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
31177–31200 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 07, 2016
ELITech Clinical Systems GLUCOSE HK SL, ELITech Clinical Systems ELICAL 2,...
K153644 · CFR
Elitechgroup
Chemistry · 261d
Cleared Sep 07, 2016
CareSens Pen Needle, Softip Pen Needle
K160575 · FMI
Yidobio, Inc.
General Hospital · 190d
Cleared Sep 07, 2016
ADVIA Chemistry Creatine Kinase (CK_L) Assay, ADVIA Chemistry Enzyme 3...
K160724 · CGS
Siemens Healthcare Diagnostics, Inc.
Chemistry · 175d
Cleared Sep 07, 2016
Procellera
K160783 · FRO
Vomaris Innovations, Inc.
General & Plastic Surgery · 169d
Cleared Sep 07, 2016
Next Science Irrigation Solution
K161165 · FQH
Next Science, LLC
General & Plastic Surgery · 135d
Cleared Sep 07, 2016
Signia sterilization tray
K161347 · KCT
Covidien
General Hospital · 114d
Cleared Sep 07, 2016
Symmetry Sharp Kerrison Rongeur
K161744 · HAE
Symmetry Surgical, Inc.
Neurology · 75d
Cleared Sep 07, 2016
Weck Auto Endo10 Automatic Endoscopic Clip Applier
K161758 · FZP
Teleflex Medical
General & Plastic Surgery · 72d
Cleared Sep 07, 2016
GENflex2 Total Knee System
K162222 · JWH
Stelkast, Inc.
Orthopedic · 30d
Cleared Sep 06, 2016
3Shape Abutment Designer Software
K151455 · PNP
3Shape A/S
Dental · 463d
Cleared Sep 06, 2016
BD MAX CT/GC/TV, BD MAX INSTRUMENT
K151589 · OUY
Becton, Dickinson and Company
Microbiology · 452d
Cleared Sep 06, 2016
HAMILTON-MR1
K153046 · CBK
Hamilton Medical AG
Anesthesiology · 323d
Cleared Sep 06, 2016
Active-X Total Knee System
K160159 · JWH
Signature Orthopaedics Pty, Ltd.
Orthopedic · 223d
Cleared Sep 06, 2016
Surgical Face Masks (Ear loops and Tie-on)
K160269 · FXX
San-M Package Co., Ltd.
General Hospital · 217d
Cleared Sep 06, 2016
HALYARD* PURPLE NITRILE – XTRA* Powder-Free Exam Gloves
K160709 · LZC
Halyard Health
General Hospital · 176d
Cleared Sep 06, 2016
Nexus DRTM Digital X-ray Imaging System (with PaxScan 4336Wv4)
K161459 · MQB
Varian Medical Systems, X-Ray...
Radiology · 103d
Cleared Sep 06, 2016
Xenco Medical Posterior Cervical System
K161478 · NKG
Xenco Medical, LLC
Orthopedic · 98d
Cleared Sep 06, 2016
Nanovis Intervertebral Body Fusion System and Forticore(R)
K161485 · MAX
Nanovis, LLC
Orthopedic · 98d
Cleared Sep 06, 2016
Mano and Mano Personal Lubricant
K161585 · NUC
Mano and Mano Proprietary Limited
Obstetrics & Gynecology · 90d
Cleared Sep 06, 2016
Resection Electrodes
K161600 · JOS
Olympus Winter & Ibe GmbH
General & Plastic Surgery · 89d
Cleared Sep 06, 2016
CG+ Arrow JACC
K161765 · LJS
Arrow International, Inc. (Subsidiary...
General Hospital · 71d
Cleared Sep 06, 2016
ACUSON SC2000 Diagnostic Ultrasound System
K162221 · IYN
Siemens Medical Solutions Inc....
Radiology · 29d
Cleared Sep 06, 2016
ACUSON S1000 / S2000 / S3000 Diagnostic Ultrasound System
K162243 · IYN
Siemens Medi Cal Solutions, Inc.
Radiology · 27d
Cleared Sep 06, 2016
Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound...
K162267 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 26d