Medical Device Manufacturer · US , Mchenry , IL

O.R. Specialties, Inc. - FDA 510(k) Cleared Devices

14 submissions · 14 cleared · Since 1981

14

Total

14

Cleared

0

Denied

FDA 510(k) Regulatory Record - O.R. Specialties, Inc. Ophthalmic ✕

9 devices

1-9 of 9

Cleared Apr 06, 1994

PHACO NEEDLES 1000-R & 1000-O NEEDLES

Ophthalmic · 624d

Cleared Aug 02, 1993

DISPOSABLE SCLERAL PLUGS

Ophthalmic · 265d

Cleared Aug 18, 1992

POLLY'S VITREOUS SCISSORS J-225-S

Ophthalmic · 91d

Cleared Jul 02, 1992

LEWICKY O.R.S. TUBING

Ophthalmic · 55d

Cleared Dec 09, 1991

POLLY'S CUTTER J-225

Ophthalmic · 90d

Cleared Aug 03, 1989

JAMES SURGICAL SYSTEM J1000

Ophthalmic · 197d

Cleared May 26, 1989

JUMPER PACK #203

Ophthalmic · 98d

Cleared May 26, 1989

VITRECTOMY PACK #J120

Ophthalmic · 81d

Cleared Mar 07, 1988

C-MATE #CMU 1001

Ophthalmic · 60d