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
4561–4584 of 5,110
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared May 09, 1984
OPTHERM FINE TIP
K840425 · HQP
Suncoast Medical Manufacturers, Inc.
Ophthalmic · 99d
Cleared May 09, 1984
OPTHERM EXTRA FINE TIP
K840426 · HQP
Suncoast Medical Manufacturers, Inc.
Ophthalmic · 99d
Cleared May 09, 1984
SUN-LITE BLUE SPOT
K840427
Suncoast Medical Manufacturers, Inc.
Ophthalmic · 99d
Cleared May 09, 1984
SUN-LITE PEN LIGHT
K840428
Suncoast Medical Manufacturers, Inc.
Ophthalmic · 99d
Cleared May 09, 1984
SUN-LITE WHITE SLIT
K840430
Suncoast Medical Manufacturers, Inc.
Ophthalmic · 99d
Cleared May 09, 1984
FLEISCHMAN-SWARTZ ENDO-OCULAR PROBE
K840590 · HQF
Hgm, Inc.
Ophthalmic · 90d
Cleared May 09, 1984
LENS INSERTION GLIDE
K840694 · KYB
Innovative Surgical Products, Inc.
Ophthalmic · 83d
Cleared May 09, 1984
CORNEAL SCLERAL LANCE
K840855 · HNN
Sharpoint, Inc.
Ophthalmic · 75d
Cleared May 09, 1984
TSE-ANDERSON MODIFIED LACRIMAL GROOV
K840861 · HNL
Hansen Ophthalmic Development Lab
Ophthalmic · 75d
Cleared May 09, 1984
SITE COAXIAL I/A HANDPIECE 30 TIP
K840965 · HQC
Chiron Vision Corp.
Ophthalmic · 64d
Cleared May 09, 1984
LACHRYMAL PROBES-VARIOUS
K841002 · HNW
Premier Dental Products Co.
Ophthalmic · 61d
Cleared May 09, 1984
OPHTHALMIC CURETTE-VARIOUS
K841007 · HNZ
Premier Dental Products Co.
Ophthalmic · 61d
Cleared May 09, 1984
SPECTACLE INDIRECT OPHTHALMOSCOPE
K841292 · HLJ
Keller Instruments, Inc.
Ophthalmic · 41d
Cleared May 09, 1984
PANORAMIC LOUPES - VARIOUS
K841293 · HLT
Keller Instruments, Inc.
Ophthalmic · 41d
Cleared May 09, 1984
REPLACE-A-TIP RECHARG. LOW TEMP.
K841325 · HQP
Suncoast Medical Manufacturers, Inc.
Ophthalmic · 37d
Cleared May 09, 1984
REPLACE-A-TIP RECHARGEABLE HIGH TEMP
K841326 · HQP
Suncoast Medical Manufacturers, Inc.
Ophthalmic · 37d
Cleared Apr 26, 1984
OFTALMOGRAF
K833024
Universal Instruments Corp.
Ophthalmic · 233d
Cleared Apr 25, 1984
MONITOR CO2 LASER SURGICAL SYSTEM
K840145 · HQF
Cooper Lasersonics, Inc.
Ophthalmic · 103d
Cleared Apr 24, 1984
PETRUS IOL GUIDE
K840104 · KYB
Precision-Cosmet Co., Inc.
Ophthalmic · 105d
Cleared Apr 23, 1984
ELMED WMC 10 AND BC 50 M/M
K832589
Elmed, Inc.
Ophthalmic · 265d
Cleared Apr 23, 1984
SURG A STAT FINE TIP 5
K840493
Suncoast Medical Manufacturers, Inc.
Ophthalmic · 77d
Cleared Apr 13, 1984
VISTECH VCTS 6000
K840255 · HOX
Vistech Consultants, Inc.
Ophthalmic · 81d
Cleared Apr 13, 1984
SUN-LITE ONE MILLIMETER
K840429
Suncoast Medical Manufacturers, Inc.
Ophthalmic · 73d
Cleared Apr 13, 1984
SUN-LITE 1
K840456
Suncoast Medical Manufacturers, Inc.
Ophthalmic · 71d