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
31201–31224 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 05, 2016
SyncVision System
K161756 · OWB
Volcano Corporation
Radiology · 70d
Cleared Sep 03, 2016
CardioConfirm
K161465 · DQK
Mortara Instrument, Inc.
Cardiovascular · 99d
Cleared Sep 02, 2016
JET SET 4 DENTURE REPAIR RESIN
K152981 · EBI
Lang Dental Manufacturing Company, Inc.
Dental · 329d
Cleared Sep 02, 2016
PROcedure Rehearsal Studio
K153705 · LLZ
3Dsystems, Simbionix Products
Radiology · 254d
Cleared Sep 02, 2016
Nihon Kohden Vital Sign Telemeter
K153707 · MHX
Nihon Kohden Corporation
Cardiovascular · 254d
Cleared Sep 02, 2016
Pro-Link® Stand-Alone Cervical Spacer System
K160066 · OVE
Life Spine, Inc.
Orthopedic · 233d
Cleared Sep 02, 2016
Perineologic Access Needle
K160423 · FCG
Corbin Clinical Resources, LLC
Gastroenterology & Urology · 199d
Cleared Sep 02, 2016
WiCap
K160582 · DQA
Athena Gtx
Anesthesiology · 185d
Cleared Sep 02, 2016
Indy OTW Vascular Retriever
K160593 · MMX
Cook Incorporated
Cardiovascular · 185d
Cleared Sep 02, 2016
LigaPASS
K160698 · OWI
Medicrea International SA
Orthopedic · 172d
Cleared Sep 02, 2016
MyLabSix Ultrasound System
K161168 · IYN
Esaote Europe B.V.
Radiology · 129d
Cleared Sep 02, 2016
Sysmex Automated Blood Coagulation Analyzer CS-5100
K161317 · JPA
Siemens Healthcare Diagnostics...
Hematology · 114d
Cleared Sep 02, 2016
Tangis Anterior Cervical Plate
K161524 · KWQ
Nvision Biomedical Technologies, LLC
Orthopedic · 92d
Cleared Sep 02, 2016
FilmArray RP EZ Control Panel M265
K161573 · PMN
Maine Molecular Quality Controls, Inc.
Microbiology · 87d
Cleared Sep 02, 2016
Arctic Sun Temperature Management System
K161602 · DWJ
Medivance, Inc.
Cardiovascular · 85d
Cleared Sep 02, 2016
MAGEC® Spinal Bracing and Distraction System
K161751 · PGN
Nuvasive Specialized Orthopedics, Inc.
Orthopedic · 70d
Cleared Sep 02, 2016
Restore PACS
K162141 · LLZ
Xian Wingspan Electronic Technology...
Radiology · 32d
Cleared Sep 02, 2016
Edwards eSheath Introducer Set
K162184 · DYB
Edward Lifesciences
Cardiovascular · 29d
Cleared Sep 01, 2016
IBL 5000 Tanning Booth
K152405 · LEJ
Ibl Acquisitions, LLC
General & Plastic Surgery · 373d
Cleared Sep 01, 2016
Cathtong I PICC Catheter
K153469 · LJS
L&Z Us, Inc.
General Hospital · 275d
Cleared Sep 01, 2016
Concert Medical Hands-Free Syringe (HFS)
K153599 · FRN
Concert Medical, LLC
General Hospital · 260d
Cleared Sep 01, 2016
Hi bebe plus
K160274 · HGX
Bistos Co., Ltd.
Obstetrics & Gynecology · 212d
Cleared Sep 01, 2016
BC-5390 Auto Hematology Analyzer
K160429 · GKZ
Mindray Bio-Medical Electronics Co.,...
Hematology · 198d
Cleared Sep 01, 2016
Noiselezz
K160531 · LRK
Firma Ingemarsson
Dental · 189d