8 results
·
27ms
·
Sources: EU EUDAMED, US FDA
POLY-WIRE PISTON
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
KEITH A-GAURD
FDA 510(k)
FDA Class 1
·General Hospital
UTS ELECTRICAL MUSCLE STIMULATION DEVICE-PGS 1500
FDA 510(k)
FDA Class 2
·Physical Medicine
PFC SIGMARP STB TB IN 4 22.5
FDA Adverse Event
Injury
·DEPUY IRELAND ? REG. # 9616671·Product code NJL·February 6, 2013
MODEL NOT SPECIFIED
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OZO·July 18, 2014
DAILY ACTIVITY ASSIST DEVICE
FDA Adverse Event
Malfunction
·FOSHAN R. POON MEDICAL PRODUCTS CO., LTD.·Product code ILS·December 9, 2013
OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021
TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·May 20, 2015