8 results
·
27ms
·
Sources: EU EUDAMED, US FDA
ANKLE-FOOT CAST/SPLINT
FDA 510(k)
FDA Class 1
·Physical Medicine
DEVINE SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
MAMMOSITE RADIATION THERAPY SYSTEM (RTS) TRAY, MAMMOSITE HDR AFTERLOADER ACCESSORIES TRAY
FDA 510(k)
FDA Class 2
·Radiology
TPRLC 133 MP TYPE1 PPS HO 18.0
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·August 8, 2018
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·May 15, 2014
CAPSURE SENSE
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·October 31, 2012
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC. USA·Product code LFR·October 23, 2007
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