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
2281–2304 of 5,110
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Mar 28, 1996
SEESOFT (POLYMACON) SOFT (HYDROPHILIC) ASPHERIC CONTACT LENS
K960380 · LPL
Unilens Corp., USA
Ophthalmic · 62d
Cleared Mar 26, 1996
STORZ MVS 1011A DISPOSABLE FIBEROPTIC ENDOILLUMINATOR
K960007 · MPA
Storz
Ophthalmic · 84d
Cleared Mar 25, 1996
NOVALENS/NOVAWET SPHJERICAL & PERCEPTION & VANGUARD MULTIFOCAL &/OR BIFOCAL...
K955900 · HQD
Novavision, Inc.
Ophthalmic · 87d
Cleared Mar 25, 1996
TINTED OCU-FLEX 53 (OCCUFILCON B) SOFT HYDROPHILIC CONTACT LENS
K960291 · LPL
Ocu-Ease Optical Products, Inc.
Ophthalmic · 63d
Cleared Mar 21, 1996
ALCON SERIES 20000 LEGACY MACKOOL SYSTEM
K955789 · HQC
Alcon Laboratories
Ophthalmic · 90d
Cleared Mar 19, 1996
O-PERM 30 A RIGID GAS PERMEABLE CONTACT LENS
K954124 · HQD
Optical Polymer Research, Inc.
Ophthalmic · 200d
Cleared Mar 19, 1996
NON PRESCRIPTION SUN GLASSES
K960650 · HQY
Solovision Optical, Inc.
Ophthalmic · 78d
Cleared Mar 12, 1996
SUNGLASSES/EYEGLASS FRAMES
K960573 · HQY
Architectures
Ophthalmic · 29d
Cleared Mar 12, 1996
FABRIS LAN SUNGLASSES
K960786 · HQY
Fabris Lane Intl., Ltd.
Ophthalmic · 15d
Cleared Mar 12, 1996
D & K SUNGLASSES
K960797 · HQY
D&K Stores, Inc.
Ophthalmic · 14d
Cleared Mar 11, 1996
PALLIKARIS BRUSH
K960261 · HOG
Alcon Laboratories, Inc.
Ophthalmic · 53d
Cleared Mar 06, 1996
RITLENG BICAN.LACR.SETS/SELF THREAD. MONOKAS(CHG.IN STER.)
K955671 · OKS
G.W.B. Intl., Ltd.
Ophthalmic · 93d
Cleared Mar 04, 1996
STORZ OPHTHALMIC BIPOLAR CAUTERY INSTRUMENTS (D8200, D8201, D8203) AND...
K952151 · HQR
Storz
Ophthalmic · 301d
Cleared Mar 04, 1996
STORZ DP4800 DELUXE , STORZ DP4801 BASIC W/REFLUX, DP4801 BASIC POSTERIOR...
K954816 · HQE
Storz Instrument Co.
Ophthalmic · 136d
Cleared Mar 04, 1996
BUFFARD CREATION (SUNGLASSES)
K955933 · HQY
Buffard Creation Eurl
Ophthalmic · 69d
Cleared Mar 04, 1996
ARNET OR ARNETTE
K960530 · HQY
Arnet Optic Illusions
Ophthalmic · 27d
Cleared Mar 04, 1996
LANARD, RADIO SHADES, SUN SHADES, COOL SHADES, KOOL LOOPS, SOLAR SPEX, SHADE...
K960628 · HQY
Lanard Toys, Ltd.
Ophthalmic · 20d
Cleared Feb 16, 1996
JAMES KOREA OPTICAL FRAMES & SUNGLASSES
K960289 · HQY
James Korea Co., Ltd.
Ophthalmic · 25d
Cleared Feb 14, 1996
DAILY WEAR SOFT (HYDROPHILIC) CONTACT LENS
K953807 · LPL
Stephen A. Dunn, Inc.
Ophthalmic · 190d
Cleared Feb 12, 1996
MENTOR MERIDIAN PHACOEMULSIFICATION SYSTEM
K955245 · HQC
Mentor O & O, Inc.
Ophthalmic · 89d
Cleared Feb 09, 1996
SURGITRON
K955158 · HQR
Ellman Intl., Inc.
Ophthalmic · 88d
Cleared Jan 29, 1996
ZONG RONG SUNGLASSES
K955287 · HQY
Yuu Yeng Enterprise Co., Ltd.
Ophthalmic · 73d
Cleared Jan 29, 1996
ZONG RONG SUNGLASSES
K955441 · HQY
Zong Rong Glasses Ltd. Co.
Ophthalmic · 69d
Cleared Jan 29, 1996
PLASTIC FRAME, METAL FRAME, OPTICAL
K955695 · HQY
Dah Sing Trading Co.
Ophthalmic · 47d