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
4177–4200 of 5,110
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared May 14, 1986
CANON AUTO REF KERATOMETER RK-1
K861415
Canon USA, Inc.
Ophthalmic · 29d
Cleared May 14, 1986
CANON AUTO ACUITOMETER CV-10
K861416 · HOX
Canon USA, Inc.
Ophthalmic · 29d
Cleared May 14, 1986
OPTICAL MARKERS/FIXATION RING/CANNU & IRRIGA CANNU
K861535 · HMR
CooperVision, Inc.
Ophthalmic · 20d
Cleared May 06, 1986
SITE DISPOSABLE CASSETTE
K860989 · HQC
Microsurgical Systems, Inc.
Ophthalmic · 50d
Cleared May 06, 1986
KETA HAND-HELD TONOMETER
K861027 · HKS
Keta Corp.
Ophthalmic · 49d
Cleared May 06, 1986
SITE PHACO DISPOSABLE CASSETTE
K861060 · HQC
Site Microsurgical Systems, Inc.
Ophthalmic · 47d
Cleared May 06, 1986
XTAL X-800 SHADOWGRAPH
K861163
Xtal Corp.
Ophthalmic · 39d
Cleared May 02, 1986
CILCO DIAMOND KNIVES & DIAMOND KNIFE LINEAR GAUGE
K861334 · HNN
Cilco, Inc.
Ophthalmic · 23d
Cleared Apr 28, 1986
MULTI-SPIKE
K861203 · KYG
Surgeon Surgical Instrumentation, Inc.
Ophthalmic · 27d
Cleared Apr 28, 1986
ULTRA-VIOLET GOGGLETS
K861333
Health Saver Products
Ophthalmic · 19d
Cleared Apr 24, 1986
BIO-PEN CALCULATOR
K860205 · LQB
Oculab, Inc.
Ophthalmic · 92d
Cleared Apr 24, 1986
MANUAL OPHTHALMIC SURGICAL INSTRUMENTS
K861057 · HNR
Precision-Cosmet Co., Inc.
Ophthalmic · 36d
Cleared Apr 24, 1986
MANUAL OPHTHALMIC SURGICAL INSTRUMENTS
K861141 · HNR
CooperVision, Inc.
Ophthalmic · 29d
Cleared Apr 21, 1986
AM-100 I/A AMPAC
K860770 · HQC
Dravon Medical, Inc.
Ophthalmic · 49d
Cleared Apr 21, 1986
WRAPPERS, SUNGLASSES
K860794 · HQG
Mhci Corp.
Ophthalmic · 48d
Cleared Apr 21, 1986
AIVUS (7000), ASPIRATION AND IRRIGATION DEVICE
K860891 · HQE
Intra-Optics Labs. C/O Newman Assoc.
Ophthalmic · 42d
Cleared Apr 15, 1986
PHOTRON VISUAL FIELD ANALYZER
K860642 · HOM
Biosan Laboratories, Inc.
Ophthalmic · 54d
Cleared Apr 15, 1986
STORZ/MAZZACCO LENS FORCEP
K860915 · HNR
Storz Instrument Co.
Ophthalmic · 35d
Cleared Apr 15, 1986
LM-850 AUTOMATIC LENSMETER
K861064 · HLM
Nidek, Inc.
Ophthalmic · 26d
Cleared Apr 09, 1986
AR-1100 AUTOMATIC REFRACTOR
K861065 · HKO
Nidek, Inc.
Ophthalmic · 20d
Cleared Apr 04, 1986
BAUSCH & LOMB LENS CARRYING CASE
K854968 · HPX
Bausch & Lomb, Inc.
Ophthalmic · 114d
Cleared Apr 04, 1986
GUNKEL CHROMAGRAPH COLOR VISION TESTER
K860174 · HIW
Chromagraphics, Inc.
Ophthalmic · 77d
Cleared Apr 04, 1986
BACSTOP FILTER IRRIGATION SUPPLY KIT
K860544 · KYG
Staar Surgical Co.
Ophthalmic · 50d
Cleared Apr 04, 1986
EYEMETER
K860928
Indivisual Corporation, Inc.
Ophthalmic · 24d