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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
38809–38832 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 23, 2013
EYE SECRET 38 UV ASPHERIC (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS FOR...
K132854 · LPL
Yung Sheng Optical Co., Ltd.
Ophthalmic · 102d
Cleared Dec 23, 2013
LIPIFLOW THERMAL PULSATION SYSTEM
K133127 · ORZ
Tearscience, Inc.
Ophthalmic · 84d
Cleared Dec 23, 2013
LAURIMED POLYPVAC MICRODEBRIDER
K133133 · ERL
Laurimed, LLC
Ear, Nose, Throat · 84d
Cleared Dec 23, 2013
AVAIRA SPHERIC AND TORIC (ENFILCON A) SOFT CONTACT LENS
K133627 · LPL
CooperVision, Inc.
Ophthalmic · 27d
Cleared Dec 23, 2013
SPECTRUM TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER SET
K133634 · LJS
Cook, Inc.
General Hospital · 27d
Cleared Dec 20, 2013
AGGREGUIDE
K122162 · JOZ
Aggredyne, Inc.
Hematology · 518d
Cleared Dec 20, 2013
AIR BARRIER SYSTEM (ABS)
K123006 · ORC
Nimbic Systems, Inc.
General Hospital · 449d
Cleared Dec 20, 2013
TONE-A-MATIC
K130052 · IPF
Tone-A-Matic International, Inc.
Physical Medicine · 345d
Cleared Dec 20, 2013
GENPRIME DRUGS OF ABUSE READER SYSTEM
K130082 · DKZ
Genprime, Inc.
Chemistry · 340d
Cleared Dec 20, 2013
BERNOULLI ENTERPRISE SOFTWARE
K130208 · MHX
Cardiopulmonary Corp.
Cardiovascular · 326d
Cleared Dec 20, 2013
ON CALL SHARP BLOOD GLUCOSE MONITORING SYSTEM
K130284 · NBW
ACON Laboratories, Inc.
Chemistry · 318d
Cleared Dec 20, 2013
ELECTROTHERAPY DEVICE (COMBO UNIT)
K130691 · IPF
Guangzhou Finecure Medical Equipment...
Physical Medicine · 282d
Cleared Dec 20, 2013
POLYDIMETHYLSILOXANE IMPRESSION MATERIAL
K131510 · ELW
Blackwell Device Consulting
Dental · 210d
Cleared Dec 20, 2013
ECOM ENDOTRACHEAL CARDIAC OUTPUT MONITOR SYSTEM
K131765 · DSB
Conmed Corporation
Cardiovascular · 186d
Cleared Dec 20, 2013
KC 300 SURGICAL MASK
K131879 · FXX
Kimberly-Clark Corp.
General Hospital · 179d
Cleared Dec 20, 2013
ELECTRONIC PULSE MASSAGER
K131933 · NUH
Gurin Products, LLC
Neurology · 176d
Cleared Dec 20, 2013
ELISIO-H HEMODIALYZER, ELISIO-M HEMODIALYZER
K131935 · KDI
Nipro Medical Corporation
Gastroenterology & Urology · 176d
Cleared Dec 20, 2013
IMAGE1 SPIES
K131953 · FET
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 176d
Cleared Dec 20, 2013
V SERIES MONITORING SYSTEM, 12.1 DCU/V12 AND 21.0 DCU/V21
K132026 · MHX
Mindray DS USA, Inc.
Neurology · 172d
Cleared Dec 20, 2013
MULTI ANGLED ABUTMENT SYSTEM
K132067 · NHA
Hiossen, Inc.
Dental · 170d
Cleared Dec 20, 2013
BARLE TISSUE ADHESIVE 2
K132243 · MPN
Advanced Medical Solutions...
General & Plastic Surgery · 155d
Cleared Dec 20, 2013
NIVATOPIC PLUS
K132329 · FRO
Nivagen Pharmaceuticals, Inc.
General & Plastic Surgery · 147d
Cleared Dec 20, 2013
XVWEB
K132342 · LLZ
Apteryx, Inc.
Radiology · 147d
Cleared Dec 20, 2013
IDEAL
K132428 · HSB
Jiangsu Ideal Medical Science &...
Orthopedic · 137d