97 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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NANOCROSS EITE 0.014 OVER-THE-WIRE PTA BALLOON DILATATION CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
Responsive Orthopedics Total Knee Arthroplasty System
FDA UDI
RESPONSIVE ORTHOPEDICS, LLC·00841973101420·Poly Insert MPCS, Size 1R, 18mm
MODIFICATION TO CD HORIZON SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
ACTIVON TULLE
FDA 510(k)
FDA Unclassified
·Unknown
Widex
FDA UDI
Widex A/S·05706069886610·WIDEX MOMENT MRB0 (Tech Black ) 440, RIC 10
Widex
FDA UDI
Widex A/S·05706069812602·Widex EVOKE E-PA (Tech Black ) 440, RC coil
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
ARCHITECT C8000 SYSTEM
FDA Adverse Event
Malfunction
·ABBOTT MANUFACTURING, INC.·Product code JJE·June 4, 2010
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
LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET
FDA Adverse Event
Injury
·COOK VANDERGRIFT INC·Product code DRE·September 14, 2020
LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET
FDA Adverse Event
Injury
·COOK VANDERGRIFT INC·Product code DRE·June 29, 2022