BEUDAMED
    15 results · 21ms · Sources: EU EUDAMED, US FDA

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    SENTIERO

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776297220·Littler Scissors 4 3/4" sharp tip curved with eye

    Contours™ Finishing & Polishing Discs Mandrel Kit Refill Pack

    FDA UDI
    CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.·07540172016773·Aluminum oxide dental finishing and polishing a...

    Contours™ Finishing & Polishing Discs Mandrel Kit Refill Pack

    FDA UDI
    DEN-MAT HOLDINGS, LLC·00359883006266·Aluminum oxide dental finishing and polishing a...

    STILLE Osteotomes

    FDA UDI
    Stille AB·07332339206567·OSTEOTOME ORIGINAL STILLE 12 mm 21 cm 8.25 in

    PROMOS MODULAR SHOULDER SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    EXACTECH BIOLOXDELTA / BIOLOX FEMORAL HEADS, 28MM OD, 32MM OD, 36MM OD, EXACTECH BIOLOX OPTION ADAPTERS/FEMORAL HEADS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Gibralt

    FDA UDI
    Choice Spine, LP·00840996169585·GIBRALT,DRILL,FIXED,3.0X12

    ZELTIQ COOLCORE (6.3)

    FDA Adverse Event
    Injury ·ZELTIQ AESTHETICS INC.·Product code OOK·June 19, 2014

    AVENIR® MüLLER, STEM, STANDARD, UNCEMENTED, HA, 4, TAPER 12/14

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code LZO·January 9, 2025

    SPARC SLING SYSTEM

    FDA Adverse Event
    Injury ·AMERICAN MEDICAL SYSTEMS, INC.·Product code OTN·May 16, 2013

    S2S/SUR-FIT NATURA 2 PC - 2 PC UROSTOMY POUCH W/ACCUSEAL TAP

    FDA Adverse Event
    Malfunction ·CONVATEC DOMINICAN REPUBLIC, INC.·Product code EXH·September 29, 2014

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Death ·AV-TEMECULA-CT·Product code NIQ·June 17, 2011

    The device is a whole-body CT x-ray system. The acquired x-ray transmission data is reconstructed by computer into cross-sectional images of the body taken at different angles and planes. The system also includes signal analysis and display equipment, patient and equipment supports, components, and accessories. Philips Inclusive CT has a 72cm bore and includes a detector array that provides 50cm scan field of view.

    FDA Enforcement
    Class II ·Completed·Philips North America Llc·December 27, 2023

    OPTETRAK Comprehensive Knee System including OPTETRAK All-polyethylene UNI Tibial Components, Product Lines, 252-12-XX, 252-13-XX, 252-22-XX, 252-23-XX. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021