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
3409–3432 of 5,110
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared May 01, 1991
OPHTA SIL (R), LACHRYMAL INTUBATION SETS
K911109 · OKS
G.W.B. Intl., Ltd.
Ophthalmic · 58d
Cleared Apr 26, 1991
SUNGLASSES MODEL #SP PROMO #1 AND SP PROMO #2
K910597 · HQY
Radix Group Intl.
Ophthalmic · 73d
Cleared Apr 26, 1991
DISPOSABLE IRRIGATING/ASPIRATING HANDPIECE
K910973 · HQE
Surgical Technologies, Inc.
Ophthalmic · 50d
Cleared Apr 25, 1991
COMPAC(TM) DIODE LASERS
K904699 · HQF
Hgm Medical Laser Systems, Inc.
Ophthalmic · 191d
Cleared Apr 10, 1991
LOW VISION ENHANCEMENT SYSTEM (LVES)
K910124 · HPG
Triangle Investments
Ophthalmic · 89d
Cleared Apr 10, 1991
OPTICAL FRAME
K910179 · HQZ
Australian Optical Co., Inc.
Ophthalmic · 85d
Cleared Apr 10, 1991
OPERAID SURGICAL DRAIN W/ CORNEAL SHIELDS
K910707 · HOZ
Jedmed Instrument Co.
Ophthalmic · 49d
Cleared Apr 08, 1991
SCITECH BI-MANUAL ADAPTER CLIPS
K910088 · HQQ
Scitech Industries Partnership
Ophthalmic · 89d
Cleared Mar 15, 1991
KRUPIN EYE VALVE WITH DISK
K905703 · KYF
Hood Laboratories
Ophthalmic · 85d
Cleared Mar 15, 1991
OPTICAL FRAME (HELEN,ARNOLD,VANA,BRUCE,MATT)
K910134 · HQZ
Kentucky Optical Co.
Ophthalmic · 65d
Cleared Mar 15, 1991
INTEGO
K910904 · HQY
Racal Health & Safety, Inc.
Ophthalmic · 10d
Cleared Mar 14, 1991
TRABECULO-SUPRACHOROIDAL SHUNT
K902296 · KYF
Visionex, Inc.
Ophthalmic · 296d
Cleared Mar 14, 1991
LACRIMAL PLUG
K905750 · LZU
Tamcenan Corp.
Ophthalmic · 80d
Cleared Mar 14, 1991
SUNGLASSES (NON-PRESCRIPTION)
K905864 · HQY
The Limited Stores, Inc.
Ophthalmic · 84d
Cleared Mar 14, 1991
SUNGLASSES/NON-PRESCRIPTION (LA GIARDINIERA)
K910125 · HQY
The Limited Stores, Inc.
Ophthalmic · 66d
Cleared Mar 14, 1991
SUNGLASSES, NON-PRESCRIPTION (ITALO CREMONA)
K910126 · HQY
The Limited Stores, Inc.
Ophthalmic · 66d
Cleared Mar 14, 1991
SUNGLASSES, NON-PRESCRIPTION (POLINELLI)
K910127 · HQY
The Limited Stores, Inc.
Ophthalmic · 66d
Cleared Mar 12, 1991
SUNGLASSES
K910329 · HOI
Cutler & Gross Sloan Optical , Ltd.
Ophthalmic · 46d
Cleared Mar 05, 1991
CRYSTAL FOCUS EMERALD LASER/SLT OPHF 0.6 ENDO HAND
K905453 · HQF
Douglas James Donaldson Compliance...
Ophthalmic · 90d
Cleared Mar 04, 1991
NEON RUBBER SUNGLASSES
K905183 · HQZ
Ha-Lo Advertising Specialties, Inc.
Ophthalmic · 105d
Cleared Mar 04, 1991
CANDELA DIODE TRABECULOPLASTY LASER DTL
K910612 · HQF
Candela Laser Corp.
Ophthalmic · 20d
Cleared Feb 26, 1991
SUNGLASSES
K902343 · HQY
Jasco Products Co., Inc.
Ophthalmic · 277d
Cleared Feb 26, 1991
VITREORETINAL INFUSION CANNULA
K904074 · HMX
Visitec Co.
Ophthalmic · 175d
Cleared Feb 26, 1991
J&B OPTICAL FRAMES
K910626 · HQZ
J & B Optical, Inc.
Ophthalmic · 14d