101 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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TRI AUTO MINI - ENDODEONTIC TREATMENT MOTORIZED HANDPIECE
FDA 510(k)
FDA Class 1
·Dental
2420 5 WAY STOPCOCK
FDA UDI
HANS RUDOLPH, INC.·00874750009534·2420B 5W STPCK 15/10.5MM
ULTRA THIN MALE LATEX CONDOM WITH SILICONE LUBRICANT
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
RHEA CUP
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
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
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·May 14, 2013
BRAVO
FDA Adverse Event
Malfunction
·GIVEN IMAGING LTD.·Product code FFT·May 26, 2011
HARMONIC ACE 23 CM
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC·Product code LFL·August 11, 2008
MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C55¿ S61CM D66CM GLOBALCatalog # 990061-055-000 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.
FDA Enforcement
Class II
·Terminated·Oscor, Inc.·December 28, 2016
U BY KOTEX SLEEK
FDA Adverse Event
Malfunction
·K-C AFC MANUFACTURING, S. DE R.L. DE C.V·Product code HEB·August 31, 2018
UTS PRECURVED ULTRA TAPER SPHINCTEROTOME
FDA Adverse Event
Malfunction
·COOK ENDOSCOPY·Product code KNS·November 23, 2020
TRI-TOME PC TRIPLE LUMEN SPHINCTEROTOME
FDA Adverse Event
Malfunction
·COOK ENDOSCOPY·Product code KNS·December 31, 2020
D.A.S.H. DOMETIP DOUBLE LUMEN SPHINCTEROTOME
FDA Adverse Event
Malfunction
·COOK ENDOSCOPY·Product code KNS·August 27, 2020
TRI-TOME PC TRIPLE LUMEN SPHINCTEROTOME
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC·Product code KNS·May 20, 2024
TRI-TOME PC PROTECTOR
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC·Product code KNS·May 12, 2022
TRI-TOME PC TRIPLE LUMEN SPHINCTEROTOME
FDA Adverse Event
Injury
·COOK ENDOSCOPY·Product code KNS·November 18, 2021
TRI-TOME PC TRIPLE LUMEN SPHINCTEROTOME
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC·Product code KNS·May 21, 2024
COTTON CANNULATOME
FDA Adverse Event
Death
·COOK ENDOSCOPY·Product code KNS·October 14, 2021