42 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CERCON CERAM S PORCELAIN
FDA 510(k)
FDA Class 2
·Dental
MODIFICATION TO PROVIDENT HIP SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
AMLUCK AUTOMATIC DIGITAL WRIST, BLOOD PRESSURE MONITOR AK-3000/AK-4000
FDA 510(k)
FDA Class 2
·Cardiovascular
TYVASO INHALATION SYSTEM
FDA Adverse Event
Malfunction
·UT GMBH·Product code CAF·March 26, 2013
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORP·Product code FRN·March 13, 2014
XPERT SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM
FDA Adverse Event
Malfunction
·ABBOTT VASCULAR SWITZERLAND·Product code FGE·March 28, 2008
CXI SUPPORT CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code KRA·May 12, 2017
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
CXI SUPPORT CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code KRA·August 25, 2017
CXI SUPPORT CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code KRA·August 8, 2017
CXI SUPPORT CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code KRA·March 7, 2017
CXI SUPPORT CATHETER
FDA Adverse Event
Injury
·COOK INC·Product code KRA·August 27, 2020
CXI SUPPORT CATHETER
FDA Adverse Event
Injury
·COOK INC·Product code KRA·April 24, 2019
CXI SUPPORT CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code KRA·April 18, 2019
CXI SUPPORT CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code KRA·July 25, 2018
CXI SUPPORT CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code KRA·April 12, 2017
CXI SUPPORT CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code KRA·January 15, 2020
CXI SUPPORT CATHETER
FDA Adverse Event
Injury
·COOK INC·Product code KRA·February 17, 2020
CXI SUPPORT CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code KRA·March 18, 2021
CXI SUPPORT CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code KRA·February 19, 2018