7 results
·
18ms
·
Sources: EU EUDAMED, US FDA
MINIM. ESSENTIAL MED. EAGLE M4144 W/
FDA 510(k)
FDA Class 1
·Hematology
CAAS A-Valve
FDA 510(k)
FDA Class 2
·Radiology
ANTI-I.V. ENTERAL FEEDING SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
HEARTSTART ONSITE
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·March 13, 2014
PRECISION®
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·November 21, 2012
ENDOPATH** XCEL* BLADELESS TROCAR WITH STABILITY SLEEVE
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GCJ·September 23, 2010
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