9 results
·
18ms
·
Sources: EU EUDAMED, US FDA
BIOFEEDBACK-TRAINING INSTRUMENT
FDA 510(k)
FDA Class 2
·Neurology
LEONE SPA
FDA UDI
LEONE SPA·08033707029076·WEB 1ST MOLAR BANDS n.UL 29
TSRH® Spinal System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00673978050256·ROD 830-529 DANEK UNIT 5.5MM L29CM
LEGEND (BRAND) NITRILE POWDER-FREE PATIENT EXAMINATION GLOVE
FDA 510(k)
FDA Class 1
·General Hospital
RAUMEDIC-PTO-MONITORING-SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·May 23, 2014
M2A-MAGNUM MOD HD SZ 52MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·November 13, 2012
DURATA STS OPTIM ACTIVE FIXATION, SJ4 CONNECTOR
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·September 10, 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