM CONTACTS,...

    OSTEOSELECT DBM PUTTY

    FDA Adverse Event
    Injury ·BACTERIN·Product code MQV·November 29, 2012

    ANGIO FLOW THERMODILUTION CATHETER, MODEL AF-CATH-01; ANGIOFLOW METER, MODELS HQ100 AND HQ101

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    VISUMAX LASER KERATOME

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·May 13, 2013

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·September 23, 2014

    EPIC II CRITICAL CARE BED

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FNL·May 20, 2011

    CHECK-IT

    FDA Adverse Event
    Malfunction ·LUCIRA HEALTH, INC.·Product code QJR·January 14, 2023

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·April 7, 2011

    MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.

    FDA Recall
    Open, Classified ·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025

    MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.

    FDA Enforcement
    Class I ·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025

    EG-3630U Ultrasound Video Gastroscope EG-3830UT Ultrasound Video Gastroscope EG-3870UTK Ultrasound Video Gastroscope FG-36UX Ultrasound Fiber Gastroscope Used to provide optical and sonographic visualization of and therapeutic access to the Upper Gastrointestinal Tract.

    FDA Enforcement
    Class II ·Terminated·Pentax Medical Company·July 30, 2014

    Spectral CT. Computed tomography X-ray system.

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·July 2, 2025