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
3793–3816 of 5,110
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared May 25, 1988
NIDEK CV-4000
K880929 · HQE
Nidek, Inc.
Ophthalmic · 82d
Cleared May 25, 1988
SPECTACLE, FRAME AND SUNGLASSES
K881278 · HQY
Nouvelle Ligne Paris
Ophthalmic · 61d
Cleared May 25, 1988
PLASTIC FRAME & LENS SUNGLASS
K881419 · HQY
Marketing Innovations Intl., Inc.
Ophthalmic · 51d
Cleared May 25, 1988
SUNGLASSES
K881594 · HQY
Transfers Intl., Inc.
Ophthalmic · 43d
Cleared May 25, 1988
PRISMA TECH 19 GAUGE DISPOSABLE EXTRUSION NEEDLES
K881927 · HQE
Advanced Surgical Products, Inc.
Ophthalmic · 16d
Cleared May 23, 1988
TEAR VOLUME TESTS
K881515 · KYD
Visionex, Inc.
Ophthalmic · 42d
Cleared May 13, 1988
PRISMA DISPOSABLE 19 AND 20 GAUGE SCLERAL PLUGS
K880952 · LXP
Advanced Surgical Products, Inc.
Ophthalmic · 67d
Cleared May 13, 1988
ADVANCED SURGICAL 19 & 20 GAUGE DISP. SCLERAL PLUG
K880953 · LXP
Advanced Surgical Products, Inc.
Ophthalmic · 67d
Cleared May 13, 1988
MENTOR WET-FIELD*II COAGULATOR
K881001 · HQQ
Mentor O & O, Inc.
Ophthalmic · 65d
Cleared May 13, 1988
ADVANCE DIAGNOSTICS DISPOSABLE EYECUP
K881369 · LXQ
Advantage Diagnostics Corp.
Ophthalmic · 42d
Cleared May 13, 1988
MVR/STILETTO BLADE 20GA. - P/N 1900
K881669 · HNN
Advanced Surgical Products, Inc.
Ophthalmic · 25d
Cleared May 03, 1988
ILLUMINATING INFUSION CONTACT LENS FOR EYE SURGERY
K874591 · HPX
Vitreo Dynamics, Co.
Ophthalmic · 176d
Cleared May 03, 1988
OCU-1
K875030 · HMX
Rudolph Beaver, Inc.
Ophthalmic · 148d
Cleared May 03, 1988
CYSTOTOMES/KNIFES
K880345 · HNY
Myocure, Inc.
Ophthalmic · 98d
Cleared May 03, 1988
CANNULAS
K880346 · HMX
Myocure, Inc.
Ophthalmic · 98d
Cleared May 03, 1988
ANESTHESIA/RETROBULBAR NEEDLES
K880347 · HMX
Myocure, Inc.
Ophthalmic · 98d
Cleared May 03, 1988
BLUE PLASTIC EYE SHIELD
K880490 · HOY
Eye Garter Company, Inc.
Ophthalmic · 89d
Cleared May 03, 1988
AUTOMATIC PERIMETER, AP-340
K881219 · HPT
Kowa Optimed, Inc.
Ophthalmic · 42d
Cleared Apr 29, 1988
OPHTHALMIC CANNULA
K881487 · HMX
Surgical Instrument, Inc.
Ophthalmic · 21d
Cleared Apr 19, 1988
MODEL 2001 PHACOEMULSIFIER ASPIRATOR
K880968 · HQE
Mcghan Instrumed Corp.
Ophthalmic · 42d
Cleared Apr 19, 1988
OPHTHALMIC SPECTACLE LENS BLANKS
K881225 · HQG
Beta Optical Co, Inc.
Ophthalmic · 28d
Cleared Apr 13, 1988
PRISMA DISPOSABLE GILLS ANGLED I/A CANNULA
K874968 · HMX
Advanced Surgical Products, Inc.
Ophthalmic · 133d
Cleared Apr 13, 1988
PRISMA DISPOSABLE KRATZ CAPSULE POLISHER
K874969 · HMX
Advanced Surgical Products, Inc.
Ophthalmic · 133d
Cleared Apr 13, 1988
PRISMA DISPOS. TROUTMAN ALPHA-CHYMOTRYPSIN CANNULA
K874970 · HMX
Advanced Surgical Products, Inc.
Ophthalmic · 133d