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
23665–23688 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 25, 2019
CAPERE Thrombectomy System
K183179 · QEW
Vascular Medcure, Inc.
Cardiovascular · 101d
Cleared Feb 25, 2019
Bashir Endovascular Catheter Model 7201, Bashir N-X Endovascular Catheter,...
K183290 · QEY
Thrombolex, Inc.
Cardiovascular · 91d
Cleared Feb 25, 2019
Zap-X Radiosurgery System
K183698 · IYE
Zap Surgical Systems
Radiology · 56d
Cleared Feb 25, 2019
Perla® Posterior Cervico-Thoracic Fixation System
K190071 · NKG
Spineart
Orthopedic · 41d
Cleared Feb 25, 2019
COBRA Fusion Ablation System
K190151 · OCL
AtriCure, Inc.
Cardiovascular · 26d
Cleared Feb 22, 2019
HeartCheck Cardi Beat ECG Monitor with GEMS Mobile
K181310 · DXH
Cardiocomm Solutions, Inc.
Cardiovascular · 281d
Cleared Feb 22, 2019
DAVID One Step Home Use Pregnancy Test Midstream, DAVID One Step Home Use...
K181551 · LCX
Runbio Biotech Co.,Ltd
Chemistry · 254d
Cleared Feb 22, 2019
Altus Spine Interbody Fusion System
K182406 · MAX
Altus Partners, LLC
Orthopedic · 171d
Cleared Feb 22, 2019
Reprocessed Response Diagnostic Electrophysiology Catheter
K182488 · NLH
Innovative Health, LLC
Cardiovascular · 164d
Cleared Feb 22, 2019
The EPAD 2 System
K182542 · GWF
Safeop Surgical, Inc.
Neurology · 158d
Cleared Feb 22, 2019
IRIS 1.0 System
K182643 · LLZ
Intuitive Surgical
Radiology · 151d
Cleared Feb 22, 2019
FUJIFILM Ultrasonic Endoscope
K182825 · EOQ
Fujifilm Corporation
Ear, Nose, Throat · 141d
Cleared Feb 22, 2019
Babyleo TN500
K182859 · FMZ
Dragerwerk AG & CO Kgaa
General Hospital · 134d
Cleared Feb 22, 2019
Empower RF Catheter
K183240 · GEI
Broncus Medical, Inc.
General & Plastic Surgery · 94d
Cleared Feb 22, 2019
Libertas Acetabular Hooded Liner
K183365 · LZO
Maxx Orthopedics, Inc.
Orthopedic · 80d
Cleared Feb 22, 2019
Choice Spine Hawkeye Vertebral Body Replacement (VBR) System
K183588 · MQP
Choicespine
Orthopedic · 63d
Cleared Feb 22, 2019
EMMA 1.5T MRI System
K183621 · LNH
Time Medical Limited
Radiology · 58d
Cleared Feb 22, 2019
Cellvizio 100 Series Confocal laser Imaging systems and their Confocal...
K183640 · OWN
Mauna Kea Technologies
General & Plastic Surgery · 58d
Cleared Feb 22, 2019
Doctor Tecar
K183693 · PBX
Mectronic Medicale S.R.L.
General & Plastic Surgery · 53d
Cleared Feb 21, 2019
NobelParallel Conical Connection
K173418 · DZE
Nobel Biocare AB
Dental · 477d
Cleared Feb 21, 2019
Devon 62 Deep Vein Thrombosis (DVT) Prevention Therapy Device
K182578 · JOW
Devon Medical Products (Jiangsu), Ltd.
Cardiovascular · 155d
Cleared Feb 21, 2019
Sensus IORT System
K182641 · JAD
Sensus Healthcare, Inc.
Radiology · 150d
Cleared Feb 21, 2019
Sensus TPS Workstation
K182665 · MUJ
Sensus Healthcare, Inc.
Radiology · 149d
Cleared Feb 21, 2019
Coag-Sense Prothrombin Time (PT) / INR Monitoring Device
K183255 · GJS
Coagusense, Inc.
Hematology · 92d