Medical Device Manufacturer · US , Kingston , NH

Dutch Ophthalmic USA, Inc. - FDA 510(k) Cleared Devices

10 submissions · 10 cleared · Since 1990

10

Total

10

Cleared

0

Denied

FDA 510(k) Regulatory Record - Dutch Ophthalmic USA, Inc. Ophthalmic ✕

9 devices

1-9 of 9

Cleared Oct 22, 2001

D.O.R.C. CRYOSTAR CRYOSURGICAL SYSTEM

Ophthalmic · 60d

Cleared Mar 12, 2001

D.O.R.C. HARMONY TOTAL TTC VITRECTOMY SYSTEM

Ophthalmic · 61d

Cleared Mar 03, 1999

D.O.R.C. HARMONY TOTAL VITRECTOMY SYSTEM

Ophthalmic · 126d

Cleared Nov 25, 1997

D.O.R.C. HEXON ILLUMINATION SYSTEM

Ophthalmic · 90d

Cleared Nov 07, 1997

D.O.R.C. SOLUX LIGHT SOURCE

Ophthalmic · 36d

Cleared Aug 29, 1996

D.O.R.C. MICRODIATHERMY SYSTEM

Ophthalmic · 87d

Cleared Apr 15, 1996

D.O.R.C. VFI/VFE SYSTEM

Ophthalmic · 175d

Cleared Jul 18, 1994

OPHTHALMIC CRYO UNIT

Ophthalmic · 173d

Cleared Jun 26, 1990

ECKHARDT TEMPORARY KERATOPROSTHESIS

Ophthalmic · 21d