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
4993–5016 of 5,110
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Feb 12, 1979
CYSTOTOMES
K790244 · HNY
Visitec Co.
Ophthalmic · 45d
Cleared Feb 09, 1979
SURGICAL EYE SHIELD
K781960 · HJK
Concept, Inc.
Ophthalmic · 80d
Cleared Feb 08, 1979
LASER COAGULATOR, MODEL 41AK
K781965 · HQF
Lasertek OY
Ophthalmic · 76d
Cleared Feb 08, 1979
COAGULATOR, MODEL 40 AARGON
K782106 · HQF
Lasertek OY
Ophthalmic · 57d
Cleared Jan 26, 1979
VISION-STIMULATOR, CAM
K781313 · HPL
Clement Clarke, Inc.
Ophthalmic · 179d
Cleared Jan 26, 1979
INSTRUMENTS, OVERREFRACTION SYSTEM
K782096 · HLM
Zeiss Humphrey System
Ophthalmic · 39d
Cleared Jan 26, 1979
FUL-VUE
K782118 · HKN
American Optical Corp.
Ophthalmic · 30d
Cleared Jan 26, 1979
LEVIGATOR, KEELER PHOKO
K782141 · HQC
Keeler Optical Products , Ltd.
Ophthalmic · 30d
Cleared Dec 28, 1978
LASER, PHOTOCOAGULATION
K782065 · HQF
Cavitron Corp.
Ophthalmic · 15d
Cleared Dec 20, 1978
HUMAN II LENS
K781927 · HQG
Spectra-Shield, Inc.
Ophthalmic · 34d
Cleared Dec 04, 1978
RULER, WECK SCOTT
K781715 · HOE
Edward Weck, Inc.
Ophthalmic · 60d
Cleared Dec 04, 1978
LOCATOR, FOREIGN BODY
K781892 · HPM
Keeler Optical Products , Ltd.
Ophthalmic · 26d
Cleared Nov 15, 1978
MULAR GOLD LEAF ELECTRODE MODEL 7501
K781476 · HLZ
Life-Tech Instruments, Inc.
Ophthalmic · 79d
Cleared Nov 15, 1978
RETINOMETER
K781507 · HPJ
Coburn Optical Ind., Inc.
Ophthalmic · 75d
Cleared Nov 08, 1978
PNEUMATIC VITRECTOMY CONTROL UNIT
K781471 · HQE
Helfgott Medical Instruments
Ophthalmic · 72d
Cleared Nov 03, 1978
CLINITEX VIS-X ASPIRATING ACCESSORY
K780852 · HKP
Varian Assoc., Inc.
Ophthalmic · 165d
Cleared Nov 03, 1978
MAXI-CHAIR
K781801 · HME
Surgical Mechanical Research, Inc.
Ophthalmic · 11d
Cleared Oct 24, 1978
BAYLOW VISUAL ACUITY TESTER
K781452 · HOX
Codman & Shurtleff, Inc.
Ophthalmic · 62d
Cleared Oct 24, 1978
MONOJECT SCALE MAGNIFIER
K781459 · HJY
Sherwood Medical Industries
Ophthalmic · 62d
Cleared Oct 24, 1978
ORBIOGRAPH
K781543 · HLT
Sonometrics Systems, Inc.
Ophthalmic · 46d
Cleared Oct 17, 1978
TERRY KERATOMETER
K781650 · HJA
Clifford M. Terry, M.C.
Ophthalmic · 20d
Cleared Oct 17, 1978
PROJECTOR, ACCU-CHART ACUITY
K781658 · HOS
Bausch & Lomb, Inc.
Ophthalmic · 19d
Cleared Oct 11, 1978
OSCILLATING KNIFE AND ACCESSORIES
K781412 · HMY
Codman & Shurtleff, Inc.
Ophthalmic · 57d
Cleared Sep 28, 1978
SOFT SILICONE ELASTOMER SPONGE EXPLANT
K780987 · HOZ
Medical Instrument Research Assoc., Inc.
Ophthalmic · 106d