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
2737–2760 of 5,110
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Jul 25, 1994
SUNGLASSES, SPECTACLE FRAMES
K940372 · HQY
Giorgio Nannini Srl
Ophthalmic · 180d
Cleared Jul 25, 1994
SUNGLASSES
K940925 · HQY
Gold Link Design , Ltd.
Ophthalmic · 147d
Cleared Jul 25, 1994
HAPPY EYES OPTICAL CO. SUNGLASSES
K941581 · HQY
Happy Eye Optical Co.
Ophthalmic · 116d
Cleared Jul 25, 1994
SUNGLASSES
K941874 · HQY
The Fair Optical Ent.Co. , Ltd.
Ophthalmic · 98d
Cleared Jul 25, 1994
SUNGLASSES
K942001 · HQY
Hung Wai Optical Co.
Ophthalmic · 91d
Cleared Jul 25, 1994
SUNGLASSES
K942037 · HQY
Golden Year Supply Co.
Ophthalmic · 88d
Cleared Jul 25, 1994
SUNGLASSES
K942038 · HQY
Golden Year Supply Co.
Ophthalmic · 88d
Cleared Jul 25, 1994
SAM SUNG OPTICAL
K942067 · HQY
Sam Sung Optical
Ophthalmic · 87d
Cleared Jul 25, 1994
PHACO KIT
K942515 · HQC
Surgin Surgical Instrumentation, Inc.
Ophthalmic · 60d
Cleared Jul 25, 1994
10-0 CASSETTE
K942516 · HQC
Surgin Surgical Instrumentation, Inc.
Ophthalmic · 60d
Cleared Jul 25, 1994
10-K CASSETTE
K942517 · HQC
Surgin Surgical Instrumentation, Inc.
Ophthalmic · 60d
Cleared Jul 25, 1994
CASSETTE SYSTEM FOR SITE
K942518 · HQC
Surgin Surgical Instrumentation, Inc.
Ophthalmic · 60d
Cleared Jul 25, 1994
NON-PRESCRIPTION SUNGLASSES
K942673 · HQY
Angel Eyewear
Ophthalmic · 49d
Cleared Jul 25, 1994
SPECTACLE FRAMES
K942750 · HQZ
Aspex Eyewear, Inc.
Ophthalmic · 45d
Cleared Jul 25, 1994
NIL
K942755 · HQY
Ever Great International , Ltd.
Ophthalmic · 45d
Cleared Jul 25, 1994
ORVIS WORLD FINEST POLARIZED CLIP ONS
K942952 · HQY
The Orvis Co., Inc.
Ophthalmic · 32d
Cleared Jul 25, 1994
SPECTACLE FRAME
K943084 · HQZ
Samil Enterprise Co.
Ophthalmic · 27d
Cleared Jul 19, 1994
MICRON-SCOPE II
K926412 · HMS
Chiron Vision Corp.
Ophthalmic · 575d
Cleared Jul 18, 1994
OPHTHALMIC CRYO UNIT
K940373 · HPS
Dutch Ophthalmic USA, Inc.
Ophthalmic · 173d
Cleared Jul 18, 1994
NERVE FIBER ANALYZER
K941705 · HLI
Carl Zeiss Meditec, Inc.
Ophthalmic · 103d
Cleared Jul 15, 1994
NON-PRESCRIPTION SUNGLASSES
K936072 · HQY
King'S Sunglass Corp.
Ophthalmic · 207d
Cleared Jul 15, 1994
NIDEK MODEL VT-4000, MODIFICATION
K936302 · HQE
Nidek, Inc.
Ophthalmic · 198d
Cleared Jul 15, 1994
RETURN PATH DIATHERMY HANDLE
K941495 · HQR
Mira, Inc.
Ophthalmic · 109d
Cleared Jul 15, 1994
U-TOP ENTERPRISE CO SPECTACLE FRAMES & SUNGLASSES
K942119 · HQY
U-Top Enterprise Co., Ltd.
Ophthalmic · 73d