FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Ophthalmic ×
5,110 results
1969–1992 of 5,110
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Jan 20, 1998
PHACOPAK
K974719 · HQC
Paradigm Medical Industries, Inc.
Ophthalmic · 33d
Cleared Jan 16, 1998
ATRION MEDICAL PRODUCTS LACRIMAL INTUBATION SET
K973633 · OKS
Atrion Medical Products, Inc.
Ophthalmic · 183d
Cleared Jan 12, 1998
BAUSCH & LOMB2 SENSITIVE EYES MULTI-PURPOSE SOLUTION
K973921 · LPN
Bausch & Lomb, Inc.
Ophthalmic · 89d
Cleared Jan 12, 1998
SUNGLASSES
K974511 · HQY
Sun World Intl., Inc.
Ophthalmic · 42d
Cleared Jan 09, 1998
SUNGLASSES
K974441 · HQY
Hip Shing Fat Co., Ltd.
Ophthalmic · 45d
Cleared Jan 08, 1998
ATRION MEDICAL COATED LACRIMAL INTUBATION SET
K973872 · OKS
Atrion Medical Products, Inc.
Ophthalmic · 90d
Cleared Jan 08, 1998
AUTOMATED DISPOSABLE KERATOME (ADK)
K974004 · HNO
Lasersight Technologies, Inc.
Ophthalmic · 79d
Cleared Dec 19, 1997
PREFERENCE 60 AND PREFERENCE 60 TORIC
K963013 · LPL
CooperVision, Inc.
Ophthalmic · 507d
Cleared Dec 17, 1997
MPORT FOLDABLE LENS PLACEMENT SYSTEM
K970727 · MSS
Chiron Vision Corp.
Ophthalmic · 292d
Cleared Dec 17, 1997
BLINK GOLD EVELID WEIGHT (BG 06 THRU BG 28)
K971242 · MML
Ipax, Inc.
Ophthalmic · 259d
Cleared Dec 17, 1997
ULTRACELL SUCTION SPONGE
K972633 · HOZ
Ultracell Medical Technologies, Inc.
Ophthalmic · 156d
Cleared Dec 16, 1997
OCU-GUARD ORBITAL IMPLANT WRAP, SUPPLE OCU-GUARD ORBITAL IMPLANT WRAP
K973552 · MTZ
Bio-Vascular, Inc.
Ophthalmic · 88d
Cleared Dec 12, 1997
RETINAL CUBE
K973950 · HKI
Applied Spectral Imaging , Ltd.
Ophthalmic · 57d
Cleared Dec 08, 1997
SUNGLASSES
K973528 · HQY
Jeou Jeou Long Industrial Co., Ltd.
Ophthalmic · 82d
Cleared Dec 08, 1997
FRAG COMMANDER
K973749 · HQC
Scieran Technologies, Inc.
Ophthalmic · 68d
Cleared Dec 08, 1997
AL-47 TORIC (ISOFILCON) SOFT (TORIC) DAILY WEAR CONTACT LENS
K973847 · LPL
Martin Dalsing
Ophthalmic · 61d
Cleared Dec 08, 1997
AL-47 (POLYMACON) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT LENS (CLEAR &...
K973967 · LPL
Alden Optical Labs., Inc.
Ophthalmic · 52d
Cleared Dec 08, 1997
MULTI
K974414 · HQY
Morning Calm Corp.
Ophthalmic · 14d
Cleared Dec 02, 1997
ALCON MULTI-PURPOSE DISINFECTING SOLUTION ID 90746
K973332 · LPN
Alcon Laboratories
Ophthalmic · 89d
Cleared Dec 01, 1997
NON-PRESCRIPTION SUNGLASSES
K974179 · HQY
Taipan Optical Company , Ltd.
Ophthalmic · 25d
Cleared Nov 25, 1997
WHITTINGHAM ULTRACLEAN PHACO HANDPIECE
K972063 · HQC
William F. Whittingham
Ophthalmic · 175d
Cleared Nov 25, 1997
D.O.R.C. HEXON ILLUMINATION SYSTEM
K973229 · MPA
Dutch Ophthalmic USA, Inc.
Ophthalmic · 90d
Cleared Nov 24, 1997
BOSTON LIQUID ENZYMATIC CLEANER
K973217 · LPN
Polymer Technology Corp.
Ophthalmic · 89d
Cleared Nov 21, 1997
LUXSCOPE
K973193 · HQF
Luxtec Corp.
Ophthalmic · 88d