9 results
·
19ms
·
Sources: EU EUDAMED, US FDA
CLEAN-FLUSH
FDA 510(k)
FDA Class 1
·General Hospital
INTERACTIVE SBM 3.7MMDX13MML 3.0MM PLAT
FDA Adverse Event
Injury
·IMPLANT DIRECT SYBRON MANUFACT·Product code DZE·October 29, 2025
INTERACTIVE/ SWISHPLUS2 IMPLANT SYSTEM
FDA 510(k)
FDA Class 2
·Dental
HENKE SASS WOLF OF AMERICA NASOPHARYNGOSCOPE
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
DEPTH GAUGE FOR 1.3MM AND 1.5MM SCREWS
FDA Adverse Event
Malfunction
·SYNTHES JENNERSVILLE·Product code HTJ·May 23, 2014
GYNECARE GYNEMESH* PS
FDA Adverse Event
Injury
·ETHICON, INC.·Product code OTO·November 13, 2012
ACCU-CHEK FLEXLINK INFUSION SET
FDA Adverse Event
Malfunction
·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code FPA·September 3, 2010
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
Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018