Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

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

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175,820 results
32665–32688 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 04, 2016
Sun Capsule 60/160/1.8/6, Sun Capsule 60/220/1.9/6, Sun Capsule 60/225/2.0/6,...
K152238 · LEJ
Sun Capsule, Inc.
General & Plastic Surgery · 207d
Cleared Mar 04, 2016
ASAHI Corsair Armet
K152249 · DQY
Asahi Intecc Co., Ltd.
Cardiovascular · 207d
Cleared Mar 04, 2016
IRTS Thermal Imaging Probe (TIP)
K152402 · FLL
Securus,Inc
General Hospital · 192d
Cleared Mar 04, 2016
IS4000 Stapler 30 Instrument and Stapler 30 Reloads
K152421 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 191d
Cleared Mar 04, 2016
Propeller Sensor Model 2014-R
K152482 · CAF
Reciprocal Labs
Anesthesiology · 186d
Cleared Mar 04, 2016
DNAP Electrode
K152547 · GZL
Ad-Tech Medical Instrument Corporation
Neurology · 178d
Cleared Mar 04, 2016
Aquasil Ultra + Smart Wetting Impression Material
K152861 · ELW
Dentply International, Inc.
Dental · 156d
Cleared Mar 04, 2016
Integra DP Valve Systems (including Burr Hole Reservoirs and Stainless Steel...
K152897 · JXG
Integra LifeSciences Corporation
Neurology · 155d
Cleared Mar 04, 2016
MultiCross Catheter
K152957 · DQY
Roxwood Medical, Inc.
Cardiovascular · 149d
Cleared Mar 04, 2016
Sheathes Ultrasound Probe Covers
K153212 · ITX
Sheathing Technologies, Inc.
Radiology · 120d
Cleared Mar 04, 2016
syngo Application Software VD11
K153346 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 105d
Cleared Mar 04, 2016
Insufflator 50L FM134
K153513 · HIF
W.O.M. World of Medicine GmbH
Obstetrics & Gynecology · 88d
Cleared Mar 04, 2016
Cefaly
K160237 · PCC
Cefaly Technology
Neurology · 32d
Cleared Mar 04, 2016
PROTEK Duo 31 Fr. Veno-Venous Cannula Set
K160257 · DWF
Cardiacassist, Inc.
Cardiovascular · 32d
Cleared Mar 04, 2016
Endophys Pressure Sensing Sheath Kit
K160272 · DYB
Endophys, Inc.
Cardiovascular · 31d
Cleared Mar 04, 2016
Platinum dRF Imaging System
K160301 · JAA
Apelem-Dms Group
Radiology · 29d
Cleared Mar 04, 2016
syngo.via MI Workflows
K160426 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 17d
Cleared Mar 03, 2016
Pac-Dent Barrier Sleeve, Cover-It(TM) Barrier Film
K151123 · PEM
Pac-Dent International, Inc.
Dental · 310d
Cleared Mar 03, 2016
FULL CARE Disposable PVC Nelaton Catheter
K151745 · EZD
Shaoxing Fuqing Health Products Co.,...
Gastroenterology & Urology · 248d
Cleared Mar 03, 2016
IMMULITE 2000 TSI Assay, IMMULITE 2000 TSI Calibration Verification Material
K152061 · JZO
Siemens Healthcare Diagnostics, Inc.
Immunology · 223d
Cleared Mar 03, 2016
Olea Sphere V3.0
K152602 · LLZ
Olea Medical
Radiology · 174d
Cleared Mar 03, 2016
Fujifilm Ultrasonic Processors SU-1 PLATINUM and SU-1
K153206 · FDS
Fujifilm Medical System U.S.A., Inc.
Gastroenterology & Urology · 119d
Cleared Mar 03, 2016
GC Reline II
K153253 · EBI
GC America, Inc.
Dental · 114d
Cleared Mar 03, 2016
Tenex Health TX System
K153299 · LFL
Tenex Health, Inc.
General & Plastic Surgery · 111d