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

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    BION HSV1-G OR HSV2-G TEST SYSTEM

    FDA 510(k)
    FDA Class 2 ·Microbiology

    LinkSymphoKnee

    FDA UDI
    WALDEMAR LINK GmbH & Co. KG·04026575534418·Knee tibia prosthesis trial - LinkSymphoKnee

    LinkSymphoKnee

    FDA UDI
    WALDEMAR LINK GmbH & Co. KG·04026575534432·Knee tibia prosthesis trial - LinkSymphoKnee

    LinkSymphoKnee

    FDA UDI
    WALDEMAR LINK GmbH & Co. KG·04026575534449·Knee tibia prosthesis trial - LinkSymphoKnee

    LinkSymphoKnee

    FDA UDI
    WALDEMAR LINK GmbH & Co. KG·04026575534425·Knee tibia prosthesis trial - LinkSymphoKnee

    Curiteva Cervical Interbody Fusion System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DISPOSABLE COUPLING ADAPTOR

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    BIPOLAR LEAD MODEL 300

    FDA Adverse Event
    Malfunction ·CYBERONICS, INC.·Product code LYJ·October 6, 2010

    MEDEX MICRO BORE 72" EXTENSION SET W/ FILTER

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL, INC.·Product code FPB·February 18, 2014

    PROLIFT +M PELVIC FLOOR REPAIR

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code FTL·December 20, 2012

    EVOLUTION ESOPHAGEAL CONTROLLED-RELEASE STENT - FULLY COVERED

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code ESW·August 28, 2014

    Philips Azurion System configured with a 1 Phase UPS. Azurion family (R1.x, R2.x). Labeled as the following with corresponding model numbers: 1. Azurion 3 M12, Model Number 722063. 2. Azurion 3 M15, Model Number 722064. 3. Azurion 7 B12, Model Number 722067. 4. Azurion 7 B20, Model Number 722068. 5. Azurion 7 M12, Model Number 722078. 6. Azurion 7 M20, Model Number 722079. 7. Azurion 3 M12, Model Number 722221. 8. Azurion 3 M15, Model Number 722222. 9. Azurion 7 M12, Model Number 722223. 10. Azurion 7 M20, Model Number 722224. 11. Azurion 7 B12, Model Number 722225. 12. Azurion 7 B20, Model Number 722226. 13. Azurion 5 M12, Model Number 722227. 14. Azurion 5 M20, Model Number 722228. 15. Azurion 7 M20, Model Number 722282.

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

    Zeiss brand IOLMaster, Version 1-5, Biomicroscope, Slit-Lamp, AC-Powered, Product is manufactured by Carl Zeiss Meditec AG (Jena), Carl Zeiss Promenade 10, Jena, Germany 07745; and distributed by Carl Zeiss Meditec, Inc., Dublin, CA This device is intended for use primarily by physicians and health care workers and may be only used under the supervision of a physician. This device will not be sold to the general public. The IOLMaster is intended for the biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-to white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil. For patients who are candidates for intraocular lens (IOL) implantation, the device also performs calculations to assist physicians in determining the appropriate IOL power and type for implantation

    FDA Enforcement
    Class II ·Terminated·Carl Zeiss Meditec, Inc.·November 27, 2013