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
41353–41376 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 27, 2013
INION FREEDOMSCREW (ALTERNATIVE MARKETING NAME: INION OTPS FREEDOMSCREW)
K123672 · HWC
Inion OY
Orthopedic · 90d
Cleared Feb 27, 2013
INMODE HAIR REMOVAL (HR) DEVICE
K123682 · GEX
Inmode MD , Ltd.
General & Plastic Surgery · 89d
Cleared Feb 27, 2013
DIGITAL ELECTROCARDIOGRAPHS
K123816 · DPS
Shenzhen Biocare Electronics Co., Ltd.
Cardiovascular · 77d
Cleared Feb 27, 2013
QUATTRO AIR
K123979 · BZD
Resmed, Ltd.
Anesthesiology · 63d
Cleared Feb 27, 2013
PICCOLO COMPOSITE PLATE SYSTEM
K130061 · HRS
CarboFix Orthopedics , Ltd.
Orthopedic · 48d
Cleared Feb 27, 2013
SIMMETRY SACROILIAC JOINT FUSION SYSTEM
K130092 · OUR
Zyga Technology, Inc.
Orthopedic · 43d
Cleared Feb 27, 2013
SPEEDLOCK KNOTLESS FIXATION DEVICE, 3MM DRILL, 3MM+ DRILL, PATHFINDER...
K130196 · MBI
Arthrocare Corp.
Orthopedic · 30d
Cleared Feb 27, 2013
BD PHASEAL CLOSED SYSTEM TRANSFER DEVICE - P55
K130197 · ONB
Becton, Dickinson and Company
General Hospital · 30d
Cleared Feb 26, 2013
QUANTA FLASH ACL LGA, QUANTA FLASH B2GP1 IGA
K120817 · MID
Inova Diagnostics, Inc.
Immunology · 344d
Cleared Feb 26, 2013
BRIDGE EXTRACELLULAR COLLEGEN MATRIX
K122502 · KGN
Harbor Medtech, Inc.
General & Plastic Surgery · 194d
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