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
19705–19728 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 02, 2020
VenaOne
K200285 · JOW
Vena Group, LLC
Cardiovascular · 148d
Cleared Jul 02, 2020
AtriAmp, AtriAmp - Pacing Cable Medtronic Connector, AtriAmp - Pacing Cable...
K200674 · DSA
Atrility Medical, LLC
Cardiovascular · 108d
Cleared Jul 02, 2020
3M Attest Steam Chemical Integrator Test Pack
K200766 · FRC
3M Company
General Hospital · 99d
Cleared Jul 02, 2020
Agape Cooling Personal Lubricant
K200894 · NUC
CC Wellness, LLC
Obstetrics & Gynecology · 90d
Cleared Jul 02, 2020
InMode System with the Morhpeus8 Applicators
K200947 · GEI
Inmode , Ltd.
General & Plastic Surgery · 85d
Cleared Jul 02, 2020
SherpaPak Pediatric Liver Transport System
K201048 · KDN
Paragonix Technologies
Gastroenterology & Urology · 72d
Cleared Jul 02, 2020
Traxcess 7 Mini Guidewire
K201487 · MOF
MicroVention, Inc.
Neurology · 28d
Cleared Jul 02, 2020
2MP Color/Monochrome LCD Monitors C22S+, C22SP+/G22S+, G22SP+, G23S+, G23SP+
K201599 · PGY
Shenzhen Beacon Display Technology...
Radiology · 20d
Cleared Jul 02, 2020
Terason uSmart 3200T Plus Ultrasound System
K201633 · IYN
Teratech Corporation
Radiology · 16d
Cleared Jul 01, 2020
Versana Premier
K200138 · IYN
Ge Medical Systems Ultrasound And
Radiology · 162d
Cleared Jul 01, 2020
Allwin Embryo Transfer Catheters (ETC), Allwin ETC Stylets and Soft Obturators
K200248 · MQF
Allwin Medical Devices, Inc.
Obstetrics & Gynecology · 152d
Cleared Jul 01, 2020
StimPlus Patch, StimPlus Patch, StimPlus Patch
K200561 · NUH
Jkh Health Co., Ltd.
Neurology · 119d
Cleared Jul 01, 2020
T2 Tibial Nailing System, T2 Femoral Nail System, T2 Supracondylar Nail...
K200880 · HSB
Stryker GmbH
Orthopedic · 90d
Cleared Jul 01, 2020
SimuPlus Flexible Annuloplasty Ring, SimuPlus Flexible Annuloplasty Band,...
K201449 · KRH
Medtronic, Inc.
Cardiovascular · 30d
Cleared Jul 01, 2020
syngo.via View&GO
K201477 · LLZ
Siemens Healthcare GmbH
Radiology · 28d
Cleared Jun 30, 2020
Dental Electrical Motor iRoot Pro
K191276 · EKX
Changzhou Bomedent Medical Technology...
Dental · 414d
Cleared Jun 30, 2020
Kinos Axiom Total Ankle System
K192778 · HSN
Kinos Medical
Orthopedic · 274d
Cleared Jun 30, 2020
LassoStar Circular Mapping Catheter
K193632 · DRF
Biosense Webster, Inc.
Cardiovascular · 186d
Cleared Jun 30, 2020
Surgical Drills
K200265 · DZI
Implant Direct Sybron Manufacturing, LLC
Dental · 148d
Cleared Jun 30, 2020
Terragene Chemdye
K200272 · JOJ
Terragene S.A.
General Hospital · 147d
Cleared Jun 30, 2020
TruView Light Cable, TruView Lateral Retractor Light Cable, Bifurcated Light...
K200874 · FST
Innovasis, Inc.
General & Plastic Surgery · 90d
Cleared Jun 30, 2020
Litho 150, Cyber Ho 150
K201455 · GEX
Quanta System Spa
General & Plastic Surgery · 29d
Cleared Jun 30, 2020
Altapore MIS
K201464 · MQV
Baxter Healthcare Corporation
Orthopedic · 28d
Cleared Jun 29, 2020
H500 Multi-Sensing Oximetry System
K192900 · DQA
Nonin Medical, Inc.
Anesthesiology · 258d