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

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    SERUM BICARBONATE/CARBON DIOXIDE

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    KMEDIC

    FDA UDI
    TELEFLEX INCORPORATED·24026704285994·

    DENTHESIVE

    FDA 510(k)
    FDA Class 2 ·Dental

    PHILIPS INTEGRIS H/HM SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    PREMICATH PICC

    FDA Adverse Event
    Malfunction ·VYGON GMBH·Product code LJS·May 20, 2015

    PREMICATH PICC

    FDA Adverse Event
    Malfunction ·VYGON GMBH·Product code LJS·May 22, 2015

    PREMICATH

    FDA Adverse Event
    Malfunction ·VYGON GMBH·Product code LJS·April 20, 2015

    PREMICATH

    FDA Adverse Event
    VYGON GMBH·Product code LJS·April 20, 2015

    PREMICATH PICC

    FDA Adverse Event
    Malfunction ·VYGON GMBH·Product code LJS·June 3, 2015

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Injury ·MPRI·Product code DTB·February 11, 2013

    CURRENT ACCEL VR

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·January 10, 2011

    MINIMAL ACCESS ATTACHEMENT

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code HBE·December 13, 2013

    Covidien Trellis 6 and Trellis 8 Peripheral Infusion Systems, Sterile EO, Rx only. Models BVT608010V01, BVT608030V01, BVT612010V01, BVT612030V01, CVT808015, CVT808025, CVT812015, CVT812025, EVT808015, EVT808025, EVT812015, EVT812025, BVT808015, BVT808030, BVT812015, BVT812030, EUT808015, EUT808030, EUT812015, EUT812030. Product Usage: The Trellis 6 and Trellis 8 peripheral infusion system is intended for controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.

    FDA Enforcement
    Class II ·Terminated·Medtronic Inc. Cardiac Rhythm Disease Management·April 8, 2015

    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