Medical Device Manufacturer · US , Mchenry , IL

Coburn Optical Ind., Inc. - FDA 510(k) Cleared Devices

14 submissions · 14 cleared · Since 1978

14

Total

14

Cleared

0

Denied

FDA 510(k) Regulatory Record - Coburn Optical Ind., Inc. Ophthalmic ✕

12 devices

1-12 of 12

Cleared May 26, 1989

MAGNILINK SYSTEM 101

Ophthalmic · 51d

Cleared May 26, 1989

MAGNILINK SYSTEM 201

Ophthalmic · 51d

Cleared May 26, 1989

MAGNILINK SYSTEM 209

Ophthalmic · 51d

Cleared May 26, 1989

MAGNILINK SYSTEM 402/5

Ophthalmic · 51d

Cleared May 26, 1989

MAGNILINK SYSTEM 602

Ophthalmic · 51d

Cleared Aug 21, 1986

IRRIGATION & ASPIRATION/VITRECTOMY DEVICE

Ophthalmic · 73d

Cleared Oct 15, 1985

COBURN I/A SYSTEM

Ophthalmic · 60d

Cleared Oct 06, 1981

Ophthalmic · 41d

Cleared Feb 04, 1981

AUTOMATED PERIMETERS

Ophthalmic · 58d

Cleared Sep 09, 1980

BIOPHTAL CLINICAL ENDOTHELIAL MICROSCOPE

Ophthalmic · 50d

Cleared Jul 21, 1980

Ophthalmic · 55d

Cleared Nov 15, 1978

Ophthalmic · 75d