Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
41545–41568 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared CT Apr 10, 2013
JETSTREAM XC 2.4/3.4 SYSTEM
K130637 · MCW
Medrad, Inc.
Cardiovascular · 30d
Cleared Apr 10, 2013
CD HORIZON SPINAL SYSTEM
K130646 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 30d
Cleared Apr 09, 2013
EUROIMMUN ANTI-ENA POOL ELISA (IGG)
K112996 · LLL
Euroimmun US
Immunology · 550d
Cleared Apr 09, 2013
2004-OC MASSAGE SYSTEM, 2008-OC MASSAGE SYSTEM
K122112 · IRP
Bio Compression Systems, Inc.
Physical Medicine · 266d
Cleared Apr 09, 2013
ATTAIN COMMAND+SUREVALVE LEFT HEART DELIVERY SYSTEM ATTAIN COMMAND GUIDE...
K123153 · DQY
Medtronic, Ireland
Cardiovascular · 182d
Cleared Apr 09, 2013
WARMING JELLY PERSONAL LUBRICANT
K123770 · NUC
Wisconsin Pharmacal Co., LLC
Obstetrics & Gynecology · 123d
Cleared Apr 09, 2013
STRYKER UNIVERSAL ORBITAL FLOOR SYSTEM
K123786 · JEY
Stryker
Dental · 120d
Cleared Apr 09, 2013
PSA SERIES
K123916 · DTE
Osypka Medical, Inc.
Cardiovascular · 111d
Cleared Apr 09, 2013
CAPSTONE L SPINAL SYSTEM
K123978 · MAX
Medtronic Sofamor Danek USA
Orthopedic · 104d
Cleared Apr 09, 2013
RADIAL-CUF NON-INVASIVE BLOOD PRESSURE CUFF
K123996 · DXQ
Ge Medical Systems Information...
Cardiovascular · 104d
Cleared CT Apr 09, 2013
GORE ACUSEAL VASCULAR GRAFT
K130215 · DSY
W.L. Gore & Associates, Inc.
Cardiovascular · 70d
Cleared Apr 09, 2013
LIAISON ALDOSTERONE, LIAISON ALDOSTERONE CONTROL SET, LIAISON ALDOSTERONE...
K130321 · CJM
Diasorin
Chemistry · 60d
Cleared Apr 09, 2013
CLEARFIL MAJESTY ES FLOW
K130371 · EBF
Kuraray Noritake Dental, Inc.
Dental · 54d
Cleared Apr 09, 2013
SYNAPSE 3D CARDIAC TOOLS
K130383 · LLZ
Fujifilm Medical System U.S.A., Inc.
Radiology · 54d
Cleared Apr 09, 2013
DEVON CIRONA 6100 DVT
K130571 · JOW
Devon Medical, Inc.
Cardiovascular · 36d
Cleared Apr 09, 2013
WONDOFO MULTI-DRUG URINE TEST CUP / PANEL
K130665 · DJG
Guangzhou Wondfo Biotech Co., Ltd.
Toxicology · 28d
Cleared Apr 08, 2013
XP200
K122966 · GEI
Btl Industries, Ltd.
General & Plastic Surgery · 195d
Cleared Apr 08, 2013
INCORIS ZI
K123664 · EIH
Sirona Dental Systems GmbH
Dental · 131d
Cleared Apr 08, 2013
OTOMAG BONE CONDUCTION HEARING SYSTEM
K123962 · LXB
Sophono, Inc.
Ear, Nose, Throat · 103d
Cleared Apr 05, 2013
SIMPLI SIMPLER IMPLANT SYSTEM
K121281 · DZE
Simpler Implant Solutions
Dental · 340d
Cleared Apr 05, 2013
NUK EXPRESSIVETM DOUBLE ELECTRIC BREAST PUMP
K121478 · HGX
Mapa GmbH
Obstetrics & Gynecology · 322d
Cleared Apr 05, 2013
NEUROPRO LOW PROFILE CRANIAL PLATING SYSTEM
K122049 · GWO
Kinamed, Inc.
Neurology · 267d
Cleared Apr 05, 2013
6.00MM X 6.00MM MACRO EXTERNAL IMPLANT SYSTEM
K122198 · DZE
Oco Biomedical
Dental · 255d
Cleared Apr 05, 2013
DIAVUE PRUDENTIAL BLOOD GLUCOSE MONITORING SYSTEM
K122307 · NBW
Biocare Corporation
Chemistry · 247d