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
41953–41976 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 26, 2013
HEINE OMEGA 500
K123316 · HLI
Heine Optotechnik GmbH & Co. KG
Ophthalmic · 124d
Cleared Feb 26, 2013
CEDARS-SINAI CARDIAC SUITE NUCLEAR MEDICINE SOFTWARE
K123433 · KPS
Cedars-Sinai Medical Center
Radiology · 111d
Cleared Feb 26, 2013
ARTIS Q AND Q.ZEN- MODULAR ANGIOGRAPHIC SYSTEM
K123529 · OWB
Siemens Medical Solutions USA, Inc.
Radiology · 102d
Cleared Feb 26, 2013
ORTHOCORD
K123668 · NEW
Depuy Mitek, Inc., A Johnson and...
General & Plastic Surgery · 89d
Cleared Feb 26, 2013
OSTAVI HYDROPHILIC GUIDEWIRE
K124052 · OCY
Lake Region Medical
Gastroenterology & Urology · 57d
Cleared Feb 25, 2013
VITREA CT TRANSCATHETER AORTIC VALVE REPLACMENT (TAVR) PLANNING
K122578 · LLZ
Vital Images, Inc.
Radiology · 186d
Cleared Feb 25, 2013
ACHILLES
K123238 · MUA
Ge Medical Systems China Co., Ltd.
Radiology · 132d
Cleared Feb 25, 2013
THE ARTAS SYSTEM
K123548 · ONA
Restoration Robotics, Inc.
General & Plastic Surgery · 98d
Cleared Feb 25, 2013
POLARIS SPINAL SYSTEM - BALLISTA II PERCUTANEOUS SCREW PLACEMENT SYSTEM
K123549 · NKB
Biomet Spine (Aka Ebi, LLC)
Orthopedic · 98d
Cleared Feb 25, 2013
VERTEX RECONSTRUCTION SYSTEM, VERTEX SELECT RECONSTRUCTION SYSTEM
K123656 · KWP
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 89d
Cleared Feb 22, 2013
OPTOS OCT/SLO MICROPERIMETER
K121043 · OBO
Optos Plc.
Ophthalmic · 323d
Cleared Feb 22, 2013
ZI BLOWER
K121374 · BZD
Deshum Medical
Anesthesiology · 291d
Cleared Feb 22, 2013
INCLUSIVE TAPERED IMPLANT SYSTEM
K121406 · DZE
Prismatik Dentalcraft, Inc.
Dental · 288d
Cleared Feb 22, 2013
SILKN BLUE
K121435 · OLP
Home Skinovations , Ltd.
General & Plastic Surgery · 284d
Cleared Feb 22, 2013
MYVISIONTRACK(TM)
K121738 · HOQ
Vital Art and Science Incorporated
Ophthalmic · 254d
Cleared Feb 22, 2013
CALCIUM HYDROXYLAPATITE VOCAL FOLD IMPLANT
K121795 · MIX
Cytophil, Inc.
Ear, Nose, Throat · 248d
Cleared Feb 22, 2013
DISTAL FEMORAL GROWING PROSTHESIS, TIBIAL ROTATING COMPONENTS, BEARING, AXIS,...
K122015 · KRO
Howmedica Osteonics Corp.
Orthopedic · 227d
Cleared Feb 22, 2013
U-MOTION II ACETABULAR SYSTEM
K122185 · LZO
United Orthopedic Corp.
Orthopedic · 214d
Cleared Feb 22, 2013
MAMMOMAL INSPIRATION
K122286 · MUE
Siemens Medical Solutions USA, Inc.
Radiology · 207d
Cleared Feb 22, 2013
T:CONNECT DATA MANAGEMENT SYSTEM
K122361 · OUG
Tandem Diabetes Care, Inc.
General Hospital · 203d
Cleared Feb 22, 2013
VPULSE
K122640 · JOW
Cothera, LLC
Cardiovascular · 177d
Cleared Feb 22, 2013
LIFESTYLES WARM LOVIN PERSONAL LUBRICANT
K122720 · NUC
Ansell Healthcare Products, LLC
Obstetrics & Gynecology · 170d
Cleared Feb 22, 2013
BLUE STERILE POWDER FREE NITRILE EXAMINATION GLOVE
K122727 · LZA
Northstar Healthcare Holdings
General Hospital · 170d
Cleared Feb 22, 2013
RETROGRADE CORONARY SINUS CARDIOPLEGIA CATHETER, RETROGRADE CARDIOPLEGIA...
K123187 · DWF
Edwards Lifesciences, LLC
Cardiovascular · 134d