Medical Device Manufacturer · US , Manchester , VT

The Orvis Co., Inc. - FDA 510(k) Cleared Devices

9 submissions · 9 cleared · Since 1994

9

Total

9

Cleared

0

Denied

FDA 510(k) Regulatory Record - The Orvis Co., Inc. Ophthalmic ✕

9 devices

1-9 of 9

Cleared Mar 02, 1995

ORVIS KEY WEST SUNGLASSES

Ophthalmic · 20d

Cleared Aug 04, 1994

ORVIS DRIVING GLASSES

Ophthalmic · 34d

Cleared Aug 02, 1994

ORVIS LIGHT WEIGHT POLARIZED CLIP-ONS

Ophthalmic · 40d

Cleared Aug 02, 1994

ORVIS POLARIZED BI-FOCALS

Ophthalmic · 34d

Cleared Jul 25, 1994

ORVIS WORLD FINEST POLARIZED CLIP ONS

Ophthalmic · 32d

Cleared Jul 08, 1994

Ophthalmic · 80d

Cleared Jun 03, 1994

Ophthalmic · 56d

Cleared Mar 24, 1994

ORVIS RIVER GUIDE GLASSES

Ophthalmic · 62d

Cleared Mar 24, 1994

ORVIS MARQUESAS FISHING GLASSES

Ophthalmic · 58d