BEUDAMED
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    Iridex TruFocus LIO Premiere" Laser Indirect Ophthalmoscope ( LIO ) The LIO is a headmounted indirect ophthalmoscope which is used with a handheld lens to view and perform laser treatments on a patient s retina. It allows binocular visualization of the peripheral retina and can be used to evaluate and treat patients.

    FDA Enforcement
    Class II ·Terminated·Iridex Corporation·March 28, 2018

    Iridex TruFocus LIO Premiere" Laser Indirect Ophthalmoscope ( LIO ) The LIO is a headmounted indirect ophthalmoscope which is used with a handheld lens to view and perform laser treatments on a patient s retina. It allows binocular visualization of the peripheral retina and can be used to evaluate and treat patients.

    FDA Recall
    Terminated ·Iridex Corporation·Product code GEX·February 27, 2018

    Remel BactiSwab NPG Collection and Transport System, Sterile, 100 swab units/box, Catalog 12300. The firm name on the label is Remel, Lenexa, KS. Collection and transportation of clinical specimens to the laboratory for microbiological examination when swab collection is appropriate.

    FDA Recall
    Terminated ·Remel, Inc·Product code LIO·May 7, 2009

    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: 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

    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

    THERMI250 Radiofrequency System. Intended to provide heating for the purpose of elevating tissue temperature for selected medical conditions.

    FDA Enforcement
    Class II ·Terminated·Bios S.r.l.·November 8, 2017

    Multirall(TM) 200Liko Strap Gripper P/N 3136250 overhead lift for patient transfer situations.

    FDA Enforcement
    Class II ·Terminated·Liko AB·October 24, 2018

    UNO 100 Patient Lift

    FDA Recall
    Terminated ·Liko, Inc.·Product code FSA·November 14, 2005

    UNO 100 EM/EE Patient Lift

    FDA Recall
    Terminated ·Liko, Inc.·Product code FNG·September 24, 2004

    Liko Universal Sling Bar 450 Quick Release Hook (QRH) Product Number: 3156085

    FDA Recall
    Terminated ·Liko, Inc.·Product code FRW·June 13, 2007

    UNO 102 Patient Lift

    FDA Recall
    Terminated ·Liko, Inc.·Product code FSA·November 14, 2005

    Liko Universal Slingbar 450 (aluminum) used with the Viking L Patient Lift

    FDA Recall
    Terminated ·Liko, Inc.·Product code FSA·January 9, 2006

    Sabina I and II EM/EE Patient Lift

    FDA Recall
    Terminated ·Liko, Inc.·Product code FNG·September 24, 2004

    SABINA I and SABINA II Patient Lift

    FDA Recall
    Terminated ·Liko, Inc.·Product code FSA·November 14, 2005

    Liko Universal Slingbar 450 (aluminum) used with the Viking M Patient Lift

    FDA Recall
    Terminated ·Liko, Inc.·Product code FSA·January 9, 2006

    UNO 102 EM/EE/ES Patient Lift

    FDA Recall
    Terminated ·Liko, Inc.·Product code FNG·September 24, 2004