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

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    ROCHE ELECSYS PTH TEST SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Up&Up

    FDA UDI
    TARGET CORPORATION·06945397906228·Hot+Cold Gel Bead Back Wrap with Strap - up & up

    WAVEWRITER ALPHA

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·November 14, 2023

    MODIFICATION TO CD HORIZON SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MENTOR STERILE SALINE MAMMARY VOLUME SIZERS

    FDA 510(k)
    FDA Unclassified ·Unknown

    ADVISOR VITAL SIGNS MONITOR

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL PM, INC.·Product code CCK·December 24, 2008

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·WARSAW ORTHOPEDICS·Product code KWP·December 30, 2015

    ADVISOR VITAL SIGNS MONITOR

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL PM, INC·Product code DQK·April 28, 2010

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDICS·Product code KWP·May 1, 2014

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·WARSAW ORTHOPEDIC, INC.·Product code KWP·August 1, 2011

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·WARSAW ORTHOPEDICS·Product code KWP·May 15, 2013

    Multiphor II Electrophoresis System GE HealthCare Product Number: 18-1018-06 PerkinElmer Part Number: 2117-004 Product Usage: Multiphor II Electrophoresis System is a versatile modular electrophoresis system for horizontal electrophoresis, isoelectric focusing, 2-D electrophoresis and electrophoretic transfer Note: The Multiphor II Electrophoresis System (Class I) is the platform used with the hemoglobin electrophoresis gel kit ( Class II) sold by PerkinElmer as the Resolve Hemoglobin Kit (K050709: Product code JJN). The RESOLVE Systems Hemoglobin kit (K050709) is designed to separate whole blood, cord blood or dried blood spot specimen for detection of normal and variant hemoglobins by isoelectric focusing.

    FDA Enforcement
    Class II ·Terminated·Perkinelmer Life Sciences, Inc.·July 12, 2017

    Multiphor II Electrophoresis System GE HealthCare Product Number: 18-1018-06 PerkinElmer Part Number: 2117-004 Product Usage: Multiphor II Electrophoresis System is a versatile modular electrophoresis system for horizontal electrophoresis, isoelectric focusing, 2-D electrophoresis and electrophoretic transfer Note: The Multiphor II Electrophoresis System (Class I) is the platform used with the hemoglobin electrophoresis gel kit ( Class II) sold by PerkinElmer as the Resolve Hemoglobin Kit (K050709: Product code JJN). The RESOLVE Systems Hemoglobin kit (K050709) is designed to separate whole blood, cord blood or dried blood spot specimen for detection of normal and variant hemoglobins by isoelectric focusing.

    FDA Recall
    Terminated ·Perkinelmer Life Sciences, Inc.·Product code JJN·May 15, 2017

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·April 22, 2013

    ACCESS WASH BUFFER II

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

    LINER CANNSTR SUCT 3000CC DISP

    FDA Adverse Event
    Other ·CARDINAL HEALTH·Product code KDQ·July 3, 2008

    TOPAZ MicroDebrider 0.8 mm REF AC4040-01; TOPAZ MicroDebrider IFS 0.8 mm REF ACH4040-01; TOPAZ MicroDebrider 0.8 mm REF Q6000-01; TOPAZ EPF MicroDebrider 0.8 mm 45 REF Q6002-01

    FDA Enforcement
    Class II ·Terminated·ArthroCare Corporation·April 13, 2016