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
2305–2328 of 5,110
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Jan 25, 1996
MEDPOR OCULAR SCREW & ACCESSORIES
K954939 · HPZ
Porex Surgical, Inc.
Ophthalmic · 87d
Cleared Jan 11, 1996
MOONSHADES SUNGLASSES
K954659 · HQY
Blublocker Corp.
Ophthalmic · 93d
Cleared Jan 11, 1996
PHACO TIP
K954746 · HQC
U.S. Iol, Inc.
Ophthalmic · 87d
Cleared Jan 11, 1996
SUNGLASSES WITH IMPACT RESISTANT LENSES
K955572 · HQY
Diamond Mark International Co., Ltd.
Ophthalmic · 35d
Cleared Jan 05, 1996
GAMP & ASSOCIATES THREE FUNCTION DISPOSABLE MANIPULATOR
K952569 · HQR
Gamp & Assoc.
Ophthalmic · 214d
Cleared Jan 05, 1996
GAMP & ASSOCIATES DISPOSABLE FIBEROPTIC VISCOINJECTOR
K952581 · MPA
Gamp & Assoc.
Ophthalmic · 214d
Cleared Jan 05, 1996
GAMP & ASSOCIATES DISPOSABLE END IRRIGATING ENDOILLUMINATOR
K952585 · MPA
Gamp & Assoc.
Ophthalmic · 214d
Cleared Jan 04, 1996
DURASOFT FRESHLOOK UV COLORS
K954603 · LPL
Wesley Jessen Corp.
Ophthalmic · 92d
Cleared Jan 03, 1996
OP-2 (LOTIFOCON B) & OP-6 (LOTIFOCON C)
K952260 · HQD
Stellar Contact Lens, Inc.
Ophthalmic · 233d
Cleared Jan 03, 1996
KOWA SC-1200 PHOTO SLIT LAMP SYSTEM
K955442 · HKI
Kowa Optimed, Inc.
Ophthalmic · 36d
Cleared Jan 03, 1996
UNISUN
K955539 · HQY
Steven Chen
Ophthalmic · 29d
Cleared Jan 03, 1996
KMANZ II
K955611 · HQY
Gatorz LLC
Ophthalmic · 26d
Cleared Dec 26, 1995
RM001 REUSABLE
K953538 · HQC
American Optisurgical, Inc.
Ophthalmic · 151d
Cleared Dec 26, 1995
DM001 DISPOSABLE PACK
K953539 · HQC
American Optisurgical, Inc.
Ophthalmic · 151d
Cleared Dec 22, 1995
GAMP & ASSOC. DISPOSABLE ILL ENDOCULAR LASER PROBE
K954306 · HQB
Gamp & Assoc.
Ophthalmic · 98d
Cleared Dec 22, 1995
GAMP & ASSOC. DISPOSABLE ENDOOCULAR LASER PROBE
K954307 · HQB
Gamp & Assoc.
Ophthalmic · 98d
Cleared Dec 22, 1995
GAMP & ASSOC. DISPOSABLE ASPIRATING ENDOOCULAR LASER PROBE
K954308 · HQB
Gamp & Assoc.
Ophthalmic · 98d
Cleared Dec 21, 1995
MICROSTAAR INJECTOR MODELS MSI-TD & MSI-PD (MODIFICATION)
K954600 · KYB
Staar Surgical Co.
Ophthalmic · 87d
Cleared Dec 14, 1995
STORZ MICROFLOW PHACOEMULSIFICATION NEEDLE
K954340 · HQC
Storz
Ophthalmic · 87d
Cleared Dec 14, 1995
HANYANG SUNGLASSES
K955127 · HQY
Hanyang Industries, Inc.
Ophthalmic · 35d
Cleared Dec 11, 1995
METRO 55G TORIC & SPHERICAL
K953199 · LPL
Metrosoft, Inc.
Ophthalmic · 154d
Cleared Dec 08, 1995
CIRCUIT TREE PHACO HANDPIECE
K954237 · HQC
Circuit Tree
Ophthalmic · 88d
Cleared Dec 08, 1995
SURGIN GENISIS HANDPIECE
K954238 · HQC
Surgin Surgical Instrumentation, Inc.
Ophthalmic · 88d
Cleared Dec 08, 1995
U.S. IOL PHACO HANDPIECE
K954239 · HQC
U.S. Iol, Inc.
Ophthalmic · 88d