9 results
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26ms
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Sources: EU EUDAMED, US FDA
LIFESOUND ESOPHAGEAL STETHOSCOPE
FDA 510(k)
FDA Class 2
·Anesthesiology
Impulse 6000D
FDA UDI
FLUKE ELECTRONICS CORPORATION·00850540007119·Defibrillator Analyzer
HYDROTOWER ARTHROSCOPIC ADMINISTRATION TUBING SET, MODEL 7-460-05
FDA 510(k)
FDA Class 2
·General Hospital
PSYCHEMEDICS PHENCYCLIDINE EIA
FDA 510(k)
FDA Unclassified
·Unknown
CAPSUREFIX NOVUS MRI
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code NVN·October 31, 2012
EMAX 2 PLUS MOTOR
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code HBC·October 11, 2013
UTERINE ARTERY EMBOLIZATION
FDA Adverse Event
Injury
·Product code NAJ·August 18, 2010
Exactech Equinoxe CAGE GLENOID, CEMENTED, alpha curvature, Mates with: a) 38, 41, 44 head, Small, Item Number 314-13-02, b) 38, 41, 44 head, Medium, Item Number 314-13-03, c) 38, 41, 44 head, Large, Item Number 314-13-04; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
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