HNC · Class I · 21 CFR 886.4350

FDA Product Code HNC: Specula, Ophthalmic

Leading manufacturers include V. Mueller O.V. Baxter Healthcare Corp., Stephens Instruments and Howmedica Corp..

11
Total
11
Cleared
43d
Avg days
1976
Since

FDA 510(k) Cleared Specula, Ophthalmic Devices (Product Code HNC)

11 devices
1–11 of 11
Cleared Nov 01, 2002
STEPHENS DISPOSABLE SPECULUM
K022836
Stephens Instruments
Ophthalmic · 66d
Cleared Jul 15, 1998
OCULOSTAT
K981235
Laser Center Dev. Corp.
Ophthalmic · 103d
Cleared Dec 17, 1996
EYE FIXATION SPECULUM
K964289
Eyefix, Inc.
Ophthalmic · 50d
Cleared Oct 31, 1986
THORNTON TITANIUM SPECULUM (MODIFIED BARRAQUER)
K863989
Keeler Instruments, Inc.
Ophthalmic · 17d
Cleared Sep 25, 1986
OPHTHALMIC SURGICAL SPECULUM
K863664
Myocure, Inc.
Ophthalmic · 7d
Cleared Oct 05, 1984
VISITEC EYE SPECULUM
K843196
Visitec Co.
Ophthalmic · 52d
Cleared Jun 10, 1983
EYELID SPECULUM
K830430
Douglas C. Mckee & Co.
Ophthalmic · 121d
Cleared Aug 27, 1980
ASNIS GUIDED SCREW SYSTEMS
K801969
Howmedica Corp.
Ophthalmic · 8d
Cleared Nov 02, 1976
FELDSTEIN BLEPHAROPLASTY CLIP SHARP P
K760847
V. Mueller O.V. Baxter Healthcare Corp.
Ophthalmic · 18d
Cleared Nov 02, 1976
FELDSTEIN BLEPHAROPLASTY CLIP RECTANGU
K760848
V. Mueller O.V. Baxter Healthcare Corp.
Ophthalmic · 18d
Cleared Nov 02, 1976
FELDSTEIN BLEPHAROSTOMY CLIP SQUARE
K760849
V. Mueller O.V. Baxter Healthcare Corp.
Ophthalmic · 18d

About Product Code HNC - Regulatory Context