10 results
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28ms
·
Sources: EU EUDAMED, US FDA
RESPIRONICS VENTEASY
FDA 510(k)
FDA Class 2
·Anesthesiology
OSTEOFIL DEM PASTE
FDA Adverse Event
Injury
·REGENERATION TECHNOLOGIES, INC.·Product code MQV·October 19, 2007
ZywieAI Software Library
FDA 510(k)
FDA Class 2
·Cardiovascular
IV ADMINISTRATION SET B400 SP
FDA 510(k)
FDA Class 2
·General Hospital
EVIS EXERA III COLONOVIDEOSCOPE
FDA Adverse Event
Malfunction
·AIZU OLYMPUS CO., LTD.·Product code FDF·October 15, 2025
GESCO
FDA Adverse Event
Malfunction
·UTAH MEDICAL PRODUCTS, INC.·Product code FKO·October 6, 2012
TANDEM T:SLIM INSULIN DELIVERY SYSTEM
FDA Adverse Event
Injury
·TANDEM DIABETES·Product code LZG·May 19, 2014
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·June 12, 2015
EV3 Pipeline Flex Embolization Device with Flex Shield Technology
FDA Enforcement
Class I
·Ongoing·Micro Therapeutics Inc,·September 15, 2021
Pinnacle Cups, Part numbers 121701048 121701050 121701052 121701054 121701056 121701058 121701060 121701062 121711048 121711052 121712050 121712052 121712056 121722048 121722050 121722052 121722054 121722056 121722058 121722060 121722062 121731048 121731050 121731052 121731054 121731056 121731058 121731060 121731062 121732048 121732050 121732052 121732054 121732056 121732058 121732060 121732062 121732064 - Product Usage: The PINNACLE CUP devices are part of the Pinnacle Hip Solution for the anatomic reconstruction of the hip joint, which promotes prosthetic joint load and function.
FDA Enforcement
Class II
·Terminated·DePuy Orthopaedics, Inc.·January 13, 2021