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
34897–34920 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 04, 2015
NxStage System One
K150472 · ODN
Nxstage Medical, Inc.
Gastroenterology & Urology · 101d
Cleared Jun 04, 2015
ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMS
K150552 · NKG
Globus Medical, Inc.
Orthopedic · 92d
Cleared Jun 04, 2015
Tritium Sternal Cable Plate System
K150581 · JDQ
Pioneer Surgical Technology, Inc....
Orthopedic · 87d
Cleared Jun 04, 2015
Sure Lok Mini Posterior Cervical/Upper Thoracic System
K150851 · KWP
Precision Spine, Inc.
Orthopedic · 65d
Cleared Jun 04, 2015
Collage
K150976 · LLZ
Anatomage, Inc.
Radiology · 52d
Cleared Jun 04, 2015
AssureTech Secobarbital Strip, AssureTech Oxycodone Strip, AssureTech...
K151211 · DIS
Assure Tech. Co., Ltd.
Toxicology · 29d
Cleared Jun 03, 2015
SPB SKIN EMULSION
K141637 · FRO
Biotd S.A.
General & Plastic Surgery · 349d
Cleared Jun 03, 2015
DISPOSABLE PRE-GELLED SURFACE ELECTRODE
K142159 · GXY
Rochester Electro Medical, Inc.
Neurology · 301d
Cleared Jun 03, 2015
AOS Clavicle Intramedullary Device
K143204 · HSB
Advanced Orthopaedic Solutions, Inc.
Orthopedic · 208d
Cleared Jun 03, 2015
GE333 Blood Glucose Monitoring System
K143387 · NBW
Bionime Coporation
Chemistry · 189d
Cleared Jun 03, 2015
Cardio-TriTest
K143432 · DPS
Cardio-Phoenix, Inc.
Cardiovascular · 184d
Cleared Jun 03, 2015
Pulse Oximeter, Models PC-66A
K150093 · DQA
Shenzhen Creative Industry Co., Ltd.
Anesthesiology · 138d
Cleared Jun 03, 2015
ANAX OCT Spinal System
K150570 · NKG
U&I Corporation
Orthopedic · 89d
Cleared Jun 03, 2015
ACCU-CHEK Connect Diabetes Management App
K150910 · NDC
Roche Diabetes Care, Inc.
General Hospital · 61d
Cleared Jun 03, 2015
FibroScan
K150949 · IYO
Echosens
Radiology · 56d
Cleared Jun 03, 2015
MR Core Software
K151115 · LLZ
Vital Images, Inc.
Radiology · 37d
Cleared Jun 03, 2015
Mercury Spinal System
K151215 · NKB
Spinal Elements, Inc.
Orthopedic · 28d
Cleared Jun 02, 2015
MICRODENT GENIUS IMPLANT SYSTEM
K141188 · DZE
Implant Microdent
Dental · 390d
Cleared Jun 02, 2015
Everyway Facial MENS
K142794 · NFO
Everyway Medical Instruments Co.,Ltd
Neurology · 246d
Cleared Jun 02, 2015
Fiber Disks and Blocks (TRINIA)
K143524 · EBF
Bicon, LLC
Dental · 172d
Cleared Jun 02, 2015
PleuraFlow System
K150042 · OTK
Clearflow, Inc.
General & Plastic Surgery · 144d
Cleared Jun 02, 2015
Sonic Surgeon 310L, Sonic Surgeon 600L and Sonic Surgeon 800L
K150076 · DZI
Dong IL Technology , Ltd.
Dental · 139d
Cleared Jun 02, 2015
Injection Needle
K150434 · FBK
Micro-Tech (Nanjing) Co., Ltd.
Gastroenterology & Urology · 103d
Cleared Jun 02, 2015
Safe'n'Sound Staked Passive Delivery System - Plajex version
K150562 · MEG
Nemera
General Hospital · 88d