26 results
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37ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ALL SILICONE FOLEY CATHETER, 2-WAY, 3-WAY, WITH TEMPERATURE SENSOR
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523137015·Ti-6Al-4V ALIF Implant 42 X 32, 15mm Height 22°...
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523137039·Ti-6Al-4V ALIF Implant 42 X 32, 19mm Height 22°...
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523137046·Ti-6Al-4V ALIF Implant 42 X 32, 21mm Height 22°...
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523137022·Ti-6Al-4V ALIF Implant 42 X 32, 17mm Height 22°...
PASS SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
MODIFICATION TO EDI VERIS SYSTEM
FDA 510(k)
FDA Class 2
·Ophthalmic
RESONANCE STENT SET
FDA Adverse Event
Injury
·COOK IRELAND LTD·Product code FAD·December 13, 2018
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·March 17, 2025
RESONANCE STENT SET
FDA Adverse Event
Injury
·COOK IRELAND LTD·Product code FAD·October 31, 2018
HEARTSTART XL
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·March 28, 2013
BLAKE DRAIN
FDA Adverse Event
Malfunction
·ETHICON,INC·Product code KOG·April 19, 2011
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR REDWOOD CITY·Product code MGB·June 20, 2008
Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x50 mm Catalog Number: 18965050S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
FDA Enforcement
Class II
·Terminated·Stryker GmbH·June 24, 2020
RESONANCE STENT SET
FDA Adverse Event
Injury
·COOK IRELAND LTD·Product code FAD·October 6, 2023
RESONANCE STENT SET
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FAD·July 25, 2018
RESONANCE STENT SET
FDA Adverse Event
Injury
·COOK IRELAND LTD·Product code FAD·May 29, 2015
RESONANCE STENT SET
FDA Adverse Event
Injury
·COOK IRELAND LTD·Product code FAD·October 11, 2018
RESONANCE STENT SET
FDA Adverse Event
Injury
·COOK IRELAND LTD·Product code FAD·November 22, 2018
RESONANCE STENT SET
FDA Adverse Event
Injury
·COOK IRELAND LTD·Product code FAD·September 27, 2023