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
105625–105648 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 22, 1994
1710 MONITORING ECG ELECTRODE
K944726 · DRX
Conmed Andover Medical, Inc.
Cardiovascular · 57d
Cleared Nov 22, 1994
KARL STORZ INSULATED CANNULAE, SUCTION TUBES
K944797 · EOB
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 55d
Cleared Nov 22, 1994
TOMEY EM-1000 SPECULAR MICROSCOPE
K944910 · HJO
Tomey Corporation USA
Ophthalmic · 48d
Cleared Nov 22, 1994
AXIOM, SUNFAST
K944915 · HQY
Axiom Ent. Co., Ltd.
Ophthalmic · 47d
Cleared Nov 22, 1994
OPTIMA DELIVERY BED (MODELS 33901, 33903, 33902, 33905)
K944929 · FNK
Merivaara Instrumentarium Corp.
General Hospital · 47d
Cleared Nov 22, 1994
NON-PRESCRIPTION SUNGLASSES
K944996 · HQY
La Kinglong Intl., Inc.
Ophthalmic · 40d
Cleared Nov 22, 1994
BRIGHTEN
K945036 · HQY
New Daley Intl. Trading Co.
Ophthalmic · 40d
Cleared Nov 22, 1994
MCI OPTONIX CASSETTE OKAMOTO CASSETE
K945039 · IXA
Mci Optonix, Inc.
Radiology · 39d
Cleared Nov 22, 1994
MICROMED PARTIAL REGULAR AND PARTIAL OFFSET
K945104 · ETB
Micromed Development Corp.
Ear, Nose, Throat · 35d
Cleared Nov 22, 1994
MICROMED TOTAL REGULAR AND PARTIAL OFFSET
K945106 · ETA
Micromed Development Corp.
Ear, Nose, Throat · 35d
Cleared Nov 22, 1994
POLY-WIRE PISTON
K945107 · ETB
Micromed Development Corp.
Ear, Nose, Throat · 35d
Cleared Nov 22, 1994
POLY PISTON
K945108 · ETB
Micromed Development Corp.
Ear, Nose, Throat · 35d
Cleared Nov 22, 1994
ARISTAR EYEWEAR, ESPRIT EYEWEAR
K945122 · HQY
Aristar Inc. U.S.A.
Ophthalmic · 34d
Cleared Nov 22, 1994
ARISTAR EYEWEAR, ESPRIT EYEWEAR
K945123 · HQZ
Aristar Inc. U.S.A.
Ophthalmic · 34d
Cleared Nov 22, 1994
BREAST LESION LOCALIZATION NEEDLE
K945124 · GDF
Promex, Inc.
General & Plastic Surgery · 34d
Cleared Nov 22, 1994
RED DRAGON CORPORATION
K945249 · HQY
J C Intl., Inc.
Ophthalmic · 25d
Cleared Nov 22, 1994
SPECTACLE FRAME
K945323 · HQZ
M.Y. Vision Corp.
Ophthalmic · 21d
Cleared Nov 22, 1994
SPECTACLE FRAMES OR EYEGLASS FRAMES
K945340 · HQZ
Mi Mun Corp.
Ophthalmic · 21d
Cleared Nov 22, 1994
MAKROLON 2405 GOGGLES (LIGHT AND DARK)
K945346 · HOY
Universal Massage & Tanning, Inc.
Ophthalmic · 20d
Cleared Nov 22, 1994
LAPAROSCOPIC SURGICAL INSTRUMENTS FOR GENERAL USE
K945369 · GCJ
Advanced Surgical, Inc.
General & Plastic Surgery · 89d
Cleared Nov 22, 1994
'LIL MAC ACCESSORY CLAMP(TM)
K945415 · FWZ
D.L. Nelson and Assoc., Inc.
General & Plastic Surgery · 15d
Cleared Nov 22, 1994
EDI-BUR MICRODRILL SYSTEMS
K945438 · ERL
Micromed Development Corp.
Ear, Nose, Throat · 33d
Cleared Nov 22, 1994
FRAME, SPECTACLE
K945450 · HQZ
Kookje Apis Industrial Co.
Ophthalmic · 19d
Cleared Nov 21, 1994
DAKO MOUSE ANTI-HUMAN T-CELL
K924804 · DEH
Dako Corp.
Immunology · 788d