96 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ORTHOHELIX STAPLE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Gyrus ACMI
FDA UDI
Gyrus ACMI, LLC·00821925015784·RICHARDS FLUOROPLASTIC BUCKET HANDLE PROSTHESIS...
PEAN INSTESTINAL FORCEPS
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896024090·PEAN INSTESTINAL FORCEPS STRAIGHT TIP LONGITUDI...
HEART RATE TURBULENCE ANALYSIS TECHNOLOGIES
FDA 510(k)
FDA Class 2
·Cardiovascular
CURIEPACS (DICOM PACS SOFTWARE)
FDA 510(k)
FDA Class 2
·Radiology
T:SLIM X2, BASAL-IQ, MMOL/L
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code OZO·April 14, 2021
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·November 17, 2023
LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET
FDA Adverse Event
Death
·COOK VANDERGRIFT INC·Product code DRE·June 30, 2021
LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET
FDA Adverse Event
Death
·COOK VANDERGRIFT INC·Product code DRE·June 30, 2021
LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET
FDA Adverse Event
Injury
·COOK VASCULAR INC.·Product code DRE·January 8, 2018
LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET
FDA Adverse Event
Injury
·COOK VANDERGRIFT INC·Product code DRE·February 15, 2022
LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET
FDA Adverse Event
Injury
·COOK VASCULAR INC·Product code DRE·November 6, 2017
LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET
FDA Adverse Event
Injury
·COOK VASCULAR INC·Product code DRE·December 15, 2017
LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET
FDA Adverse Event
Injury
·COOK VASCULAR INC·Product code DRE·November 29, 2017
LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET
FDA Adverse Event
Injury
·COOK VASCULAR INC·Product code DRE·October 5, 2018
LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET
FDA Adverse Event
Death
·COOK VANDERGRIFT INC·Product code DRE·May 18, 2023
LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET
FDA Adverse Event
Injury
·COOK VANDERGRIFT INC·Product code DRE·October 25, 2022
LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET
FDA Adverse Event
Injury
·COOK VANDERGRIFT INC·Product code DRE·March 3, 2022
T:SLIM X2 INSULIN PUMP WITH INTEROPERABLE TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·June 29, 2020
LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET
FDA Adverse Event
Injury
·COOK VANDERGRIFT INC·Product code DRE·June 29, 2022