Medical Device Manufacturer · US , Irvine , CA

Edwards Lifesciences, LLC - FDA 510(k) Cleared Devices

135 submissions · 129 cleared · Since 1979

Official Website

135

Total

129

Cleared

1

Denied

135 devices

126-135 of 135

Cleared Jun 20, 2003

EDWARDS LIFESCIENCES PERCUTANEOUS SHEATH INTRODUCERS WITH OLIGON MATERIAL

Cardiovascular · 86d

Cleared Apr 24, 2003

EDWARDS INTRODUCER SHEATH

Cardiovascular · 17d

Cleared Apr 17, 2002

EDWARDS MC TRICUSPID ANNULOPLASTY SYSTEM, MODEL 4900

Cardiovascular · 30d

Cleared Apr 11, 2002

AXILLARY ACCESS ARTERIAL CANNULA

Cardiovascular · 601d

Cleared Mar 08, 2002

EDWARDS LIFESCIENCES PERCUTANEOUS SHEATH INTRODUCERS WITH OLIGON MATERIAL

Cardiovascular · 88d

Cleared Mar 08, 2002

EDWARDS LIFESCIENCES SWAN-GANZ MONITORING CATHETER WITH OLIGON MATERIAL

Cardiovascular · 88d

Cleared Feb 27, 2002

LIFESTITCH SUTURING DEVICE

General & Plastic Surgery · 86d

Cleared Mar 26, 2001

FOGARTY VALVULOTOME, MODEL 700091

Cardiovascular · 292d

Cleared Aug 10, 2000

STEERABLE RETROGRADE CARDIOPLEGIA CANNULA WITH AND WITHOUT DURAFLO TREATMENT,...

Cardiovascular · 83d

Cleared Jul 12, 1979

SWAN-GANZ FLOW-DIRECTED CATHETER

Cardiovascular · 17d

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