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
1801–1824 of 5,110
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Jun 29, 1999
W-55 (METHAFILCON A) CLEAR AND VISIBILITY TINTED LENS BLANK AND HORIZON 55...
K992010 · LPL
Westcon Contact Lens Co., Inc.
Ophthalmic · 14d
Cleared Jun 28, 1999
GENTLE TOUCH UV (NETRAFILCON A) SOFT CONTACT LENSES
K991000 · LPL
Wesley Jessen Corp.
Ophthalmic · 96d
Cleared Jun 08, 1999
VISTAKON (LENEFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES, CLEAR AND...
K991163 · LPL
Vistakon, Johnson & Johnson Vision...
Ophthalmic · 62d
Cleared Jun 07, 1999
LEICA AT550
K990869 · HKX
Leica Microsystems, Inc.
Ophthalmic · 83d
Cleared Jun 03, 1999
THERMAL CAUTERY DEVICE, FORCEPS
K990728 · HQP
Starion Instruments
Ophthalmic · 90d
Cleared Jun 03, 1999
COLORSOFT, COLOR ENHANCED TINTED SOFT CONTACT LENS
K990815 · LPL
Colorsoft Laboratories Corp.
Ophthalmic · 84d
Cleared May 18, 1999
LACRIMAL INTUBATION SET, DACRYOCYSTORHINOSTOMY (DCR) SET
K990672 · OKS
Hurricane Medical
Ophthalmic · 77d
Cleared May 17, 1999
BQ/BM INTEGRATED LASER DELIVERY SYSTEM
K990665 · HQF
American Laser Corp.
Ophthalmic · 76d
Cleared May 14, 1999
KERATOME SYSTEM, MODEL K3000
K984537 · HMY
Insight Technologies Instruments, LLC
Ophthalmic · 144d
Cleared May 14, 1999
FRESHLOOK BIFOCAL UV-ABSORBING (PHEMFILCON A) MOLDED SPHERICAL HANDLING TINT...
K991550 · LPL
Wesley Jessen Corp.
Ophthalmic · 10d
Cleared May 11, 1999
CONTINENTAL 45 TORIC SOFT (HYDROPHILIC) CONTACT LENSES FOR DAILY WEAR
K990011 · LPL
Continental Soft Lens, Inc.
Ophthalmic · 127d
Cleared May 10, 1999
ADVENTURE TINTS, COLOR ENHANCED TINTED SOFT CONTACT LENS
K984098 · LPL
Adventures IN Color Technology, Ltd.
Ophthalmic · 174d
Cleared May 10, 1999
OPTI-FREE SUPRACLENS DAILY PROTEIN REMOVER
K990480 · LPN
Alcon Laboratories
Ophthalmic · 83d
Cleared May 10, 1999
DRAINAGE WICK
K990671 · HOZ
Hurricane Medical
Ophthalmic · 69d
Cleared May 06, 1999
ACUVUE (ETAFILCON A)SOFT (HYDROPHILIC) CONTACT LENSES, CLEAR AND VISIBILITY...
K991134 · LPL
Vistakon, Johnson & Johnson Vision...
Ophthalmic · 34d
Cleared Apr 28, 1999
KERAVISION VACUUM RING SYSTEM
K984540 · HNO
Keravision, Inc.
Ophthalmic · 128d
Cleared Apr 27, 1999
RENU MULTIPLUS MULTI-PURPOSE SOLUTION
K990422 · LPN
Bausch & Lomb, Inc.
Ophthalmic · 75d
Cleared Apr 21, 1999
PVS BASICS
K984436 · HQD
Paragon Vision Sciences
Ophthalmic · 128d
Cleared Apr 21, 1999
CANTOR & SILVER 5X TINTED (HIOXIFILCON A) SOFT (SPHERICAL & TORIC) DAILY WEAR...
K990757 · LPL
Cantor & Silver , Ltd.
Ophthalmic · 44d
Cleared Apr 20, 1999
FLEXPLUG
K991130 · LZU
Eagle Vision, Inc.
Ophthalmic · 18d
Cleared Apr 16, 1999
S-38 (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS, THE ESSTECH PS & SV...
K990281 · LPL
Nissel , Ltd.
Ophthalmic · 78d
Cleared Apr 14, 1999
OXYCON LENS
K990895 · HQD
Concise Contact Lens Co.
Ophthalmic · 28d
Cleared Apr 12, 1999
LABTICIAN LID LOAD EXTERNAL EYELID SIZING SET
K990224 · MML
Labtician Ophthalmics, Inc.
Ophthalmic · 77d
Cleared Apr 04, 1999
DI-RHEX OPHTHALMIC DIATHERMY SYSTEM
K990064 · HQR
Ophthalmic Technologies, Inc.
Ophthalmic · 86d