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
4153–4176 of 5,110
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Jun 19, 1986
ENTRAVISION EP-500 I/A ECCO PACK
K862064 · HQC
Entravision, Inc.
Ophthalmic · 20d
Cleared Jun 19, 1986
LENS-EZE
K862094 · HJK
Insight International, Inc.
Ophthalmic · 17d
Cleared Jun 17, 1986
GOTTEX SUNGLASSES
K861021 · HQG
Private Eyes Sunglass Corp.
Ophthalmic · 91d
Cleared Jun 17, 1986
CHILDREN'S SUNGLASSES
K861927 · HQY
Jestroy, Ltd.
Ophthalmic · 29d
Cleared Jun 17, 1986
SOFT LENS FOLDER
K861990 · KYB
Staar Surgical Co.
Ophthalmic · 25d
Cleared Jun 17, 1986
ZEISS 30 SL-L
K862004 · HJO
Carl Zeiss, Inc.
Ophthalmic · 21d
Cleared Jun 17, 1986
INTER-SHARP
K862070 · HNW
Intermedics Intraocular, Inc.
Ophthalmic · 18d
Cleared Jun 09, 1986
LENS SPECTACLE NON-CUSTOM (PRESCRIPTION)
K861162 · HQG
Efop
Ophthalmic · 73d
Cleared Jun 09, 1986
SEIKO P-2 & SEIKO P-3 (SPECTACLE LENS)
K861684 · HQG
Seiko Optical Products of America, Inc.
Ophthalmic · 38d
Cleared Jun 09, 1986
SAPPHIRE KNIFE BLADE
K861744 · HNN
Keeler Instruments, Inc.
Ophthalmic · 34d
Cleared Jun 09, 1986
GIRARD SUNGLASSES (NON-PRESCRIPTION)
K861759 · HQG
H. Girard S.A.
Ophthalmic · 34d
Cleared Jun 09, 1986
CORNEAL TRANSPLANT TREPHINE DISPOSABLE BLADE
K861825 · HRH
Storz Instrument Co.
Ophthalmic · 28d
Cleared Jun 09, 1986
ZIMLITE LENS
K861960 · HQG
Asahi Optical Co. C/O Rosati...
Ophthalmic · 20d
Cleared Jun 02, 1986
KANSAS I/A SYSTEM & KANSAS I/A & VITRECTROMY SYST.
K860956 · HQC
Medical Corp. of America
Ophthalmic · 81d
Cleared Jun 02, 1986
DISPOSABLE ACCESSORIES FOR I/A SYS. & VITEOUS CUT.
K860957 · HQC
Medical Corp. of America
Ophthalmic · 81d
Cleared Jun 02, 1986
STYLEKEEPER CONTACT LENS CARRYING CASE
K861643 · HPX
Allergan, Inc.
Ophthalmic · 33d
Cleared Jun 02, 1986
RUBY & SAPPHIRE BLADE HOLDER
K861748 · HNN
Keeler Instruments, Inc.
Ophthalmic · 27d
Cleared May 29, 1986
EASY EYES TM LENS CARRYING CASE
K860677 · HPX
Applied Laboratories, Inc.
Ophthalmic · 93d
Cleared May 29, 1986
LENSKEEPER CONTACT LENS CARRYING CASE
K861642 · HPX
Allergan, Inc.
Ophthalmic · 29d
Cleared May 29, 1986
WETTING & SOAKING HARD CONTACT LENS SOLUTION
K861712 · HPX
Maurry Biological Co.
Ophthalmic · 24d
Cleared May 28, 1986
ELASTIC LENS INJECTOR TM
K861085 · KYB
Staar Surgical Co.
Ophthalmic · 68d
Cleared May 28, 1986
ROPHAE DIAMOND KNIFE
K861491 · HNN
Rophae Lens Co., Inc.
Ophthalmic · 36d
Cleared May 28, 1986
IRRIGATION/ASPIRATION CANNULAS, VARIOUS SIZES
K861545 · HMX
Rophae Lens Co., Inc.
Ophthalmic · 34d
Cleared May 28, 1986
STORZ E9050 & E9055 DIAMOND KNIVES
K861732 · HNN
Storz Instrument Co.
Ophthalmic · 22d