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
2353–2376 of 5,110
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Oct 25, 1995
SUNGLASSES
K954639 · HQY
Walmart Stores
Ophthalmic · 15d
Cleared Oct 19, 1995
INFINITECH HIGH INTENSITY XENON LIGHT SOURCE SYSTEM
K951627 · MPA
Infinitech, Inc.
Ophthalmic · 195d
Cleared Oct 17, 1995
BOBES SLIT LAMP
K945445 · HJO
Bobes S.A.
Ophthalmic · 344d
Cleared Oct 17, 1995
TRI-STAR UNIVERSAL I/A PHACO PAK
K953359 · HQC
Tri-Star Ophthalmic
Ophthalmic · 92d
Cleared Oct 13, 1995
PRECISIONIST THIRTY THOUSAND
K953447 · HQC
Paradigm Medical Industries, Inc.
Ophthalmic · 88d
Cleared Oct 12, 1995
IOLAB.SITE CD PHACOEMULSIFICATION MODULE
K944993 · HQC
Chiron Vision Corp.
Ophthalmic · 365d
Cleared Oct 12, 1995
VISITEC COLLAR BUTTON CATHETER {GRIFFITHS}
K953394 · LZU
Visitec Co.
Ophthalmic · 87d
Cleared Oct 05, 1995
IOLAB/SITE PERISTALTIC MODULE
K944995 · HQC
Chiron Vision Corp.
Ophthalmic · 358d
Cleared Oct 05, 1995
OPHTA SIL- PUNCTAL PLUGS (MODIFICATION)
K954094 · LZU
G.W.B. Intl., Ltd.
Ophthalmic · 42d
Cleared Oct 03, 1995
SPECTACLE SUN GLASSES (NON PRESCRIPTION)
K954173 · HQY
Monte Carlo Eyewear, Inc.
Ophthalmic · 28d
Cleared Oct 02, 1995
INFINITECH LIGHTED INFUSION CANNULA
K946136 · MPA
Surgical Technologies, Inc.
Ophthalmic · 290d
Cleared Sep 27, 1995
904 SLIT LAMP
K953965 · HJO
Clement Clarke, Inc.
Ophthalmic · 36d
Cleared Sep 26, 1995
VISTAKON MULTIFOCAL (ETAFILCON A) CONTACT LENS
K953804 · LPL
Vistakon, Johnson & Johnson Vision...
Ophthalmic · 49d
Cleared Sep 14, 1995
NIDEK MODEL GYC-1500 AND GYC-2000
K951079 · HQF
Nidek, Inc.
Ophthalmic · 189d
Cleared Sep 14, 1995
STORZ MVS-3201 VITRECTOMY PROBE PACK
K953575 · HQE
Storz Instrument Co.
Ophthalmic · 45d
Cleared Sep 14, 1995
STORZ DP4505 VITREOUS MEMBRANE DISSECTOR
K953576 · HQE
Storz Instrument Co.
Ophthalmic · 45d
Cleared Sep 12, 1995
SUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
K952438 · HQY
Taiwan Eva Industrial Co., Inc.
Ophthalmic · 110d
Cleared Sep 12, 1995
VIEW POINT, DORION, RUDDY PROJECT, ULTRA FLEX, TRILLON, BAY BOY, SHIELD SKI,...
K952597 · HQZ
Point of View Optical Outlet, Inc.
Ophthalmic · 98d
Cleared Sep 12, 1995
SUNGLASSES & SPORT SUNGLASSES
K952963 · HQY
Wenzhou Winsor Optical International...
Ophthalmic · 78d
Cleared Sep 12, 1995
NIL
K953782 · HQY
Dehang Industries, Ltd.
Ophthalmic · 29d
Cleared Sep 12, 1995
REVERT SUNGLASSES & POLAR SUNGLASSES
K953920 · HQY
Bella Occhiali, Inc.
Ophthalmic · 22d
Cleared Sep 12, 1995
SUNGLASSES
K953947 · HQY
Wenzhou Yian Optical International,...
Ophthalmic · 27d
Cleared Sep 12, 1995
SUNGLASSES
K953989 · HQY
Morris & Sons Co.
Ophthalmic · 42d
Cleared Sep 12, 1995
YEOU NAN SUNGLASSES FRAME MFG, CO., LTD.
K954075 · HQY
Yo Nan Sunglasses Co., Ltd.
Ophthalmic · 13d