7 results
·
28ms
·
Sources: EU EUDAMED, US FDA
WAKO INSULIN TEST
FDA 510(k)
FDA Class 1
·Clinical Chemistry
S4 SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
VELOCITY ADVANTAGE
FDA 510(k)
FDA Class 2
·Ophthalmic
OXF TWIN-PEG CMNTD FEM MD PMA
FDA Adverse Event
Injury
·BIOMET U.K. LTD·Product code NRA·May 21, 2014
IMPLANT PDS3000M 6PK PILLAR PALATAL
FDA Adverse Event
Injury
·XOMED MFG JACKSONVILLE·Product code LRK·October 29, 2012
RADIOTHERAPEUTICS RF 3000 RADIOFREQUENCY GENERATOR
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code GEI·September 2, 2010
GE HC OEC 9900 Elite and GE OEC 9800 Fluoroscopes Snubber Boards are a PCB with a 70 amp fuse to provide fused protection of internal system components from the high voltage system components, such as the X-ray tube or High Voltage Transformer. System model number A349855, Snubber Board number 00-880405-03 rev 5. This product is used for image intensified fluoroscopic x-rays for interventional radiologic procedures.
FDA Enforcement
Class II
·Terminated·GE OEC Medical Systems, Inc·August 29, 2012