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
1105–1128 of 5,110
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Sep 05, 2008
RAYNER SINGLE USE SMALL INCISION DISPOSABLE INJECTOR, MODEL R-INJ-06
K081455 · MSS
Rayner Surgical, Inc.
Ophthalmic · 105d
Cleared Aug 28, 2008
BAUSCH & LOMB D4600A AIR EXCHANGE LINE PACK
K082132 · HQC
Bausch & Lomb, Inc.
Ophthalmic · 30d
Cleared Aug 07, 2008
OCULAR RESPONSE ANALYZER
K081756 · HKX
Reichert, Inc.
Ophthalmic · 48d
Cleared Aug 01, 2008
CARRIAZO-PENDULAR MICROKERATOME
K082043 · HNO
Schwind Eye-Tech-Solutions GmbH & Co. KG
Ophthalmic · 14d
Cleared Jul 31, 2008
APPASAMY SLIT LAMP, A1A-11 AND A1A-12 SERIES
K082031 · HJO
Appasamy Associates
Ophthalmic · 14d
Cleared Jul 23, 2008
REVITALEYES, POST-SURGICAL SOFT DAILY WEAR CONTACT LENS (HIOXIFILCON B) CLEAR...
K080512 · LPL
Metro Optics of Austin, Inc.
Ophthalmic · 149d
Cleared Jul 18, 2008
ISCIENCE INTERVENTIONAL OPHTHALMIC MICROCATHETER
K080067 · MPA
Iscience Interventional
Ophthalmic · 190d
Cleared Jul 03, 2008
INTELLIWAVE, SOFT DAILY WEAR CONTACT LENS (ACOFILCON B) HIOXIFILCON B) CLEAR...
K073621 · LPL
Art Optical Contact Lens, Inc.
Ophthalmic · 190d
Cleared Jul 02, 2008
INTEGRE PRO, MODEL L2RY
K081565 · HQF
Ellex Medical Pty, Ltd.
Ophthalmic · 28d
Cleared Jun 24, 2008
CEEMAX SLIT LAMP (HALOGEN LAMP SERIES/SOLID STATE ILLUMINATION SERIES)
K072861 · HJO
Acheve Technology, Inc.
Ophthalmic · 263d
Cleared Jun 20, 2008
DUCKWORTH & KENT LTD INJECTOR, MODEL: DK7797-2
K072985 · KYB
Duckworth & Kent, Ltd.
Ophthalmic · 241d
Cleared Jun 11, 2008
MODIFICATION TO RETINAL FUNCTION IMAGER (RFI)
K080180 · HKI
Optical Imaging , Ltd.
Ophthalmic · 139d
Cleared Jun 10, 2008
SOFLENS DAILY DISPOSABLE TORIC (HILAFILCON B) VISIBILITY TINTED CONTACT LENS
K080755 · MVN
Bausch & Lomb, Inc.
Ophthalmic · 85d
Cleared Jun 03, 2008
FALCK APPLANATION TONOMETER (FAT2)
K071755 · HKY
Falck Medical, Inc.
Ophthalmic · 341d
Cleared May 30, 2008
SYNERGEYES HYBRID CONTACT LENSES - DAILY WEAR, MODELS A, M, KC AND PS
K081034 · HQD
Synergeyes, Inc.
Ophthalmic · 49d
Cleared May 09, 2008
ALCON VISION SYSTEM
K063583 · HQC
Alcon
Ophthalmic · 526d
Cleared May 06, 2008
OPHTHALMOSCOPE F-10
K072259 · MYC
Nidek Co., Ltd.
Ophthalmic · 266d
Cleared Apr 24, 2008
CR-1
K080883 · HKI
Canon, Inc.
Ophthalmic · 24d
Cleared Apr 22, 2008
WESTCON HORIZON 49% (HIOXIFILCON B)
K080686 · LPL
Westcon Contact Lens Co.
Ophthalmic · 42d
Cleared Apr 04, 2008
KOWA GENESIS-D
K080681 · HKI
Kowa Co. , Ltd.
Ophthalmic · 25d
Cleared Mar 19, 2008
DURETTE IMPLANT
K073293 · HPZ
Oculo Plastik, Inc.
Ophthalmic · 117d
Cleared Mar 13, 2008
MICROSTAAR INDIGO INJECTOR FOAM TIP SYSTEM
K073586 · MSS
Staar Surgical Co.
Ophthalmic · 84d
Cleared Mar 13, 2008
MICROSTAAR MSI INJECTOR FOAM TIP SYSTEM
K073591 · MSS
Staar Surgical Co.
Ophthalmic · 84d
Cleared Mar 12, 2008
STERILS SINGLE-USE I/A HANDPIECES
K073023 · HQC
Bausch & Lomb, Inc.
Ophthalmic · 138d