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
1345–1368 of 5,110
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Jun 18, 2004
M3 MICROKERATOME
K032836 · HNO
Moria SA
Ophthalmic · 281d
Cleared Jun 17, 2004
MULTIJECT INJECTOR AND MICROGLIDE CARTRIDGE
K040837 · MSS
Medicel AG
Ophthalmic · 78d
Cleared Jun 15, 2004
S-42 UV, T-42 UV TORIC AND M-42 UV MULTIFOCAL (HEFILCON A) SOFT (HYDROPHILIC)...
K040900 · LPL
Optical Connection, Inc.
Ophthalmic · 70d
Cleared Jun 10, 2004
RE-USEABLE MICROSTAAR INJECTOR, MSI-S
K032412 · KYB
Staar Surgical Co.
Ophthalmic · 310d
Cleared Jun 10, 2004
EYE SPHERE IMPLANTS
K040689 · HPZ
Oculo Plastik, Inc.
Ophthalmic · 86d
Cleared May 27, 2004
POLYVIAL/POLYPAK, CONTACT LENS CASE AND STORAGE SYSTEM CONTAINER FOR OPHTHALMICS
K040914 · LRX
Exero Products, Inc.
Ophthalmic · 49d
Cleared May 25, 2004
M2 COMPATIBLE MICROKERATOME BLADE
K033457 · HNO
Micro Specialties, Inc.
Ophthalmic · 208d
Cleared May 24, 2004
RTA MODEL D RETINAL THICKNESS ANALYZER
K041290 · HLI
Talia Technology , Ltd.
Ophthalmic · 11d
Cleared Mar 31, 2004
ONEUSE- PLUS MICROKERATOME
K040297 · HMY
Moria SA
Ophthalmic · 51d
Cleared Mar 26, 2004
PRIZM KERATOME BLADE, MODEL MK8512M2
K033236 · HNO
Surgin Surgical Instrumentation, Inc.
Ophthalmic · 172d
Cleared Mar 22, 2004
ZYOPTIX XP MICROKERATOME
K040204 · HNO
Bausch & Lomb, Inc.
Ophthalmic · 53d
Cleared Mar 19, 2004
OPTIMUM GP (OXYGEN PERMEABLE) DAILY WEAR CONTACT LENSES
K033594 · HQD
Contamac, Ltd.
Ophthalmic · 127d
Cleared Mar 19, 2004
KERATO ANALYZER (EKA)
K040373 · NQE
Konan Medical, Inc.
Ophthalmic · 31d
Cleared Mar 12, 2004
CIBA VISION (LOTRAFILCON B) SPHERICAL, TORIC, MULTIFOCAL AND TORIC MULTIFOCAL...
K033919 · LPL
Ciba Vision Corporation
Ophthalmic · 85d
Cleared Mar 08, 2004
PANORET, MODEL PNM 60
K040325 · HKI
Medibell Medical Vision Technologies...
Ophthalmic · 27d
Cleared Mar 05, 2004
I-LUX INNOVA BLUE TINT LENS, MODEL SUPER O2
K033136 · LPL
Innova Vision, Inc.
Ophthalmic · 157d
Cleared Feb 20, 2004
HORIZON (METHAFILCON A) DAILY WEAR SPHERE AND TORIC CONTACT LENSES
K031774 · LPL
Westcon Contact Lens Co., Inc.
Ophthalmic · 256d
Cleared Feb 20, 2004
DORC VITRECTOMY LENSES, MODEL 1284 SERIES
K033950 · HJK
Dutch Ophthalmic Research Center...
Ophthalmic · 60d
Cleared Feb 10, 2004
MILLENNIUM MICROSURGICAL SYSTEM AND PERISTALTIC PHACO PACK
K033941 · HQF
Bausch & Lomb, Inc.
Ophthalmic · 53d
Cleared Feb 04, 2004
ACUVUE 2 COLOURS BRAND (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS WITH UV...
K033969 · LPL
Vistakon
Ophthalmic · 44d
Cleared Feb 02, 2004
AQUIFY MULTI-PURPOSE SOLUTION
K033608 · LPN
Ciba Vision Corporation
Ophthalmic · 77d
Cleared Feb 02, 2004
SAUFLON FLAT LENS CASE/SAUFLON 2003 BARREL LENS CASE
K033656 · LRX
Sauflon Pharmaceuticals, Ltd.
Ophthalmic · 73d
Cleared Jan 30, 2004
PRIZM KERATOME BLADE (B.D. MODEL), MODEL MK8530BD
K033182 · HNO
Surgin Surgical Instrumentation, Inc.
Ophthalmic · 121d
Cleared Jan 20, 2004
NON-CONTACT TONOMETERS, OCULAR RESPONSE ANALYZER
K032799 · HKX
Reichert, Inc.
Ophthalmic · 133d