BEUDAMED
    19 results · 20ms · Sources: EU EUDAMED, US FDA

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    Helio A7 Manual Wheelchair, Move Manual Wheelchair

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690128939·Femoral Augment, Notched Posterior, Size 3+, 10mm

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690188278·NOTCHED POSTERIOR AUGMENT TRIAL REVISION FEMUR ...

    OtoProbe™ Long Angled Single

    FDA UDI
    IRIDEX CORPORATION·00851089000432·

    HI-TORQUE BALANCE MIDDLEWEIGHT ELITE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    NEXGEN COMPLETE KNEE SOLUTION MIS TIBIAL COMPONENTS, LOCKING SCREW AND STEM EXTENSIONS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    IRIDEX OTOPROBE LONG AND SHORT ANGLES, P/N 14310-1 AND 14320-1

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

    OMNIFIX®

    FDA Adverse Event
    Malfunction ·B BRAUN MELSUNGEN AG·Product code FMF·March 6, 2026

    ZEPHYR XL DR

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DXY·January 13, 2014

    UNKNOWN PELVICOL PRODUCT

    FDA Adverse Event
    Injury ·COVIDIEN, FORMERLY TISSUE·Product code FTL·May 24, 2013

    EON MINI 16-CHANNEL RECHARGEABLE IPG

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·June 23, 2011

    EAGLE EYE PLATINUM SHORT TIP

    FDA Adverse Event
    Injury ·VOLCANO CORPORATION·Product code OBJ·July 1, 2016

    EAGLE EYE PLATINUM SHORT TIP; EAGLE EYE PLATINUM ST CATHETER

    FDA Adverse Event
    Injury ·VOLCANO CORPORATION·Product code OBJ·July 1, 2016

    EAGLE EYE PLATINUM SHORT TIP; EAGLE EYE PLATINUM ST CATHETER

    FDA Adverse Event
    Injury ·VOLCANO CORPORATION·Product code OBJ·July 1, 2016

    Microtek Medical, Inc. ORS Fluid Warming and Slush Drapes, Model #'s ORS-100, ORS-110, ORS-130, ORS-300, ORS-301, ORS-320, ORS-321, ORS-325, ORS-330, ORS-331 and ORS-2200. The ORS Fluid Warming and Slush Drapes are individually wrapped and placed in poly-Tyvek pouches with a label insert, then packaged as 24 per case in a labeled corrugated shipper box. Intended for use during various surgeries where warm irrigation, slush and/or cold solution are required.

    FDA Enforcement
    Class II ·Terminated·Ecolab Inc·September 30, 2015

    Philips AneurysmFlow. Model Number: 001015. AneurysmFlow is a software medical device (Interventional Tool) intended to be used in combination with a Philips interventional X-ray system and 3DRA data.

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 22, 2026

    Allura system; System Code Description (Model Numbers): Allura Xper FD10C (722001), Allura Xper FD10F (722002), Allura Xper FD10 (722003, 722010, 722026), Allura Xper FD10/10 (722005, 722011, 722027), Allura Xper FD20 (722006, 722012, 722028), Allura Xper FD20 Biplane (722008, 722013), Allura Xper FD20 OR Table (722015, 722023, 722035), Allura Xper FD20 Biplane OR Table (722025), Allura Xper FD20/10 (722029), Allura Xper FD20/15 (722058), Allura Xper FD20/15 OR Table (722059), Allura Xper FD20/20 (722038), Allura Xper FD20/20 OR Table (722039), Cardio Vascular-Allura (722400);

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·May 27, 2026

    Allura system; System Code Description (Model Numbers): Allura Xper FD10 (722003, 722010, 722026), Allura Xper FD10 OR Table (722022, 722033), Allura Xper FD10/10 (722005, 722011, 722027), Allura Xper FD20 (722006, 722012, 722028), Allura Xper FD20 Biplane (722008, 722013), Allura Xper FD20 OR Table (722015, 722023, 722035), Allura Xper FD20 Biplane OR Table (722025), Allura Xper FD20/10 (722029), Allura Xper FD20/15 (722058), Allura Xper FD20/15 OR Table (722059), Allura Xper FD20/20 (722038), Allura Xper FD20/20 OR Table (722039);

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·June 3, 2026

    Philips Azurion Interventional Fluoroscopic X-Ray System, Software version 2.1.x, Model numbers 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222, 722223, 722224, 722225, 722226, 722227, 722228. (Azurion 3 M12, Azurion 3 M15, Azurion 5 M12, Azurion 5 M20, Azurion 7 B12, Azurion 7 B20, Azurion 7 M12, Azurion 7 M20)

    FDA Enforcement
    Class II ·Terminated·Philips North America Llc·November 17, 2021