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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

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FDA Adverse Event
Malfunction ·LIFESCAN INC.·Product code NBW·January 16, 2012

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FDA Adverse Event
Malfunction ·LIFESCAN INC.·Product code NBW·March 19, 2012

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FDA Adverse Event
Malfunction ·LIFESCAN INC.·Product code NBW·March 19, 2012

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FDA Adverse Event
Malfunction ·LIFESCAN INC.·Product code NBW·January 17, 2012

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FDA Adverse Event
Malfunction ·LIFESCAN INC.·Product code NBW·January 30, 2012

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FDA Adverse Event
Malfunction ·LIFESCAN INC.·Product code NBW·January 23, 2012

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FDA Adverse Event
Malfunction ·LIFESCAN INC.·Product code NBW·February 14, 2012

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FDA Adverse Event
Malfunction ·LIFESCAN INC.·Product code NBW·February 29, 2012

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FDA Adverse Event
Malfunction ·LIFESCAN INC.·Product code NBW·January 9, 2012

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FDA Adverse Event
Malfunction ·LIFESCAN INC.·Product code NBW·March 16, 2012

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FDA Adverse Event
Malfunction ·LIFESCAN INC.·Product code NBW·March 30, 2012

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FDA Adverse Event
Malfunction ·LIFESCAN INC.·Product code NBW·March 30, 2012