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
3745–3768 of 5,110
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Sep 15, 1988
MODIFICATION TO THE SITE PERISTALTIC MODULE SYSTEM
K883199 · HQC
Chiron Vision Corp.
Ophthalmic · 49d
Cleared Sep 15, 1988
NIDEK OPEATING MICROSCOPE DELIVERY SYSTEM (OMDS)
K883213 · HQF
Nidek, Inc.
Ophthalmic · 48d
Cleared Sep 15, 1988
SUNGLASSES, IMPORTED
K883771 · HQY
Norcon, Inc.
Ophthalmic · 9d
Cleared Sep 12, 1988
BRADBURY INTRAOCULAR RETINAL KIT CAT #200
K881049 · HNR
Microline Pentax, Inc.
Ophthalmic · 185d
Cleared Sep 12, 1988
COLLAGEN SHIELD
K882762 · MOE
Chiron Ophthalmics
Ophthalmic · 68d
Cleared Sep 12, 1988
MODIFIED SITE MOBILE STAND FOR OPHTHALMIC USE
K883575 · HMG
Site Microsurgical Systems, Inc.
Ophthalmic · 21d
Cleared Sep 08, 1988
VAC-G (GUILLOTINE VITRECTOR)
K881519 · HQE
B&B Medical Assoc., Inc.
Ophthalmic · 150d
Cleared Sep 07, 1988
VAC (OSCILLATING VITRECTOR)
K881520 · HQE
B&B Medical Assoc., Inc.
Ophthalmic · 149d
Cleared Sep 06, 1988
EOL, MODEL LIO
K881984 · HLI
Eol, Inc.
Ophthalmic · 117d
Cleared Aug 30, 1988
FOUR MODIFICATIONS TO OPHTHALAS ARGON/DYE LASER
K881494 · HQF
Biophysic Medical, Inc.
Ophthalmic · 144d
Cleared Aug 25, 1988
MULTIPLE SPECTACLE FRAMES
K883100 · HQZ
Metal Optics U.S.A., Inc.
Ophthalmic · 34d
Cleared Aug 24, 1988
SUNGLASSES, NON-PRESCRIPTION
K882769 · HQY
Spotlight Industries, Inc.
Ophthalmic · 49d
Cleared Aug 24, 1988
OPTICAL OR EYEGLASS FRAME
K883226 · HQZ
Unique Optic , Ltd.
Ophthalmic · 23d
Cleared Aug 24, 1988
MODIFIED SITE FIBER OPTIC MODULE FOR OPHTHAL. USE
K883480 · FCT
Site Microsurgical Systems, Inc.
Ophthalmic · 8d
Cleared Aug 22, 1988
SUNGLASSES
K872786 · HQY
Quality Sunglasses, Ltd.
Ophthalmic · 405d
Cleared Aug 22, 1988
B & B I/A HANDPIECE
K881517 · KYG
B&B Medical Assoc., Inc.
Ophthalmic · 133d
Cleared Aug 22, 1988
INFUSION HANDLE
K881518 · KYG
B&B Medical Assoc., Inc.
Ophthalmic · 133d
Cleared Aug 22, 1988
RETRACTIVE INCISION MICROMETER (RIM) GUAGE
K882402 · HNN
Optical Center
Ophthalmic · 73d
Cleared Aug 22, 1988
IOL IMPLANTATION FORCEPS
K883197 · HNR
D & D Surgical
Ophthalmic · 25d
Cleared Aug 22, 1988
EV MONOCANALICULAR STENT (TM)
K883233 · OKS
Eagle Vision, Inc.
Ophthalmic · 21d
Cleared Aug 18, 1988
CANON AUTOREFRACTOMETER R-22
K883200 · HKO
Canon USA, Inc.
Ophthalmic · 21d
Cleared Aug 08, 1988
CLEAR EYE GARTER SHIELD
K880489 · HOY
Eye Garter Company, Inc.
Ophthalmic · 186d
Cleared Aug 04, 1988
OCU-FILM TIP COVER
K882750 · HKY
Oculab, Inc.
Ophthalmic · 30d
Cleared Aug 04, 1988
STORZ INFUSION CANNULA
K882884 · HMX
Storz Instrument Co.
Ophthalmic · 24d