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
4585–4608 of 5,110
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Apr 05, 1984
IOCARE IRRIGATION & ASPIRATION PACK
K834340 · HQC
Chiron Vision Corp.
Ophthalmic · 115d
Cleared Apr 05, 1984
LASER LENS-VARIOUS MODELS
K834610 · HQF
Meditec of America
Ophthalmic · 106d
Cleared Apr 05, 1984
CYSTOTOME, 140-S
K840475 · HNY
Cilco, Inc.
Ophthalmic · 62d
Cleared Apr 02, 1984
MULTIPLE
K833259 · HQG
Sun House Products Co.
Ophthalmic · 195d
Cleared Apr 02, 1984
MEDICAL LASER ENDOCOAGULATOR 5K
K840854 · HQF
Hgm, Inc.
Ophthalmic · 38d
Cleared Mar 30, 1984
KEATES IRRIGATION/ASPIRATION/VITREOUS
K834437 · HQE
Frigitronics of Connecticut, Inc.
Ophthalmic · 102d
Cleared Mar 29, 1984
DOUBLE & SINGLE TANTALUM CLIPS
K840207 · HQW
Storz Instrument Co.
Ophthalmic · 70d
Cleared Mar 29, 1984
IRRIGATION, ASPIRATION TUBING SETS
K841072 · HQC
Innovative Surgical Products, Inc.
Ophthalmic · 17d
Cleared Mar 27, 1984
IMAGE DEFLECTOR
K833669 · HPA
Michael Onufryk
Ophthalmic · 161d
Cleared Mar 22, 1984
WEE BAG O'MERCURY
K840004 · LCC
Surgi-Quip Inc.U
Ophthalmic · 78d
Cleared Mar 19, 1984
OPHTEC RUST RING REMOVER
K834354 · HOG
Jedmed Instrument Co.
Ophthalmic · 97d
Cleared Mar 16, 1984
ERGO DIAGNOSTIC CARD
K834145 · HOX
American Ergo Systems
Ophthalmic · 106d
Cleared Mar 16, 1984
PLASTIC OPTICAL LENS M-110
K834261 · HQC
U-Molde Systems, Inc.
Ophthalmic · 99d
Cleared Mar 16, 1984
ARGON/KRYPTON ION LASER PHOTOCOAGULA
K834305 · HQF
Nidek, Inc.
Ophthalmic · 109d
Cleared Mar 16, 1984
MICRO FORCEPS
K834355 · HNR
Jedmed Instrument Co.
Ophthalmic · 94d
Cleared Mar 16, 1984
EYE SPONGE OR SPEAR
K834356 · HOZ
Jedmed Instrument Co.
Ophthalmic · 94d
Cleared Mar 16, 1984
PHACO FRAGMENTOR GT-1
K834453 · HQC
Fibra Sonics, Inc.
Ophthalmic · 88d
Cleared Mar 16, 1984
MICRO VIT FRAGMENTATION SYSTEM
K834537 · HQC
Medical Instrument Development...
Ophthalmic · 98d
Cleared Mar 16, 1984
OCUCARE ULTRASOUND TIP & FREEDOM PACK
K834543 · HQC
Intermedics Intraocular, Inc.
Ophthalmic · 99d
Cleared Mar 16, 1984
SURGICAL KNIFE
K834546 · HNN
Fine-Cut Diamond Instruments
Ophthalmic · 80d
Cleared Mar 16, 1984
EYE SURGERY INSTRUMENT
K840101 · HOB
Truline Instruments, Inc.
Ophthalmic · 66d
Cleared Mar 16, 1984
CATEGORY 6 OPTHALMIC DEVICES
K840310 · HOB
Imm Enterprises , Ltd.
Ophthalmic · 52d
Cleared Mar 16, 1984
STERILIZED DISPOS. CYSTOTOME
K840442 · HMX
Microsurgical Technology, Inc.
Ophthalmic · 44d
Cleared Mar 16, 1984
NEONATE MASK FOR BABIES
K840444 · HOY
Richards Medical Co., Inc.
Ophthalmic · 44d