26 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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INJEX NEEDLE-FREE INJECTION SYSTEM; ROJEX NEEDLE-FREE INJECTION SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
BIOSENSORS CENTRAL VENOUS CATHETER KITS
FDA 510(k)
FDA Class 2
·General Hospital
ULNAR HEAD IMPLANT
FDA 510(k)
FDA Class 2
·Orthopedic
ZILVER 635 BILIARY SELF EXPANDING METAL STENT
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FGE·December 17, 2018
ZILVER BILIARY SELF-EXPANDING STENT
FDA Adverse Event
Injury
·COOK IRELAND LTD·Product code FGE·March 5, 2020
ZILVER 635 BILIARY SELF EXPANDING METAL STENT
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FGE·September 26, 2018
ZILVER 635 BILIARY SELF EXPANDING METAL STENT
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FGE·August 24, 2018
ZILVER 635 BILIARY SELF EXPANDING METAL STENT
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FGE·August 24, 2018
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·January 24, 2024
EMAX 2 PLUS MOTOR
FDA Adverse Event
Malfunction
·THE ANSPACH EFFORT, INC.·Product code HBC·March 18, 2013
RENEGADE HI-FLO MICROCATHETER
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - CORK·Product code KRA·March 16, 2011
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC.·Product code LFR·May 30, 2007
INTROCAN SAFETY®
FDA Adverse Event
Injury
·B BRAUN MELSUNGEN AG·Product code FOZ·April 1, 2025
Stryker End Cap T2 Tibia +10 mm Catalog Number: 18220010S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
FDA Enforcement
Class II
·Terminated·Stryker GmbH·June 24, 2020
ZILVER 635 BILIARY SELF EXPANDING METAL STENT
FDA Adverse Event
Injury
·COOK IRELAND LTD·Product code FGE·October 11, 2017
ZILVER 635 BILIARY SELF EXPANDING METAL STENT
FDA Adverse Event
Injury
·COOK IRELAND LTD·Product code FGE·October 11, 2017
ZILVER 635 BILIARY SELF EXPANDING METAL STENT
FDA Adverse Event
Injury
·COOK IRELAND LTD·Product code FGE·October 11, 2017
INTROCAN SAFETY®
FDA Adverse Event
Injury
·B BRAUN MELSUNGEN AG·Product code FOZ·August 11, 2025
ZILVER 635 BILIARY SELF EXPANDING METAL STENT
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FGE·August 2, 2018
ZILVER 635 BILIARY SELF EXPANDING METAL STENT
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FGE·March 5, 2020