115 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Advantage/Advantage Fit Delivery Device, Lynx Delivery Device, Obtryx Delivery Device (Curved & Halo), Obtryx II Delivery Device (Curved & Halo), Solyx SIS Delivery Device
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
ANTERIOR APPROACH HIP SURGERY INSTRUMENTS
FDA 510(k)
FDA Class 3
·Orthopedic
NOVAPORT ONE VASCULAR ACCESS CANNULA
FDA 510(k)
FDA Class 2
·Cardiovascular
D.A.S.H. DOMETIP DOUBLE LUMEN SPHINCTEROTOME
FDA Adverse Event
Injury
·COOK ENDOSCOPY·Product code KNS·July 19, 2021
UTS PRECURVED ULTRA TAPER SPHINCTEROTOME
FDA Adverse Event
Malfunction
·COOK ENDOSCOPY·Product code KNS·April 29, 2021
TRI-TOME PC TRIPLE LUMEN SPHINCTEROTOME
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC·Product code KNS·May 12, 2022
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 17, 2013
PENTA 3MM LEAD, 60 CM
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·July 20, 2011
ACCU-CHEK COMPACT TEST DRUM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·September 19, 2008
AORTIC EXCLUDER AAA ENDOPROSTHESIS (LOW PROFILE)
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code MIH·October 30, 2018
AORTIC MOLDING AND OCCLUSION BALLOON CATHETER (MOB)
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code DQY·April 3, 2020
AORTIC MOLDING AND OCCLUSION BALLOON CATHETER (MOB)
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code DQY·August 26, 2019
AORTIC MOLDING AND OCCLUSION BALLOON CATHETER (MOB)
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code DQY·September 26, 2018
AORTIC MOLDING AND OCCLUSION BALLOON CATHETER (MOB)
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code DQY·February 4, 2020
AORTIC MOLDING AND OCCLUSION BALLOON CATHETER (MOB)
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code DQY·July 9, 2019
AORTIC MOLDING AND OCCLUSION BALLOON CATHETER (MOB)
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code DQY·July 3, 2019
AORTIC MOLDING AND OCCLUSION BALLOON CATHETER (MOB)
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code DQY·October 12, 2019
AORTIC MOLDING AND OCCLUSION BALLOON CATHETER (MOB)
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code DQY·August 7, 2019
AORTIC MOLDING AND OCCLUSION BALLOON CATHETER (MOB)
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code DQY·February 11, 2020
UTS PRECURVED ULTRA TAPER SPHINCTEROTOME
FDA Adverse Event
Malfunction
·COOK ENDOSCOPY·Product code KNS·November 23, 2020