66 results
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17ms
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Sources: EU EUDAMED, US FDA
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FDA Recall
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Floppy Cronus Endovascular Guidewire, Length 300 cm (partial coat), Diameter 0.014 inch, Part Number 001-001232-4
FDA Recall
Terminated
·Stereotaxis Inc·Product code NFN·January 27, 2004
Cronus Endovascular Guidewire, Length 300 cm (partial coat), Diameter 0.014 inch, Part Number 001-001096-4
FDA Recall
Terminated
·Stereotaxis Inc·Product code NFN·January 27, 2004
Floppy Cronus Endovascular Guidewire, Length 180 cm (partial coat), Diameter 0.014 inch, Part Number 001-001232-3
FDA Recall
Terminated
·Stereotaxis Inc·Product code NFN·January 27, 2004
Cronus-1 Endovascular Guidewire, Length 210 cm (full coat), Diameter 0.014 inch, Part Number 001-001263-1
FDA Recall
Terminated
·Stereotaxis Inc·Product code NFN·January 27, 2004
Cronus Endovascular Guidewire, Length 210 cm (full coat), Diameter 0.014 inch, Part Number 001-001096-1
FDA Recall
Terminated
·Stereotaxis Inc·Product code NFN·January 27, 2004
Cronus Endovascular Guidewire, Length 210 cm (partial coat), Diameter 0.014 inch, Part Number 001-001096-3
FDA Recall
Terminated
·Stereotaxis Inc·Product code NFN·January 27, 2004
Chameleon PTA Balloon Catheter with Injection Port 5mm x 40mm x 75cm (CFN CH05-40-75US), 6mm x 40mm x 75cm (CFN CH06-40-75US), 7mm x 40mm x 75cm (CFN CH07-40-75US), 8mm x 40mm x 75cm (CFN CH08-40-75US), 9mm x 40mm x 75cm (CFN CH09-40-75US), 10mm x 40mm x 75cm (CFN CH10-40-75US), 12mm x 40mm x 75cm (CFN CH12-40-75US)
FDA Recall
Open, Classified
·Product code LIT·September 19, 2024
The Rapid fFN Specimen Collection Tube (PN: 71550-001) is a component of the Rapid fFN Specimen Collection kit (PN: 71738-001). The Collection Tube (PN: 71550-001) is manufactured by a third-party supplier, MML Diagnostics Packaging, and includes the transport tube, cap, and extraction buffer. Tubes are packaged into PN: 71738-00 at Hologic prior to kit release.
FDA Recall
Open, Classified
·Hologic, Inc.·Product code LIO·January 8, 2025
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
TourniKwik Tourniquet Set (CFN 79012)
FDA Recall
Open, Classified
·Medtronic Perfusion Systems·Product code GDJ·May 16, 2024
Enhanced Verify Evaluation Handset (CFN HH90130FA)
FDA Recall
Open, Classified
·Medtronic Neuromodulation·Product code EZW·April 3, 2025
Puritan Bennett 560 Ventilator, PB560, CFN 4096600
FDA Recall
Open, Classified
·Covidien Llc·Product code QOS·August 19, 2022
InPen App, Model/CFN Number: MMT-8061 (Android Users)
FDA Recall
Open, Classified
·Medtronic MiniMed, Inc.·Product code NDC·November 13, 2025
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
InPen App, CFN: MMT-8060 (iOS Users) and MMT-8061 (Android Users)
FDA Recall
Open, Classified
·Medtronic MiniMed, Inc.·Product code NDC·June 16, 2025
Medical Device Identification Cards associated with Sprint Quattro Lead, Product/CFN 6935M72
FDA Recall
Completed
·Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)·Product code NVY·November 8, 2021
Rapid for the TLiIQ(R) System, HOLOGIC(R), Catalog number: 01200Q
FDA Recall
Terminated
·Hologic, Inc.·Product code LKV·November 29, 2017