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
1921–1944 of 5,110
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared May 01, 1998
KERATOME BLADE, CHIROM MODEL ALK 500500
K980508 · HNO
Micro Specialties, Inc.
Ophthalmic · 80d
Cleared May 01, 1998
KERATOME BLADE (135 MICRON, MODEL 300135), (160 MICRON, MODEL 300160), (200...
K980510 · HNO
Micro Specialties, Inc.
Ophthalmic · 80d
Cleared May 01, 1998
SCMD-1000
K980985 · HNO
Howard Instruments, Inc.
Ophthalmic · 45d
Cleared Apr 30, 1998
PEREGRINE OPTIPORT VITRECTOMY PROBE MODEL PD500.20
K980399 · HQE
Peregrine Surgical , Ltd.
Ophthalmic · 87d
Cleared Apr 30, 1998
PVRS-PEREGRINE VITREORETINAL SCISSOR MODEL PD505.10
K980400 · HQE
Peregrine Surgical , Ltd.
Ophthalmic · 87d
Cleared Apr 30, 1998
SILICONE PUNCTAL PLUG
K980437 · LZU
Oasis Medical, Inc.
Ophthalmic · 85d
Cleared Apr 24, 1998
KONAN NONCON ROBO PACHY SPECULAR MICROSCOPE AND OPTICL PACHYMETER
K980357 · HKI
Konan, Inc.
Ophthalmic · 85d
Cleared Apr 22, 1998
MICROKERATOME OR THE MATE
K974598 · HNO
Howard Instruments, Inc.
Ophthalmic · 134d
Cleared Apr 22, 1998
FREQUENCY UV (ETAFILCON A) HYDROPHILIC CONTACT LENS FOR DAILY WEAR (CLEAR AND...
K980634 · LPL
Aspect Vision Care, Ltd.
Ophthalmic · 62d
Cleared Apr 20, 1998
AHMED GLAUCOMA VALVE, MODEL S3
K980657 · KYF
New World Medical, Inc.
Ophthalmic · 74d
Cleared Apr 16, 1998
PROCLEAR (OMAFILCON A) DAILY WEAR CONTACT LENS
K974408 · LPL
Biocompatibles Eyewear, Inc.
Ophthalmic · 143d
Cleared Apr 15, 1998
PLANCON MICROLAMELLAR KERATOME EVOLUTION
K980924 · HNO
Plancon Instruments
Ophthalmic · 35d
Cleared Apr 13, 1998
YOUR CHOICE MULTI-PURPOSE CONTACT LENS CLEANING SOLUTION
K980147 · LPN
Automatic Liquid Packaging, Inc.
Ophthalmic · 88d
Cleared Apr 08, 1998
AIRPERM (SIFLUFOCON A) RIGID GAS PERMEABLE OK CONTACT LENSES FOR DAILY WEAR...
K973697 · MUW
Airperm, Inc.
Ophthalmic · 194d
Cleared Apr 07, 1998
KEELER TEARSCOPE-PLUS
K973064 · HJO
Keeler Instruments, Inc.
Ophthalmic · 232d
Cleared Apr 07, 1998
ALDEN CLASSIC TINTED (POLYMACON) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT...
K980554 · LPL
Alden Optical Labs., Inc.
Ophthalmic · 53d
Cleared Mar 31, 1998
PEREGRINE TAPERED DIFFUSION PROBE
K980025 · MPA
Peregrine Surgical , Ltd.
Ophthalmic · 85d
Cleared Mar 31, 1998
PEREGRINE SHIELDED DIFFUSION PROBE
K980027 · MPA
Peregrine Surgical , Ltd.
Ophthalmic · 85d
Cleared Mar 30, 1998
FLOSI RIGID GAS PERMEABLE CONTACT LENS
K974636 · HQD
Futuristic Design Assoc.
Ophthalmic · 108d
Cleared Mar 30, 1998
POLYVUE, SILVER CHORD AND UNISOFT (METHAFILCON A) SPHERICAL, ASPHERICAL,...
K980818 · LPL
Stephen A. Dunn, Inc.
Ophthalmic · 27d
Cleared Mar 23, 1998
METHAFILCON A SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR
K980218 · LPL
Biocompatibles Eyewear, Inc.
Ophthalmic · 66d
Cleared Mar 23, 1998
STORZ MILLENNIUM MICROSURGICL SYSTEM HIGH SPEED VITRECTOMY SYSTEM
K980488 · HQE
Storz Instrument Co.
Ophthalmic · 42d
Cleared Mar 13, 1998
PAO BIPOLAR COAXIAL COAGULATOR (55-P15C/55-P18C/55-P18S/55-P19S/55-P20S)
K972749 · HQR
C.M. Chance , Ltd.
Ophthalmic · 233d
Cleared Mar 11, 1998
SOFLENS(TM) ONE DAY DISPOSABLE (HILAFILCON A) VISIBILITY TINTED CONTACT LENS
K974780 · LPL
Bausch & Lomb, Inc.
Ophthalmic · 79d