9 results
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27ms
·
Sources: EU EUDAMED, US FDA
MEDTRONIC DUAL CHANNEL SPINAL CORD STIM
FDA 510(k)
FDA Class 2
·Neurology
AURADONICS
FDA UDI
AURADONICS INC.·00810033837227·LATEX ELASTICS 1/8" 3.5 oz. - AMBER, 100 bags o...
TheraFace LED
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
KODAK RADIATION ONCOLOGY SOFTWARE/ FOR ACR SYSTEMS
FDA 510(k)
FDA Class 2
·Radiology
STYLE 68 SALINE FILLED BREAST IMPLANT
FDA Adverse Event
Injury
·ALLERGAN (COSTA RICA)·Product code FWM·June 10, 2020
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·January 9, 2014
SPRINT QUATTRO SECURE
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·October 31, 2012
SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR
FDA Adverse Event
Injury
·DEXCOM, INC.·Product code MDS·August 16, 2010
Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head, Large, Item Number 314-13-14, c) 47, 50, 53 head, Extra Large, Item Number 314-13-15; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024