7 results
·
18ms
·
Sources: EU EUDAMED, US FDA
MYOMETER EMG BIOFEEDBACK DEVICE
FDA 510(k)
FDA Class 2
·Neurology
HA COATED LAG SCREW
FDA 510(k)
FDA Class 2
·Orthopedic
TMS 1000 TEMP. MONITOR & PROBES
FDA 510(k)
FDA Class 2
·General Hospital
OXIMAX N85 CAPNO/OXIMETER
FDA Adverse Event
Malfunction
·ORIDION -RX·Product code CCK·February 11, 2014
HEARTSTREAM FR2
FDA Adverse Event
Death
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·November 20, 2012
S-ROM HEAD FEMRL ZIRCONIA 28+0
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code LZO·September 28, 2010
Zimmer, Cuff Tourniquet Dual Hose Single Bladder Maroon Reprocessed by Sterilmed, Sterile EO, Rx only.
FDA Enforcement
Class II
·Terminated·STERILMED, INC.·December 16, 2015