96 results · 23ms · Sources: EU EUDAMED, 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