BEUDAMED
    22 results · 24ms · Sources: EU EUDAMED, US FDA

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    SOMNOMED BFLEX

    FDA 510(k)
    FDA Class 2 ·Dental

    Matira

    FDA UDI
    Kalitec Direct LLC·B073K0730000·Plate Bender, Universal

    CosmoLock Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07311K0330040·Vise Grip, Small, 5.5mm

    CosmoLock Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07311K0730060·Rod Bender, 5.5 mm, 5 Position

    Kyocera Medical Technologies, Inc.

    FDA UDI
    KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523183715·Tk XL Trial Case

    Kyocera Medical Technologies, Inc.

    FDA UDI
    KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523183722·Tk XL Trial Tray 1

    AutoPulse®Resuscitation System

    FDA UDI
    Zoll Circulation, Inc.·00849111002431·The AutoPulse System consists of 4 primary comp...

    COCAINE

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    OSCAR 2, MODEL 222

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    AutoPulse®Resuscitation System

    FDA UDI
    Zoll Circulation, Inc.·00849111002172·The AutoPulse System consists of 4 primary comp...

    GRAFTYS BCP (510K NUMBER: K073064)

    FDA Adverse Event
    Injury ·GRAFTYS·Product code MQV·July 11, 2013

    TOTALCARE BARIATRIC

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·April 6, 2013

    ANIMAS VIBE

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·September 9, 2014

    ACCU-CHEK FLEXLINK PLUS

    FDA Adverse Event
    Malfunction ·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code FRN·April 21, 2011

    DIMENSION EXL WITH LM

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS·Product code JJE·June 13, 2013

    DIMENSION EXL 200

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS INC·Product code JJE·July 23, 2013

    PINNACLE SECTOR II CUP 60MM

    FDA Adverse Event
    Injury ·. DEPUY ORTHOPAEDIC INC, 1818910·Product code KWA·May 25, 2018

    Cytocell LPH019-A E2A (TCF3) Breakapart Probe- In Vitro Diagnostic Analyte specific reagents (ASR's)

    FDA Enforcement
    Class II ·Terminated·Cytocell Ltd.·August 25, 2021

    Vision Hollow Fiber Oxygenator with GBS Coating

    FDA Recall
    Terminated ·Gish Biomedical Inc·Product code DTZ·March 4, 2004

    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