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
3649–3672 of 5,110
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Aug 07, 1989
NIDEK MODEL AKC-8000
K894273 · HQF
Nidek, Inc.
Ophthalmic · 46d
Cleared Aug 03, 1989
JAMES SURGICAL SYSTEM J1000
K890195 · HQE
O.R. Specialties, Inc.
Ophthalmic · 197d
Cleared Aug 02, 1989
CANDELA UPC LASER PHOTOCOAGULATOR
K893630 · HQF
Candela Laser Corp.
Ophthalmic · 83d
Cleared Jul 25, 1989
NEW WEST SUNGLASSES
K893986 · HQY
New West Promotions
Ophthalmic · 50d
Cleared Jun 23, 1989
DELUXE CONTACT LENS HOLDER (HARD & SOFT) #283
K882384 · LRX
Magnivision, Inc.
Ophthalmic · 379d
Cleared Jun 23, 1989
COI 72 HR COLLAGEN SHIELD
K885015 · MOE
Chiron Ophthalmics
Ophthalmic · 200d
Cleared Jun 23, 1989
ITEM #352/#CS352* CONTACT LENS CASES
K890533 · LRX
Magnivision, Inc.
Ophthalmic · 141d
Cleared Jun 23, 1989
GRIESHABER SOFT TIP NEEDLE (20 & 19 GAUGES)
K890782 · HMX
Grieshaber & Co.
Ophthalmic · 128d
Cleared Jun 23, 1989
SPIN-CLEAN CLEANING UNIT
K892372 · LYL
Willmar Contact Lens Co.
Ophthalmic · 78d
Cleared Jun 22, 1989
NIDEK INC. MODELS YC-2000 & 3000 OPHTHALMIC LASERS
K892204 · LXS
Nidek, Inc.
Ophthalmic · 80d
Cleared Jun 16, 1989
PHACO-INJECTOR(TM) INTRAOCULAR LENS IMPLANT INSTR
K893199 · HNR
Allergan Medical Optics
Ophthalmic · 51d
Cleared Jun 15, 1989
ISL QC 2000
K892058 · LXS
Intelligent Surgical Lasers, Inc.
Ophthalmic · 78d
Cleared Jun 15, 1989
COHERENT MARIE ARGON PHOTOCOAGULATOR
K893709 · HQF
Coherent Medical Group
Ophthalmic · 28d
Cleared Jun 08, 1989
SITE PHACO PLUS INFUSION SLEEVE
K892852 · HQC
Site Microsurgical Systems, Inc.
Ophthalmic · 51d
Cleared Jun 05, 1989
HENSON CFA 3000 CENTRAL VISUAL FIELD SCREENER
K891610 · HOD
Keeler Instruments, Inc.
Ophthalmic · 77d
Cleared Jun 05, 1989
VISTA FINOFF TRANSILLUMINATOR (AC-POWERED)
K893170 · HJM
Keeler Instruments, Inc.
Ophthalmic · 41d
Cleared Jun 05, 1989
VISTA OPHTHALMOSCOPE (BATTERY AND AC-POWERED)
K893172 · HLI
Keeler Instruments, Inc.
Ophthalmic · 41d
Cleared Jun 05, 1989
VISTA SPECIALIST OPHTHALMOSCOPE (BATTERY & AC)
K893173 · HLI
Keeler Instruments, Inc.
Ophthalmic · 41d
Cleared May 26, 1989
JUMPER PACK #203
K890825 · HQC
O.R. Specialties, Inc.
Ophthalmic · 98d
Cleared May 26, 1989
VITRECTOMY PACK #J120
K891161 · HQC
O.R. Specialties, Inc.
Ophthalmic · 81d
Cleared May 26, 1989
MAGNILINK SYSTEM 101
K892347 · HJG
Coburn Optical Ind., Inc.
Ophthalmic · 51d
Cleared May 26, 1989
MAGNILINK SYSTEM 201
K892348 · HJG
Coburn Optical Ind., Inc.
Ophthalmic · 51d
Cleared May 26, 1989
MAGNILINK SYSTEM 209
K892349 · HJG
Coburn Optical Ind., Inc.
Ophthalmic · 51d
Cleared May 26, 1989
MAGNILINK SYSTEM 402/5
K892350 · HJG
Coburn Optical Ind., Inc.
Ophthalmic · 51d