FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
111937–111960 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 20, 1993
ROLLENS POST-MYDRIATIC SUNGLASS
K932646 · HQY
Rollens Professional Products, Inc.
Ophthalmic · 110d
Cleared Sep 20, 1993
FRAMES, SPECTACLES
K932772 · HQZ
Optical Designs and Sourcing, Inc.
Ophthalmic · 104d
Cleared Sep 20, 1993
FRAMES, SPECTACLES
K932773 · HQZ
Diaco, Inc.
Ophthalmic · 104d
Cleared Sep 20, 1993
PULPDENT EDTA PREPARATIONS
K932791 · KIF
Pulpdent Corp.
Dental · 103d
Cleared Sep 20, 1993
PULPDENT SEAL-RITE LOW VISCOSITY
K932794 · EBC
Pulpdent Corp.
Dental · 103d
Cleared Sep 20, 1993
NON-PRESCRIPTION SUGLASSES
K932814 · HQY
Sun Style Intl. Corp.
Ophthalmic · 103d
Cleared Sep 20, 1993
SUNGLASSES
K932939 · HQY
Soft-Ray Optical Corp.
Ophthalmic · 96d
Cleared Sep 20, 1993
SUNGLASSES
K932940 · HQY
Sun and Young Sunglasses Co., Ltd.
Ophthalmic · 96d
Cleared Sep 20, 1993
SUNGLASSES
K932941 · HQY
Rayman Speco Co., Ltd.
Ophthalmic · 96d
Cleared Sep 20, 1993
CERVICAL TRACTION STRAP
K933023 · KPR
Cook (Canada), Inc.
Radiology · 90d
Cleared Sep 20, 1993
SUNGLASSES
K933074 · HQZ
P.T. Sun and Young Indonesia Sunglasses
Ophthalmic · 89d
Cleared Sep 20, 1993
MEDICAL IMAGE MANAGEMENT SYSTEM/X-RAY TERMINAL
K933098 · LMD
Siemens Medical Solutions Health...
Radiology · 88d
Cleared Sep 20, 1993
EYEGLASS FRAMES
K933254 · HQY
Sam Chung Optical Co., Ltd.
Ophthalmic · 80d
Cleared Sep 20, 1993
STETSON/S.LOREN/LH.BAZAAR/G.VANDERBILT/P.BALMAIN
K933423 · HQZ
Thunder Industries, Inc.
Ophthalmic · 69d
Cleared Sep 20, 1993
STETSON/S.LOREN/H.BAZAAR/G.VANDERBILT/P.BALMAIN
K933424 · HQZ
Zyloware Corp.
Ophthalmic · 69d
Cleared Sep 20, 1993
MULTIPLE
K933616 · HQY
Greg and Greg, Inc.
Ophthalmic · 63d
Cleared Sep 20, 1993
MARCHON/MARCOLIN SUNGLASSES
K933734 · HQY
Marchon Eyewear, Inc.
Ophthalmic · 49d
Cleared Sep 20, 1993
CHENOWETH-FRANK RADIOPATHOLOGICAL GRID
K933754 · IZH
Cook, Inc.
Radiology · 48d
Cleared Sep 20, 1993
SPECTACLE FRAME
K933874 · HQZ
Designer Frames
Ophthalmic · 45d
Cleared Sep 18, 1993
AS-90
K923006 · ESD
Qualitone
Ear, Nose, Throat · 453d
Cleared Sep 17, 1993
OSCILLOMATE BLOOD PRESSURE MONITOR-MODEL 9300
K925402 · DXN
Cas Medical Systems, Inc.
Cardiovascular · 329d
Cleared Sep 17, 1993
U.C.E.Z. LENS CLEANER KIT
K925659 · OCT
Anago, Inc.
Gastroenterology & Urology · 345d
Cleared Sep 17, 1993
VOLUME TRANSDUCER
K931282 · EXQ
Life-Tech Intl., Inc.
Gastroenterology & Urology · 189d
Cleared Sep 17, 1993
AVE ALLIANCE DILATATION CATHETER
K931384 · LIT
Applied Vascular Engineering, Inc.
Cardiovascular · 183d