9 results
·
24ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
The Simple Locking Intramedullary (Slim) System
FDA 510(k)
FDA Class 2
·Orthopedic
Symetri Clear
FDA UDI
ORMCO CORPORATION·00889989083118·L5R SYMETRI CLEAR MCLAUGHLIN, BENNETT & TREVISI...
NEO-SERVO I
FDA 510(k)
FDA Class 2
·General Hospital
PENTAX ED-3490TK, VIDEO DUODENOSCOPE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
GRANUFLO
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·October 21, 2014
RACK Ø6.5/7.3
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HWC·June 27, 2013
TECNIS
FDA Adverse Event
Injury
·ABBOTT MEDICAL OPTICS·Product code HQL·August 5, 2011
PENTAX
FDA Adverse Event
Injury
·HOYA CORP.·Product code FDT·July 24, 2015
TrueBeam Radiotherapy Delivery System version 2.0 and 2.5 EDGE Radiotherapy Delivery System version 2.0 and 2.5 Product Usage: The TrueBeam delivery systems are intended to provide radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems·October 10, 2018