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
38809–38832 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 06, 2014
O2 NASAL CANNULA WITH CO2 MONITORING
K140113 · CCK
Flexicare Medical, Ltd.
Anesthesiology · 50d
Cleared Mar 06, 2014
VENTRIPOINT MEDICAL SYSTEM
K140153 · IYN
Ventripoint, Inc.
Radiology · 43d
Cleared Mar 05, 2014
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
K130751 · LYZ
Cabin Plastic Co., Ltd.
General Hospital · 351d
Cleared Mar 05, 2014
CONTEC ELECTROCARDIOGRAPH
K131900 · DPS
Contec Medical System Co., Ltd.
Cardiovascular · 253d
Cleared Mar 05, 2014
ISENS (POLYMACON) SPHERICAL AND TORIC DAILY WEAR SOFT CONTACT LENSES (CLEAR,...
K132714 · LPL
Vision Science Co., Ltd.
Ophthalmic · 187d
Cleared Mar 05, 2014
VELOFIXTM INTERBODY FUSION SYSTEM
K132926 · ODP
U&I Corp.
Orthopedic · 168d
Cleared Mar 05, 2014
REVLITE Q-SWITCHED ND:YAG LASER SYSTEM
K133254 · GEX
Cynosure, Inc.
General & Plastic Surgery · 134d
Cleared Mar 05, 2014
ALLURA XPER FD
K133292 · OWB
Philips Medical Systems Nederland B.V.
Radiology · 131d
Cleared Mar 05, 2014
ANGIOVAC CANNULA
K133445 · DWF
Vortex Medical, Inc.
Cardiovascular · 113d
Cleared Mar 05, 2014
DIGITAL AUTOMATIC WRIST BLOOD PRESSURE MONITOR WBPM22 SERIES
K133618 · DXN
Grandway Technology (Shenzhen) Limited
Cardiovascular · 100d
Cleared Mar 05, 2014
DIGITAL AUTOMATIC BLOOD PRESSURE MONITOR BPM18 SERIES
K133619 · DXN
Grandway Technology (Shenzhen) Limited
Cardiovascular · 100d
Cleared CT Mar 05, 2014
SAUFLON CLARITI WITH TINT, SAUFLON CLARITI TORIC WITH TINT, SAUFLON CLARITI...
K133740 · LPL
Sauflon Pharmaceuticals, Ltd.
Ophthalmic · 86d
Cleared Mar 05, 2014
FERM-FLEX AND FEM-FLEX II ( FEMORAL ACCESS ARTERIAL CANNULAE) FEMTRAK,VFEM,...
K140208 · DWF
Edwards Lifesciences, LLC
Cardiovascular · 36d
Cleared Mar 05, 2014
IMMULITE 2000 DHEA-SO4
K140258 · JJX
Siemens Healthcare Diagnostics, Inc.
Chemistry · 30d
Cleared Mar 05, 2014
INSUFLOW SYNERGY PORT, INSUFLOW SYNERGY XL PORT
K140263 · HIF
Lexion Medical, LLC
Obstetrics & Gynecology · 30d
Cleared Mar 05, 2014
NMI PICC IV
K140266 · LJS
Navilyst Medical, Inc.
General Hospital · 30d
Cleared Mar 04, 2014
HEALTHSTATS A-PULSE CASPAL + AND MC3100+ MONITORS AND MY-BP BP MANAGEMENT...
K131788 · DXN
Healthstats International Pte. , Ltd.
Cardiovascular · 259d
Cleared Mar 04, 2014
TRUPOINT ARCH, NASION CUSHION, BITE CUP, TRUPOINT ARCH STORAGE PLATE,...
K132908 · IYE
Medtec, Inc.
Radiology · 168d
Cleared Mar 04, 2014
NOVOPORE DRESSING
K132936 · OMP
Polynovo Biomaterials Pty, Ltd.
General & Plastic Surgery · 167d
Cleared Mar 04, 2014
RITHM ID ELECTROPHYSIOLOGY CATHETER
K133028 · DRF
Synaptic Medical Limited
Cardiovascular · 159d
Cleared Mar 04, 2014
ANDON BLOOD PRESSURE CUFF
K133117 · DXQ
Andon Health Co, Ltd.
Cardiovascular · 155d
Cleared Mar 04, 2014
ZIMMER DENTAL TAPERED SCREW VENT T IMPLANT, HA COATED
K133339 · DZE
Zimmer Dental, Inc.
Dental · 125d
Cleared Mar 04, 2014
HEM-7320
K133383 · DXN
Omron Healthcare, Inc.
Cardiovascular · 120d
Cleared CT Mar 04, 2014
SAUFLON CLARITI 1 DAY WITH TINT (TORIC/MULTIFOCAL)
K133472 · LPL
Souflon Pharmaceuticals, Ltd.
Ophthalmic · 112d