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
33649–33672 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 02, 2015
PROBEAT-V
K152592 · LHN
Hitachi, Ltd., Health Care Company
Radiology · 53d
Cleared Nov 02, 2015
EGENS Urine Test Cup THC-MDMA, EGENS Urine Test DipCard THC-MDMA, EGENS Urine...
K152643 · LDJ
Nantong Egens Biotech Co., Ltd.
Toxicology · 48d
Cleared Nov 02, 2015
HS70A Diagnostic Ultrasound System
K152962 · IYN
Samsung Medison Co., Ltd.
Radiology · 26d
Cleared Oct 30, 2015
Elliquence Electrodes
K142410 · GEI
Elliquence, LLC
General & Plastic Surgery · 428d
Cleared Oct 30, 2015
SYMBIS Surgical System
K143420 · HAW
Imris, Inc.
Neurology · 336d
Cleared Oct 30, 2015
Start-Up Kit (SUK), Cool Line Intravascular Heat Exchange Catheter, ICY...
K150046 · NCX
Zoll Circulation, Inc.
Neurology · 291d
Cleared Oct 30, 2015
Vera
K150462 · LXJ
Reflexion Health, Inc.
Physical Medicine · 249d
Cleared Oct 30, 2015
SCENARIA Phase 3 Whole-body X-ray CT System
K150595 · JAK
Hitachi Medical Systems America, Inc.
Radiology · 235d
Cleared Oct 30, 2015
Lumenis Smart532 Laser System
K151109 · GEX
Lumenis, Inc.
General & Plastic Surgery · 186d
Cleared Oct 30, 2015
Lung Analysis Software
K151283 · JAK
Vital Images, Inc.
Radiology · 169d
Cleared Oct 30, 2015
Philips CS770 IntelliSpace Critical Care and Anesthesia
K151366 · DXJ
Philips Medical Systems
Cardiovascular · 162d
Cleared Oct 30, 2015
MasterLoc Stem
K151531 · LZO
Medacta International
Orthopedic · 144d
Cleared Oct 30, 2015
Prime&Bond Elect Universal Dental Adhesive
K151619 · KLE
Dentsply International, Inc.
Dental · 136d
Cleared Oct 30, 2015
Cardinal Health Sterilization Wrap
K151788 · FRG
Cardinal Health200, LLC
General Hospital · 121d
Cleared Oct 30, 2015
Acumed Ankle and Small Fragment Base Set Update
K151886 · HRS
Acumed, LLC
Orthopedic · 113d
Cleared Oct 30, 2015
Frontier Medical Devices In-line Orthopedic Cable Cerclage System
K151888 · JDQ
Frontier Medical Devices, Inc.
Orthopedic · 112d
Cleared Oct 30, 2015
X8 System - Sleep Profiler (SP40), X8 System - Sleep Profiler PSG2 (SP29), X8...
K152040 · OMC
Advanced Brain Monitoring, Inc.
Neurology · 100d
Cleared Oct 30, 2015
Cosmedico Ultraviolet Lamps of Various Models
K152273 · LEJ
Cosmedico Light, Inc.
General & Plastic Surgery · 79d
Cleared Oct 30, 2015
RECON system-V-TEK-IVP Plates and Screws
K152312 · HRS
Normed Medizin-Technik GmbH
Orthopedic · 74d
Cleared Oct 30, 2015
MicroSTAAR Injector System Cartridges
K152357 · KYB
STAAR Surgical Company
Ophthalmic · 71d
Cleared Oct 30, 2015
Prelude SNAP Splittable Hydrophilic Sheath Introducer
K152381 · DYB
Merit Medical Systems, Inc.
Cardiovascular · 67d
Cleared Oct 30, 2015
DURAFORM Dural Graft Implant
K152481 · GXQ
Codman & Shurtleff, Inc.
Neurology · 60d
Cleared Oct 30, 2015
Philips Lumify Diagnostic Ultrasound System
K152899 · IYN
Philips Healthcare, Inc.
Radiology · 29d
Cleared Oct 29, 2015
INSTRUMENT CASSETTE (EFCCL1-F)
K141854 · KCT
Osung Mnd Co., Ltd.
General Hospital · 477d