7,457 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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FORSURE IFOB DUEL SAMPLE FECAL OCCULT BLOOD TEST DEVICE (FOR PROFESSIONAL AND HOME USE); (FOR PROFESSIONAL); (FOR HOME T
FDA 510(k)
FDA Class 2
·Hematology
PASS SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
ZEUS ROBOTIC SURGICAL SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
POWER LOAD
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FPO·April 23, 2013
CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code KRH·May 1, 2011
IDENTITY SR
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DXY·July 11, 2008
Model Number ASHA4730-01: Ambient HipVac 50 Wand with Integrated Finger Switches and Model Number ASHA5050-01: Ambient KVac Wand with Integrated Finger Switches. The Wands are indicated for the resection, ablation, and coagulation of soft tissue, and hemostasis of blood vessels in arthroscopic and orthopedic procedures.
FDA Enforcement
Class II
·Terminated·ArthroCare Medical Corporation·December 17, 2014
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code NBW·October 15, 2010
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·January 16, 2012
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·March 19, 2012
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·March 19, 2012
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·January 17, 2012
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·January 30, 2012
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·January 23, 2012
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·February 14, 2012
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·February 29, 2012
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·January 9, 2012
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·March 16, 2012
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·March 30, 2012
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·March 30, 2012