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

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    EXPLORER GRADIENT

    FDA 510(k)
    FDA Class 2 ·Radiology

    Custom Procedure Kit

    FDA UDI
    MEDIVATORS INC.·40677964016866·The ENDO CARRY-ON Procedure Kit contains all of...

    GRADIA®

    FDA UDI
    Gc America Inc.·D0470019871·GRADIA® DIRECT Unitips: 10 tips Anterior - 0.16...

    GRADIA®

    FDA UDI
    Gc America Inc.·14548161073691·GRADIA® DIRECT Unitips: 10 tips Anterior - 0.16...

    PTA BALLOON CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    VFSS IMAGER, MODEL SIS-300

    FDA 510(k)
    FDA Class 2 ·Radiology

    AUTOCAT2 WAVE

    FDA Adverse Event
    Malfunction ·ARROW INTL., INC.·Product code DSP·March 11, 2013

    SYNCHRON LX 20 PRO CLINICAL SYSTEMS

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code JJE·February 27, 2011

    OT ULTRA2 METER

    FDA Adverse Event
    Injury ·LIFESCAN, INC.·Product code NBW·February 21, 2008

    HLM TUBING SET

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOPULMONARY AG·Product code DTM·July 6, 2016

    HAND PIECE FOR BATTERY POWERED DRIVER

    FDA Adverse Event
    Malfunction ·SYNTHES MONUMENT·Product code HXX·July 6, 2015

    T:slim Insulin Delivery System Insulin Infusion Pump

    FDA Enforcement
    Class I ·Terminated·Tandem Diabetes Care Inc·February 19, 2014

    PF4 Concentrated Wash (10x), REF 403624, packaged in the following assay kits: 1. ImmucorGamma LIFECODES PF4 IgG (catalog numbers HAT13G, HAT45G) and 2. ImmucorGamma LIFECODES PF4 Enhanced (catalog numbers X-HAT13, X-HAT45) The PF4 IgG assay is an Enzyme Linked Immunosorbent Assay (ELISA). The PF4 IgG ELISA is intended to detect IgG antibodies in human serum that react with Platelet Factor 4 (PF4) when it is complexed to heparin or other polyanionic compounds. The PF4 IgG kit contains all of the reagents necessary to perform the assay.

    FDA Enforcement
    Class II ·Terminated·Genetic Testing Institute,inc·January 28, 2015

    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