10,000 results
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37ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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KOH Cup Sterilization Tray (KCT)
FDA UDI
Coopersurgical, Inc.·00888937014778·KOH Cup Sterilization Tray (KCT)
LupoTek KCT
FDA UDI
R 2 DIAGNOSTICS, INC.·10859394006146·Screening test for LA 250 DET
LUPOTEK KCT
FDA 510(k)
FDA Class 2
·Hematology
PERIPHERAL VASCULAR SHEATH TUNNELER
FDA Adverse Event
Malfunction
·BARD PERIPHERAL VASCULAR, INC.·Product code KCT·July 25, 2024
100 ft roll of tubing inside a cardboard box. Medical devices are sealed into the tubes prior to ethylene oxide sterilization. Tube maintains sterility of the enclosed medical devices until opened.
FDA Enforcement
Class III
·Terminated·Steris Corporation·September 12, 2012
STERILCONTAINER
FDA Adverse Event
Malfunction
·AESCULAP, INC.·Product code KCT·September 28, 2015
STERRAD TYVEK POUCH
FDA Adverse Event
Malfunction
·ADVANCED STERILIZATION PRODUCTS·Product code KCT·March 12, 2009
STERILCONTAINER PRIMELINE LID
FDA Adverse Event
Malfunction
·AESCULAP, INC.·Product code KCT·May 27, 2014
CARDIAC CATH PACK
FDA Adverse Event
Malfunction
·CARDINAL HEALTH MEDICAL PRODUCTS & SERVICES·Product code KCT·February 13, 2004
STERRAD STERILIZATION POUCH
FDA Adverse Event
Malfunction
·ADVANCED STERILIZATION PRODUCTS·Product code KCT·March 4, 2010
STERRAD STERILIZATION POUCH
FDA Adverse Event
Malfunction
·ADVANCED STERILIZATION PRODUCTS·Product code KCT·June 30, 2010
GRAFTMASTER III SYSTEM TRAY
FDA Adverse Event
Malfunction
·SMITH & NEPHEW, INC.·Product code KCT·August 21, 2015
SURGICAL STERILE WRAPPER
FDA Adverse Event
Malfunction
·KIMBERLY CLARK·Product code KCT·December 20, 2012
JARIT DISPOSABLE FILTERS
FDA Adverse Event
Malfunction
·INTEGRA YORK, PA INC.·Product code KCT·June 21, 2021
AESCULAP JS CONTAINER
FDA Adverse Event
Malfunction
·AESCULAP, INC.·Product code KCT·June 1, 2021
AV SHEATH TUNNELER
FDA Adverse Event
Malfunction
·BARD PERIPHERAL VASCULAR, INC.·Product code KCT·December 3, 2021
COMPLETE SURGICAL TRAY
FDA Adverse Event
Injury
·IMPLANT DIRECT SYBRON MANUFACTURING LLC·Product code KCT·May 14, 2022
STEAM STER LOCKS ORANGE
FDA Adverse Event
Malfunction
·AESCULAP INC.·Product code KCT·December 8, 2021
FLEX OSTEOTOME DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·DEPUY ORTHOPAEDICS INC US·Product code KCT·June 14, 2022
HEAT SEAL STERILIZATION POUCH
FDA Adverse Event
Malfunction
·CARDINAL HEALTH·Product code KCT·April 30, 2012