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
4609–4632 of 5,110
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Mar 16, 1984
EYE SPEAR
K840471 · HOZ
Surgicot, Inc.
Ophthalmic · 42d
Cleared Mar 16, 1984
ANTERIOR CAPSULECTOMY CYSTITOME
K840659 · HNY
Sharpoint, Inc.
Ophthalmic · 30d
Cleared Mar 16, 1984
POSTERIOR CAPSULOTOMY CYSTITOME
K840660 · HNY
Sharpoint, Inc.
Ophthalmic · 30d
Cleared Mar 15, 1984
DISPOSABLE FIBER OPTIC ILLUMINATOR
K833465 · HQC
CooperVision, Inc.
Ophthalmic · 162d
Cleared Mar 12, 1984
DOWNING SPECTRAL ILLUMINATOR
K833446 · HLX
Vision Health Technology
Ophthalmic · 159d
Cleared Mar 12, 1984
I/A PLUS PAK SURGICAL SYSTEM
K833961 · HQC
Ipax, Inc.
Ophthalmic · 117d
Cleared Mar 12, 1984
KPE PLUS-PAK SURGICAL SYSTEM
K833962 · HQC
Ipax, Inc.
Ophthalmic · 117d
Cleared Mar 06, 1984
LASER MIRROR
K840982
American V. Mueller
Ophthalmic
Cleared Mar 05, 1984
DOWING OPHTHALMIC CHAIR-NON/AC POWER
K833538 · HMD
Vision Health Technology
Ophthalmic · 152d
Cleared Mar 05, 1984
DOWING OPHTHALMIC CHAIR AC-POWERED
K833539 · HME
Vision Health Technology
Ophthalmic · 152d
Cleared Mar 05, 1984
PHAKO SYSTEMS VIA 2000
K833642 · HQC
Pharosystems, Inc.
Ophthalmic · 140d
Cleared Mar 05, 1984
DISPOS. I/A & IRRIGATION HANDPIECES
K833783 · HQC
CooperVision, Inc.
Ophthalmic · 129d
Cleared Mar 05, 1984
JAKOBI SURG. INSTRUMENTS #6 50
K834187 · HKY
Imm Enterprises , Ltd.
Ophthalmic · 105d
Cleared Mar 02, 1984
TEXAS BIO SCAN
K833694 · HKI
Texas Bio Scan
Ophthalmic · 136d
Cleared Feb 21, 1984
OMYL -ARDE- SPECTACLE FRAME
K833401 · HQZ
I.J. Langleb , Ltd.
Ophthalmic · 144d
Cleared Feb 21, 1984
DISPOSABLE I/A HANDPIECE
K833784 · HQC
CooperVision, Inc.
Ophthalmic · 116d
Cleared Feb 10, 1984
OCUMAP 100 AUTOPERIMETER
K832555 · HPT
Shorashim
Ophthalmic · 193d
Cleared Feb 08, 1984
CROUCH CORNEAL PROTECTOR
K833256 · HOY
Star Instrument Co.
Ophthalmic · 141d
Cleared Feb 04, 1984
OCULASE 514 OPHTHALMIC ARGON LASER
K833532 · HQF
Lasermed Corp.
Ophthalmic · 116d
Cleared Feb 04, 1984
RELIANCE OPHTHALMIC SLIT LAMP R-083
K834060 · HQF
F. & F. Koenigkramer
Ophthalmic · 71d
Cleared Jan 30, 1984
MODEL 150K LASER COAGULATOR
K832089 · HQF
Lasertek OY
Ophthalmic · 221d
Cleared Jan 30, 1984
OPHTHALMIC ARGON LASER #700A
K832316 · HQF
Laser Industries , Ltd.
Ophthalmic · 199d
Cleared Jan 30, 1984
ARGON LASER SYS-MODEL 5000
K832703 · HQE
Cooper Medical Corp.
Ophthalmic · 172d
Cleared Jan 30, 1984
LASER PHOTOCOAGULATOR 1520-A & K
K833533 · HQF
Britt Corp., Inc.
Ophthalmic · 111d