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

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    C-WIRE DOUBLE ENDED ORTHOPEDIC WIRES

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Gyrus ACMI

    FDA UDI
    Gyrus ACMI, LLC·00821925017078·RICHARDS FLUOROPLASTIC BUCKET HANDLE PROTHESIS,...

    MAXIM VI KNEE SYSTEM

    FDA UDI
    Biomet Orthopedics, LLC·00880304205505·

    DEPUY HPS

    FDA Adverse Event
    Injury ·DEPUY ORTHOPEDICS·Product code KWA·December 9, 2010

    VERSATILE 1 WOUND VACUUM SYSTEM

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

    MODEL LA-1200 MULTI-CHANNEL LASER THERAPY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    AVAULTA SOLO SYNTHETIC SUPPORT SYSTEM - POSTERIOR

    FDA Adverse Event
    Injury ·BARD SHANNON LIMITED·Product code FTL·May 29, 2013

    PENUMBRA COIL 400 DETACHMENT HANDLE

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code HCG·May 26, 2011

    AESTIVA 7900

    FDA Adverse Event
    Malfunction ·DATEX-OHMEDA, INC.·Product code CBK·October 9, 2015

    OT ULTRA METER

    FDA Adverse Event
    Injury ·LIFESCAN INC.·Product code NBW·November 16, 2010

    ANALYTICAL P MODULE

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·March 31, 2010

    PKG, GRASPER FORCEPS, SERRSTED FENESTRATED, P/N 0250080318. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.

    FDA Enforcement
    Class II ·Terminated·Stryker Endoscopy·December 24, 2014

    Philips Allura System configured with a 1 Phase UPS. Allura family (R1.x, R2.x). Labeled as the following with corresponding model numbers: 1. Allura Xper FD10, Model Number 722003 2. Allura Xper FD10/10, Model Number 722005 3. Allura Xper FD20, Model Number 722006 4. Allura Xper FD20 Biplane, Model Number 722008 5. Allura Xper FD10, Model Number 722010 6. Allura Xper FD10/10, Model Number 722011 7. Allura Xper FD20, Model Number 722012 8. Allura Xper FD20 Biplane, Model Number 722013 9. Allura Xper FD20 OR Table, Model Number 722023 10. Allura Xper FD10, Model Number 722026 11. Allura Xper FD10/10, Model Number 722027 12. Allura Xper FD20, Model Number 722028 13. Allura Xper FD20/10, Model Number 722029 14. Allura Xper FD20 OR Table, Model Number 722035 15. Allura Xper FD20/20, Model Number 722038 16. Allura Xper FD20/15, Model Number 722058 17. Allura Xper FD20/15 OR Table, Model Number 722059.

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·September 10, 2025

    Transseptal Needle, Trocar. RPN TSNC-18-71.0, TSNC-19-56.0. GPN G02364, G02365. Product consists of a transseptal needle and obturator.

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·November 24, 2021