FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

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

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175,820 results
22489–22512 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared CT Jul 24, 2019
Canon OCT-A1
K182942 · OBO
Canon, Inc.
Ophthalmic · 274d
Cleared Jul 24, 2019
MaxiTears Contacts PF
K182984 · MRC
Omnivision AG
Ophthalmic · 268d
Cleared Jul 24, 2019
4CIS® Chiron Spinal Fixation System
K190471 · NKB
Solco Biomedical Co., Ltd.
Orthopedic · 148d
Cleared Jul 24, 2019
Coolrail Linear Pen
K190587 · OCL
AtriCure, Inc.
Cardiovascular · 139d
Cleared Jul 24, 2019
TempSure
K190678 · GEI
Cynosure, Inc.
General & Plastic Surgery · 128d
Cleared Jul 24, 2019
ExcelsiusGPS Spine 1.1 Interbody Module
K191100 · OLO
Globus Medical, Inc.
Orthopedic · 90d
Cleared Jul 24, 2019
Discovery XR656 HD with VolumeRad
K191699 · KPR
Ge Hualun Medical Systems Co. , Ltd.
Radiology · 29d
Cleared Jul 24, 2019
Cobas Influenza A/B Nucleic Acid Test for Use on the Cobas Liat System
K191729 · OCC
Roche Molecular Systems, Inc.
Microbiology · 27d
Cleared Jul 23, 2019
ProLift Expandable System
K190488 · MAX
Life Spine, Inc.
Orthopedic · 145d
Cleared Jul 23, 2019
Hammertoe Truss System (HTS)
K190926 · HTY
4Web, Inc.
Orthopedic · 105d
Cleared Jul 23, 2019
DePuy Synthes Craniomaxillofacial Sternal Devices - MR Conditional
K190963 · HRS
Synthes USA Products, LLC
Orthopedic · 102d
Cleared Jul 23, 2019
Vantage Orian 1.5T, MRT-1550, V4.5
K191662 · LNH
Canon Medical Systems Corporation
Radiology · 32d
Cleared Jul 22, 2019
CottonDay Tampon
K182817 · HEB
Taebong Co., Ltd.
Obstetrics & Gynecology · 292d
Cleared Jul 22, 2019
Roadrunner PC Wire Guide, Olcott Torque Device
K182985 · DQX
Cook Incorporated
Cardiovascular · 266d
Cleared Jul 22, 2019
Corin Optimized Position System Functional Hip Analysis (OPS FHA)
K190834 · LZO
Corin USA
Orthopedic · 112d
Cleared Jul 22, 2019
Plexus SCD110 Sequential Compression Device Sleeve
K190975 · JOW
Midway Medical, LLC
Cardiovascular · 98d
Cleared Jul 22, 2019
BAROnova Access Sheath Kit
K191078 · QGG
Baronova, Inc.
Gastroenterology & Urology · 90d
Cleared Jul 22, 2019
Powder-Free Vinyl Patient Examination Gloves, Yellow Color
K191092 · LYZ
Anhui Intco Medical Products Co., Ltd.
General Hospital · 89d
Cleared Jul 22, 2019
Revival Modular Hip Stem
K191374 · LZO
Corin U.S.A. Limited
Orthopedic · 60d
Cleared Jul 22, 2019
Digital Automatic Blood Pressure Monitor MD36 Series
K191593 · DXN
Grandway Technology (Shenzhen) Limited
Cardiovascular · 38d
Cleared Jul 20, 2019
CerusEndo Microcatheter
K182487 · DQY
Cerus Endovascular, Inc.
Neurology · 312d
Cleared Jul 20, 2019
CARTO 3 EP Navigation System, Version 7.1 and Accessories
K191660 · DQK
Biosense Webster, Inc.
Cardiovascular · 29d
Cleared Jul 19, 2019
Exceed Microneedling device
K182407 · QAI
Mt. Derm GmbH
General & Plastic Surgery · 318d
Cleared Jul 19, 2019
KIDScore D3
K182798 · PBH
Vitrolife A/S
Obstetrics & Gynecology · 290d