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
2449–2472 of 5,110
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared May 10, 1995
VACUUM SURGE SUPRESSER
K950600 · HQC
Surgin Surgical Instrumentation, Inc.
Ophthalmic · 90d
Cleared May 10, 1995
SUNGLASSES, NONPRESCRIPTION
K951131 · HQY
Gold, Inc.
Ophthalmic · 58d
Cleared May 10, 1995
BENSON AND ASHLEY
K951438 · HQY
Benson & Ashley, Inc.
Ophthalmic · 44d
Cleared May 09, 1995
FMS ARTHRO-CUTTER
K951701 · HNX
Future Medical Systems, Inc.
Ophthalmic · 27d
Cleared May 08, 1995
SCHIOTZ TONOMETER SPEC. 5 STRAIGHT, INCLINED, 3INCLINED SCALE
K945541 · HKY
Rudolf Riester GmbH & Co. KG
Ophthalmic · 179d
Cleared May 05, 1995
THE GRIESHABER AXIAL CUTTER
K950056 · HKP
Grieshaber & Co.
Ophthalmic · 119d
Cleared May 02, 1995
BURR, CORNEAL, BATTERY-POWERED
K950520 · HOG
Aaron Medical Industries
Ophthalmic · 85d
Cleared May 02, 1995
POWER RANGERS SUNGLASSES
K951008 · HQY
Siegel,Mandell & Davidson,P.C.
Ophthalmic · 57d
Cleared Apr 28, 1995
NONE-GENERIC
K940724 · HQY
Top Fashion Optical & Sunglasses
Ophthalmic · 434d
Cleared Apr 28, 1995
PRO-VIT
K950799 · HQE
M. Imonti and Associates Inc.,
Ophthalmic · 66d
Cleared Apr 28, 1995
SUNNEX FASHION CORP. NON-PRESCRIPTION SUNGLASSES
K951504 · HQY
Sunnex Fashion Corp.
Ophthalmic · 25d
Cleared Apr 18, 1995
NONE-GENERIC
K940725 · HQY
Yon'S Jay Enterprise Co.
Ophthalmic · 424d
Cleared Apr 18, 1995
FRINDLEY ENTERPRISE CO
K942142 · HQY
Frindley Enterprise Co., Ltd.
Ophthalmic · 350d
Cleared Apr 18, 1995
INFINITECH ASPIRATING LASER PROBE
K946135 · HQE
Surgical Technologies, Inc.
Ophthalmic · 123d
Cleared Apr 18, 1995
SUNGLASSES
K951439 · HQY
Long Train Enterprise Co., Ltd.
Ophthalmic · 22d
Cleared Apr 13, 1995
ALLURE (METHAFILCON A) SOFT (HYDROPHILIC) DAILY WEAR CONTACT LENS
K942374 · LPL
Sunsoft Corp.
Ophthalmic · 330d
Cleared Apr 11, 1995
OTI MODEL TLS-60
K951437 · HPC
Oti Medical, LLC
Ophthalmic · 15d
Cleared Apr 10, 1995
LOW TEMPERATURE CAUTERY FINE TIP, ADJUSTABLE, REPLACEABLE TIP
K945761 · HQP
Aaron Medical Industries
Ophthalmic · 152d
Cleared Apr 10, 1995
RUNNING SUNGLASSES
K945808 · HQY
Million HU Corp.
Ophthalmic · 133d
Cleared Apr 10, 1995
UNIVIT PROBE
K950287 · HKP
Medical Instrument Development...
Ophthalmic · 76d
Cleared Apr 10, 1995
NEITZ SLIT LAMP SL-H1
K951340 · HJO
Neitz Instruments Company, Ltd.
Ophthalmic · 17d
Cleared Apr 07, 1995
GELFLEX
K940848 · LPL
Venture Management Corp.
Ophthalmic · 408d
Cleared Apr 07, 1995
DELTA
K943178 · LPL
Venture Management Corp.
Ophthalmic · 276d
Cleared Apr 07, 1995
PRO-TEC-CASE
K950530 · LRX
Hyman, Phelps & McNamara, P.C.
Ophthalmic · 59d