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
33817–33840 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 14, 2015
Autosure Voice II Blood Glucose Monitoring System, Autosure Voice II Pro...
K150396 · NBW
Apex BioTechnology Corp.
Chemistry · 238d
Cleared Oct 14, 2015
Megasorb, Mitsu, Mitsu FST, Filaxyn, Filapron
K150717 · GAM
M/s. Meril Endo Surgery Private Limited.
General & Plastic Surgery · 209d
Cleared Oct 14, 2015
Talos Intervertebral Body Fusion Devices, Talos -C Cervical Intervertebral...
K150788 · ODP
Meditech Spine, LLC
Orthopedic · 203d
Cleared Oct 14, 2015
Dunamis Interference Screw
K151220 · MBI
Dunamis, LLC
Orthopedic · 160d
Cleared Oct 14, 2015
Mini Needle
K151571 · FMI
Ocujet, LLC
General Hospital · 126d
Cleared Oct 14, 2015
AngioDynamics Mariner Angiographic Catheters
K151724 · DQO
AngioDynamics, Inc.
Cardiovascular · 110d
Cleared Oct 14, 2015
Px HA PEEK IBF System
K151785 · MAX
Innovasis, Inc.
Orthopedic · 105d
Cleared CT Oct 14, 2015
Pantheris System
K152275 · MCW
Avinger, Inc.
Cardiovascular · 63d
Cleared Oct 14, 2015
OSS/Arcos IM Total Femur Rod
K152621 · JDI
Biomet, Inc.
Orthopedic · 30d
Cleared Oct 14, 2015
truFreeze System
K152668 · GEH
CSA Medical, Inc.
General & Plastic Surgery · 27d
Cleared Oct 13, 2015
Joinsoon EON L Glucose Monitoring System and Joinsoon EON LS Glucose...
K140325 · NBW
Joinsoon Medical Technology Co, Ltd.
Chemistry · 610d
Cleared Oct 13, 2015
GelPOINT Transvaginal Access Platform
K143308 · HEW
Applied Medical Resources
Obstetrics & Gynecology · 329d
Cleared Oct 13, 2015
DripAssist
K150687 · FLN
Shift Labs
General Hospital · 210d
Cleared Oct 13, 2015
PHIN-FX Cannulated Lag Screw System
K150693 · HWC
Ascent Medical, LLC
Orthopedic · 209d
Cleared Oct 13, 2015
HD-Camera HDC1000
K152109 · FET
W.O.M. World of Medicine GmbH
Gastroenterology & Urology · 76d
Cleared Oct 13, 2015
Boa Endoscopic Valve
K152140 · OCX
C2 Therapeutics, Inc.
Gastroenterology & Urology · 71d
Cleared Oct 13, 2015
Sensor Medical Single Use Tonometer Prism
K152308 · HKY
Sensor Medical Technology, LLC
Ophthalmic · 60d
Cleared Oct 13, 2015
BD BBL Sensi-Disc Ceftazidime Avibactam (30/20ug), Antimicrobial...
K152516 · JTN
Becton, Dickinson and Company
Microbiology · 40d
Cleared Oct 12, 2015
XW-100 Automated Hematology Analyzer, XW QC CHECK
K143577 · GKZ
Sysmex America, Inc.
Hematology · 299d
Cleared Oct 10, 2015
D2RS_AT Digital Dynamic Remote System
K150306 · JAA
Stephanix Radiological Solutions
Radiology · 243d
Cleared Oct 10, 2015
Vitrea CT Lung Density Analysis Software
K151919 · JAK
Vital Images, Inc.
Radiology · 89d
Cleared Oct 09, 2015
eCligner
K143499 · NXC
Eclear International Co., Ltd.
Dental · 303d
Cleared Oct 09, 2015
DRI Hydrocodone Assay, DRI Hydrocodone Calibrators, DRI Hydrocodone Controls
K150502 · DJG
Microgenics Corporation
Chemistry · 225d
Cleared Oct 09, 2015
CLICKLINE Scissor Insert for Single Use
K151044 · GEI
KARL STORZ Endoscopy-America, Inc.
General & Plastic Surgery · 172d