BEUDAMED
    15 results · 28ms · Sources: EU EUDAMED, US FDA

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    DIMENSION VISTA IMMUNOGLOBULIN A FLEX REAGENT CARTRIDGE (IGA), AND DIMENSION VISTA IMMUNOGLOBULIN M FLEX REAGENT CARTRID

    FDA 510(k)
    FDA Class 2 ·Immunology

    DJ ORTHOPEDICS POST SCREW

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    LOCKING SCREW MANDIBULAR RECONSTRUCTION PLATE

    FDA 510(k)
    FDA Class 2 ·Dental

    VKMO 78000 3 QUADROX-I HMO 70000+VHK7000

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOPULMONARY AG·Product code DTZ·February 25, 2015

    VKMO 78000 #QUADROX-I HMO 70000+VHK7000

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOPULMONARY AG·Product code DTZ·February 25, 2015

    ENDOCARE CRYOCARE CRYOPROBE, R1.7MM R/ANGLE

    FDA Adverse Event
    Malfunction ·HEALTHTRONICS, INC.·Product code GEH·March 2, 2011

    HLM TUBING SET W/SOFTLINE COATING

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOPULMONARY AG·Product code DWF·April 6, 2016

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Injury ·ANIMAS CORPORATION·Product code LZG·May 2, 2013

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·September 15, 2014

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 26, 2011

    3.5MM TI CANCELLOUS POLYAXIAL SCREW 22MM

    FDA Adverse Event
    Injury ·SYNTHES PRODUKTIONS GMBH·Product code NKG·February 8, 2018

    LOCKSCR SYNAPSE TAN

    FDA Adverse Event
    Injury ·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code NKG·February 15, 2018

    LOCKSCR SYNAPSE TAN

    FDA Adverse Event
    Injury ·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code NKG·February 15, 2018

    Zeiss brand IOLMaster 500, Model 500, 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

    IOL Master 500: Software versions 7.5 and 7.7; Ophthalmic: IOL Master 500 is intended for 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.

    FDA Enforcement
    Class II ·Terminated·Carl Zeiss Meditec AG·December 9, 2015