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
22345–22368 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 09, 2019
Turnpike Catheter
K191560 · DQY
Vascular Solutions, LLC
Cardiovascular · 57d
Cleared Aug 09, 2019
Versana Balance
K191792 · IYN
GE Medical Systems Ultrasound and...
Radiology · 37d
Cleared Aug 09, 2019
Versana Active
K191798 · IYN
GE Medical Systems Ultrasound and...
Radiology · 37d
Cleared Aug 09, 2019
DR 100s
K191884 · IZL
Agfa N.V.
Radiology · 25d
Cleared Aug 08, 2019
Transit-Pellets
K181760 · FFX
Medifactia AB
Gastroenterology & Urology · 401d
Cleared Aug 08, 2019
Conformity Stem
K183312 · LZO
United Orthopedic Corporation
Orthopedic · 252d
Cleared Aug 08, 2019
CoLink Plating System, Fracture and Correction System, RTS Implant System,...
K190385 · HRS
In2bones USA, LLC
Orthopedic · 170d
Cleared Aug 08, 2019
iTotal Identity Cruciate Retaining Knee Replacement System
K190562 · JWH
Conformis, Inc.
Orthopedic · 156d
Cleared CT Aug 08, 2019
REFRESH RELIEVA For CONTACTS
K190674 · LPN
Allergan, Inc.
Ophthalmic · 146d
Cleared Aug 08, 2019
Streamline 6491 Unipolar Pediatric Temporary Pacing Lead, Streamline 6492...
K190716 · LDF
Medtronic
Cardiovascular · 142d
Cleared Aug 08, 2019
Erchonia EVRL
K191257 · NHN
Erchonia Corporation
General & Plastic Surgery · 90d
Cleared CT Aug 08, 2019
binx health io CT/NG Assay
K191352 · QEP
Binx Health, Inc.
Microbiology · 80d
Cleared Aug 08, 2019
ARx Spinal System
K191575 · NKB
Life Spine, Inc.
Orthopedic · 55d
Cleared Aug 07, 2019
7D Surgical System
K183276 · HAW
7D Surgical, Inc.
Orthopedic · 257d
Cleared Aug 07, 2019
Revolution Centrifugal Blood Pump
K190650 · KFM
Sorin Group Italia S.R.L.
Cardiovascular · 147d
Cleared Aug 07, 2019
Elevation Spine Saber-C System
K190885 · OVE
Elevation Spine
Orthopedic · 125d
Cleared Aug 07, 2019
Non-invasive Hemodynamic Blood Pressure Monitor
K190893 · DXN
Vita-Course Technologies Co., Ltd.
Cardiovascular · 124d
Cleared Aug 07, 2019
Navigated Pedicle Access Kit
K191012 · OLO
Izi Medical Products, LLC
Orthopedic · 113d
Cleared Aug 07, 2019
BonAlive Granules
K191274 · MQV
Bonalive Biomaterials, Ltd.
Orthopedic · 86d
Cleared Aug 07, 2019
ILLUMISITE Platform
K191394 · JAK
Covidien, LLC
Radiology · 75d
Cleared Aug 07, 2019
RenovoCath
K191606 · MJN
Renovorx, Inc.
Cardiovascular · 51d
Cleared Aug 07, 2019
Peripheral Intravascular Lithotripsy (IVL) Catheters, IVL Generator and...
K191840 · PPN
Shockwave Medical, Inc.
Cardiovascular · 29d
Cleared Aug 07, 2019
Accurate Multi Panel Drug Urine Test Cup
K191841 · NFT
Healstone Biotech, Inc.
Toxicology · 29d
Cleared Aug 07, 2019
15F iSLEEVE Introducer Set, 14F iSLEEVE Introducer Set
K191871 · DYB
Boston Scientific Corporation
Cardiovascular · 26d