BEUDAMED
    116 results · 12ms · Sources: EU EUDAMED, US FDA

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    Oxford/Oxbridge AFN End Cap 10 mm x 5 mm tp 12 mm x10 mm The end caps are a circular disk with a small threaded shaft to be screwed to the distal end of the Nail.

    FDA Recall
    Terminated ·Ortho Solutions Inc·Product code HSB·April 19, 2017

    Rapid fFN for the TLi IQ system and specimen collection kit in the following configurations: 01166 Rapid fFN Control Kit ; manufactured by Hologic, Sunnyvale, CA. Medical device for use in assessment of preterm birth risk. Enzyme Immunoassay, Fetal Fibronectin and Device for Specimen Collection (code LIO). The Rapid fFN test is approved for the indication to aid to rapidly assess the risk of preterm delivery in = 7 or = 14 days from the time of cervicovaginal sample collection in pregnant women with signs and symptoms of early preterm labor, intact amniotic membranes and minimal cervical dilation (< 3cm), sampled between 24 weeks, 0 days and 34 weeks, 6 days gestation. The test is further indicated for use in conjunction with other clinical information as an aid to rapidly assess the risk of preterm delivery in = 34 weeks, 6 days when a cervicovaginal sample is obtained during a routine prenatal visit between 22 weeks, 0 days and 30 weeks, 6 days of gestation in women with a singleton pregnancy.

    FDA Recall
    Terminated ·Cytyc Prenatal Products/Hologic Inc.·Product code lkv·December 15, 2009

    Rapid fFN for the TLi IQ system and specimen collection kit in the following configurations: 01200/1200Q Rapid fFN Cassette Kit; manufactured by Hologic, Sunnyvale, CA. Medical device for use in assessment of preterm birth risk. Enzyme Immunoassay, Fetal Fibronectin and Device for Specimen Collection (code LIO). The Rapid fFN test is approved for the indication to aid to rapidly assess the risk of preterm delivery in = 7 or = 14 days from the time of cervicovaginal sample collection in pregnant women with signs and symptoms of early preterm labor, intact amniotic membranes and minimal cervical dilation (< 3cm), sampled between 24 weeks, 0 days and 34 weeks, 6 days gestation. The test is further indicated for use in conjunction with other clinical information as an aid to rapidly assess the risk of preterm delivery in = 34 weeks, 6 days when a cervicovaginal sample is obtained during a routine prenatal visit between 22 weeks, 0 days and 30 weeks, 6 days of gestation in women with a singleton pregnancy.

    FDA Recall
    Terminated ·Cytyc Prenatal Products/Hologic Inc.·Product code LKV·December 15, 2009

    O-arm" O2 Imaging System, Product Number/CFN: BI-700-02000

    FDA Recall
    Terminated ·Medtronic Navigation, Inc.-Littleton·Product code OWB·November 15, 2019

    Covidien Emprint Ablation Catheter with Thermosphere Technology Bronchoscopic Ablation, CFN CA108L1

    FDA Recall
    Terminated ·Covidien Llc·Product code NEY·September 29, 2021

    Rapid for the TLiIQ(R) System, HOLOGIC(R), Catalog number: 01200Q

    FDA Recall
    Terminated ·Hologic, Inc.·Product code LKV·November 29, 2017

    Rapid for the TLiIQ(R) System, HOLOGIC(R), Catalog number: 01200

    FDA Recall
    Terminated ·Hologic, Inc.·Product code LKV·November 29, 2017

    O-arm" O2 Imaging System, Product Number/CFN: BI-700-02000

    FDA Enforcement
    Class II ·Terminated·Medtronic Navigation, Inc.-Littleton·January 8, 2020

    Covidien Emprint Ablation Catheter with Thermosphere Technology Bronchoscopic Ablation, CFN CA108L1

    FDA Enforcement
    Class II ·Terminated·Covidien Llc·November 17, 2021

    Medical Device Identification Cards associated with Sprint Quattro Lead, Product/CFN 6935M72

    FDA Enforcement
    Class II ·Terminated·Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)·December 22, 2021

    Rapid fFN for the TLi IQ system and specimen collection kit in the following configurations: 1202 TLiIQ Analyzer Boxed Set (includes Analyzer/Printer and QCette). manufactured by Hologic, Sunnyvale, CA. Medical device for use in assessment of preterm birth risk. Enzyme Immunoassay, Fetal Fibronectin and Device for Specimen Collection (code LIO). The Rapid fFN test is approved for the indication to aid to rapidly assess the risk of preterm delivery in = 7 or = 14 days from the time of cervicovaginal sample collection in pregnant women with signs and symptoms of early preterm labor, intact amniotic membranes and minimal cervical dilation (< 3cm), sampled between 24 weeks, 0 days and 34 weeks, 6 days gestation. The test is further indicated for use in conjunction with other clinical information as an aid to rapidly assess the risk of preterm delivery in = 34 weeks, 6 days when a cervicovaginal sample is obtained during a routine prenatal visit between 22 weeks, 0 days and 30 weeks, 6 days of gestation in women with a singleton pregnancy.

    FDA Recall
    Terminated ·Cytyc Prenatal Products/Hologic Inc.·Product code LKV·December 15, 2009

    Rapid fFN for the TLi IQ system and specimen collection kit in the following configurations: 71738 Specimen Collection Kit (25 pack); manufactured by Hologic, Sunnyvale, CA. Medical device for use in assessment of preterm birth risk. Enzyme Immunoassay, Fetal Fibronectin and Device for Specimen Collection (code LIO). The Rapid fFN test is approved for the indication to aid to rapidly assess the risk of preterm delivery in = 7 or = 14 days from the time of cervicovaginal sample collection in pregnant women with signs and symptoms of early preterm labor, intact amniotic membranes and minimal cervical dilation (< 3cm), sampled between 24 weeks, 0 days and 34 weeks, 6 days gestation. The test is further indicated for use in conjunction with other clinical information as an aid to rapidly assess the risk of preterm delivery in = 34 weeks, 6 days when a cervicovaginal sample is obtained during a routine prenatal visit between 22 weeks, 0 days and 30 weeks, 6 days of gestation in women with a singleton pregnancy.

    FDA Recall
    Terminated ·Cytyc Prenatal Products/Hologic Inc.·Product code LKV·December 15, 2009

    Rapid fFN for the TLi IQ system and specimen collection kit in the following configurations: 1175 TLiIQ QCette ; manufactured by Hologic, Sunnyvale, CA. Medical device for use in assessment of preterm birth risk. Enzyme Immunoassay, Fetal Fibronectin and Device for Specimen Collection (code LIO). The Rapid fFN test is approved for the indication to aid to rapidly assess the risk of preterm delivery in = 7 or = 14 days from the time of cervicovaginal sample collection in pregnant women with signs and symptoms of early preterm labor, intact amniotic membranes and minimal cervical dilation (< 3cm), sampled between 24 weeks, 0 days and 34 weeks, 6 days gestation. The test is further indicated for use in conjunction with other clinical information as an aid to rapidly assess the risk of preterm delivery in = 34 weeks, 6 days when a cervicovaginal sample is obtained during a routine prenatal visit between 22 weeks, 0 days and 30 weeks, 6 days of gestation in women with a singleton pregnancy.

    FDA Recall
    Terminated ·Cytyc Prenatal Products/Hologic Inc.·Product code LKV·December 15, 2009

    Rapid fFN for the TLi IQ system and specimen collection kit in the following configurations: 0797 Specimen Collection Kit (8 pack); manufactured by Hologic, Sunnyvale, CA. Medical device for use in assessment of preterm birth risk. Enzyme Immunoassay, Fetal Fibronectin and Device for Specimen Collection (code LIO). The Rapid fFN test is approved for the indication to aid to rapidly assess the risk of preterm delivery in = 7 or = 14 days from the time of cervicovaginal sample collection in pregnant women with signs and symptoms of early preterm labor, intact amniotic membranes and minimal cervical dilation (< 3cm), sampled between 24 weeks, 0 days and 34 weeks, 6 days gestation. The test is further indicated for use in conjunction with other clinical information as an aid to rapidly assess the risk of preterm delivery in = 34 weeks, 6 days when a cervicovaginal sample is obtained during a routine prenatal visit between 22 weeks, 0 days and 30 weeks, 6 days of gestation in women with a singleton pregnancy.

    FDA Recall
    Terminated ·Cytyc Prenatal Products/Hologic Inc.·Product code LKV·December 15, 2009

    Oxford/Oxbridge AFN End Cap 10 mm x 5 mm tp 12 mm x10 mm The end caps are a circular disk with a small threaded shaft to be screwed to the distal end of the Nail.

    FDA Enforcement
    Class II ·Terminated·Ortho Solutions Inc·August 9, 2017

    Medical Device Identification Cards associated with Astra XT DR Implantable pulse generator

    FDA Enforcement
    Class II ·Terminated·Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)·December 22, 2021

    Software 1898072 IPC upgrade v 2.7.3.0 - Product Usage: The IPC system is indicated for the incision/cutting removal, drilling and sawing of soft and hard tissue and bone in surgical procedures.

    FDA Recall
    Terminated ·Medtronic Xomed, Inc.·Product code ERL·June 12, 2020

    iPico Product Usage: Muscle stimulation

    FDA Recall
    Terminated ·Ion Genius, Inc.·Product code NFO·January 6, 2012

    Perfector Product Usage: Muscle stimulation

    FDA Recall
    Terminated ·Ion Genius, Inc.·Product code IPF·January 6, 2012

    Ion Magnum Product Usage: Muscle stimulation

    FDA Recall
    Terminated ·Ion Genius, Inc.·Product code IPF·January 6, 2012