BEUDAMED
    12 results · 27ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

    ESCORT 100/300 SERIES B (ESCORT II) PATIENT MONITOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690198680·AK3 Ultra Insert Trial Size 4, 13mm

    Arthrex®

    FDA UDI
    ARTHREX, INC.·00888867401020·2.4mm Snap-off FT Pin 13mm

    SiteSeal Femoral Compression Device

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    INVIROSNAP 50 AND 100 UNIT INSULIN SAFETY SYRINGES

    FDA 510(k)
    FDA Class 2 ·General Hospital

    BIOPSYS DRIVERS

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, INC.(CINCINNATI)·Product code KNW·June 8, 2006

    BIOPSYS DRIVERS

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, INC.(CINCINNATIA)·Product code KNW·June 8, 2006

    BIOPSYS DRIVERS

    FDA Adverse Event
    Malfunction ·ETHICON ENDO SURGERY, INC. (CINCINNATI)·Product code KNW·June 7, 2006

    UNKNOWN DEPUY PINNACLE METAL LINER

    FDA Adverse Event
    Injury ·DEPUY INTL., LTD. ¿ REG. # 8010379·Product code KWA·March 7, 2013

    CAPSUREFIX

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·February 15, 2011

    EVERA XT DR

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LWS·August 8, 2014

    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