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

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    SOF-TACT DIABETES MANAGEMENT SYSTEM; SOF-TACT GLUCOSE TEST STRIP; PRECISION CONTROL SOLUTIONS

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    GRADIA®

    FDA UDI
    Gc America Inc.·D0470019931·GRADIA® DIRECT Syringes: 1 syringe (2.7mL) CV

    GRADIA®

    FDA UDI
    Gc America Inc.·14548161073752·GRADIA® DIRECT Syringes: 1 syringe (2.7mL) CV

    LIBERTY 9000 BREAST COIL

    FDA 510(k)
    FDA Class 2 ·Radiology

    CANDELA SPTL-1B PULSED DYE LASER

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER 36/+3MM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code PHX·December 1, 2020

    SUMMIT POR TAPER SZ6 STD OFF

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDIC INC, 1818910·Product code LPH·June 21, 2018

    PMT TORQUE DRIVER

    FDA Adverse Event
    Other ·PMT CORP.·Product code HXX·March 8, 2013

    COLLEAGUE COLOR PUMP CE FRENCHVERSION SINGLE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·February 27, 2011

    COZMO INSULIN PUMP

    FDA Adverse Event
    Injury ·SMITHS MEDICAL MD (FORMERLY DELTEC, INC)·Product code LZG·February 22, 2008

    SUMMIT POR TAPER SZ4 HI OFF

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDIC INC, 1818910·Product code LPH·June 20, 2018

    SUMMIT POR TAPER SZ6 HI OFF

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDIC INC, 1818910·Product code LPH·June 1, 2018

    SUMMIT POR TAPER SZ4 HI OFF

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code LPH·September 28, 2018

    SUMMIT POR TAPER SZ7 HI OFF

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code LPH·October 18, 2019

    SUMMIT POR TAPER SZ4 HI OFF

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC. - 8010379·Product code LPH·July 1, 2015

    PINN CAN BONE SCREW 6.5MMX15MM

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code LPH·August 14, 2018

    SUMMIT POR TAPER SZ6 STD OFF

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code LPH·August 14, 2018

    PINN CAN BONE SCREW 6.5MMX25MM

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code LPH·August 14, 2018

    Brilliance 64 Model # 728231, computed tomography x-ray system

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·August 14, 2019

    Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular tachyarrhythmias.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·March 27, 2013