20 results
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26ms
·
Sources: EU EUDAMED, US FDA
OTE BIOMEDICAL #1296 - 16 CHAN. RECORD
FDA 510(k)
FDA Class 2
·Neurology
STRUCTUR 3
FDA 510(k)
FDA Class 2
·Dental
PROXIMATE AND ENDOPATH LINEAR CUTTERS AND STAPLERS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PROXIMATE RELOADABLE LINEAR CUTTER WITH SAFETY LOCK-OUT
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY, INC.·Product code GAG·March 22, 2006
ENDOPATH ETS45 ENDOSCOPIC LINEAR CUTTER - 3.5MM
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, INC.·Product code KOG·June 16, 2006
ENDOPATH ETS FLEX45 ENDOSCOPIC ARTICULATING LINEAR
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, INC. (CINCINNATI)·Product code GDW·June 13, 2006
ENDOPATH ETS FLEX45 ENDOSCOPIC ARTICULATING LINEAR
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, INC.(CINCINNATI)·Product code GCJ·June 8, 2006
ENDOPATH ETS FLEX45 ENDOSCOPIC ARTICULATING LINEAR
FDA Adverse Event
Malfunction
·ETHICON ENDO SURGERY, INC. (CINCINNATI)·Product code GCJ·June 19, 2006
ENDOPATH ETS FLEX45 ENDOSCOPIC ARTICULATING LINEAR CUTTER
FDA Adverse Event
Malfunction
·ETHICON ENDO SURGERY, INC.(CINCINNATI)·Product code GCJ·June 8, 2006
45MM ARTICING LNR CUTR/BLUE RLD
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY, INC.·Product code GCJ·December 21, 2005
ENDO LINEAR CUTTERS-ETS45MM
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, INC.(CINCINNATI)·Product code KOG·June 8, 2006
ENDOPATH ETS-FLEX45 ARTICULATING ENDOSCOPIC LINEAR
FDA Adverse Event
Malfunction
·ETHICON ENDO SURGERY, INC.(CINCINNATI)·Product code GDW·June 15, 2006
ENDOPATH ETS45 ENDOSCOPIC LINEAR CUTTER - 2.5 MM -
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY, INC.(CINCINNATI)·Product code KOG·October 21, 2005
ETS 45 ENDO LINEAR CUTTER BL
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, INC.(CINCINNATI)·Product code KOG·December 19, 2005
ALARIS PUMP MODULE ADMIN SET
FDA Adverse Event
Malfunction
·CAREFUSION CORP·Product code FPA·April 30, 2014
OT DELICA LANCING DEVICE
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·November 6, 2012
IMMULITE 2500
FDA Adverse Event
Other
·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code JJQ·August 27, 2010
ENDOPATH ETS FLEX45 ENDOSCOPIC ARTICULATING LINEAR CUTTER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, INC.(CINCINNATI)·Product code GDW·June 8, 2006
ENDOPATH ETS45 ENDOSCOPIC LINEAR CUTTER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, INC.(CINCINNATI)·Product code KOG·June 8, 2006
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