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
30481–30504 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 01, 2016
Phasor Drill
K161704 · HBE
Biotex, Inc.
Neurology · 164d
Cleared Dec 01, 2016
SCIg60 Infuser
K161906 · PKP
Emed Technologies Corporation
General Hospital · 142d
Cleared Dec 01, 2016
RemLogic
K162140 · OLZ
Embla Systems
Neurology · 122d
Cleared Dec 01, 2016
Fiagon Navigation System
K162176 · PGW
Fiagon GmbH
Ear, Nose, Throat · 120d
Cleared Dec 01, 2016
SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion Device
K162351 · OVD
SeaSpine Orthopedics Corporation
Orthopedic · 100d
Cleared Dec 01, 2016
ClearCheck
K162468 · IYE
Radformation
Radiology · 90d
Cleared Dec 01, 2016
Voyant Open Fusion Device
K162676 · GEI
Applied Medical Resources
General & Plastic Surgery · 66d
Cleared Dec 01, 2016
Litho
K163009 · GEX
Quanta System Spa
General & Plastic Surgery · 34d
Cleared Dec 01, 2016
CareView 750Cw/750C X-ray Flat Panel Detectors
K163019 · MQB
Careray Digital Medical System Co., Ltd.
Radiology · 31d
Cleared Dec 01, 2016
Lumipulse G E2-III Calibrators
K163053 · JIT
Fujirebio Diagnostics,Inc.
Chemistry · 30d
Cleared Dec 01, 2016
CyMedica e-vive™ System
K163067 · IPF
Cymedica Orthopedics, Inc.
Physical Medicine · 29d
Cleared Dec 01, 2016
CODMAN Integrated Bipolar Cord and Tubing Set
K163106 · GEI
Medos International SARL
General & Plastic Surgery · 24d
Cleared Nov 30, 2016
HEMASORBPLUS Resorbable Hemostatic Bone Putty
K153317 · MTJ
Orthocon, Inc.
General & Plastic Surgery · 378d
Cleared Nov 30, 2016
Solution Set for Epidural Use
K161323 · FPA
Baxter Healthcare Corporation
General Hospital · 203d
Cleared Nov 30, 2016
DAILIES AquaComfort Plus, DAILIES AquaComfort Plus Toric, DACP Multifocal,...
K161391 · LPL
Alcon Laboratories, Inc.
Ophthalmic · 195d
Cleared Nov 30, 2016
SimplECG
K161431 · DXH
Nanowear, Inc.
Cardiovascular · 190d
Cleared Nov 30, 2016
One Drop Blood Glucose Monitoring System
K161834 · NBW
Agamatrix, Inc.
Chemistry · 148d
Cleared Nov 30, 2016
Protek Solo 24 Fr Venous Cannula Set
K162214 · DWF
Cardiacassist, Inc.
Cardiovascular · 114d
Cleared Nov 30, 2016
ESPADA Acne-Clearing Blue Light Pen
K162450 · OLP
Foreo, Inc.
General & Plastic Surgery · 90d
Cleared Nov 30, 2016
TxRx Knee 15 Flare MR Coil 1.5T
K162966 · MOS
Quality Electrodynamics, LLC
Radiology · 37d
Cleared Nov 30, 2016
Zeramex P6 Dental Implant System
K163043 · DZE
Dentalpoint AG
Dental · 30d
Cleared Nov 30, 2016
TubeClear Control Box and Clearing Stem
K163092 · KNT
Actuated Medical, Inc.
Gastroenterology & Urology · 26d
Cleared Nov 30, 2016
ReliaCatch Specimen Retrieval Bag 10mm
K163102 · GCJ
Covidien
General & Plastic Surgery · 23d
Cleared Nov 30, 2016
Clarius Ultrasound System
K163138 · IYN
Clarius Mobile Health Corp.
Radiology · 21d