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.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
54457–54480 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 02, 2009
IPULSE, MODEL: I150
K083748 · GEX
Cyden Limited
General & Plastic Surgery · 47d
Cleared Feb 02, 2009
ATL CO2 MEDICAL LASER SYSTEMS, MODELS ATL-150 AND ATL-250
K083918 · GEX
Advanced Technology Laser Co., Ltd.
General & Plastic Surgery · 34d
Cleared Feb 02, 2009
BLOOD PRESSURE MONITOR, ZSBP-003/004/005/006/007/008 AND...
K090027 · DXN
Zen Strong Medical Technology Co., Ltd.
Cardiovascular · 28d
Cleared Feb 01, 2009
OLECRANAIL INTRAMEDULLARY FIXATION SYSTEM
K090091 · HSB
Mylad Orthopedic Solutions, LLC
Orthopedic · 18d
Cleared Jan 30, 2009
PATIENT ISOLATION UNIT, MODEL G019-1000
K080117 · LGM
Gentex Corporation
General Hospital · 379d
Cleared Jan 30, 2009
QLASER SYSTEM
K080513 · NHN
2035, Inc.
Physical Medicine · 340d
Cleared Jan 30, 2009
NITI-S ESOPHAGEAL STENT
K080782 · ESW
Taewoong Medical Co., Ltd.
Gastroenterology & Urology · 317d
Cleared Jan 30, 2009
NOVEL SPINAL SYSTEM
K081153 · MNH
Medyssey Co, Ltd.
Orthopedic · 282d
Cleared Jan 30, 2009
FORA TD-4251/U-RIGHT TD-4252/U-RIGHT TD-4254 BLOOD GLUCOSE MONITORING SYSTEM,...
K082482 · CGA
Taidoc Technology Corporation
Chemistry · 155d
Cleared Jan 30, 2009
REVOLUTIONFULL FACE MASK
K082866 · BZD
Respironics Inc., Sleep & Home...
Anesthesiology · 123d
Cleared Jan 30, 2009
S-TEST C-REACTIVE PROTEIN (CRP)
K083040 · DCN
Alfa Wassermann Diagnostic...
Chemistry · 108d
Cleared Jan 30, 2009
AIR SONIC SCALER
K083059 · ELC
Dpm USA Corp.
Dental · 108d
Cleared Jan 30, 2009
SMITH & NEPHEW PEEK INTERFERENCE SCREW
K083226 · MBI
Smith & Nephew Endoscopy, Inc.
Orthopedic · 88d
Cleared Jan 30, 2009
MEDILAS D FAMILY LASERS, INCLUDING MEDILAS D LITEBEAM, LITEBEAM +, UROBEAM,...
K083258 · GEX
Dornier Medtech America, Inc.
General & Plastic Surgery · 87d
Cleared Jan 30, 2009
ORTHOPEDIATRICS PEDILOC LOCKING PLATE SYSTEM
K083286 · HRS
OrthoPediatrics Corp.
Orthopedic · 86d
Cleared Jan 30, 2009
PREMIER CAMPY, MODEL 618096
K083464 · LQP
Meridian Bioscience, Inc.
Microbiology · 67d
Cleared Jan 30, 2009
CAMLOG IMPLANT SYSTEM MODIFIED IMPLANTS AND ABUTMENTS
K083496 · DZE
Altatec GmbH
Dental · 66d
Cleared Jan 30, 2009
SMITH & NEPHEW BIOSURE PK INTERFERENCE SCREW
K083635 · MBI
Smith & Nephew Endoscopy, Inc.
Orthopedic · 53d
Cleared Jan 30, 2009
POWDER FREE NITRILE EXAMINATION GLOVES, BUBBLE GUM SCENTED, PINK
K083717 · LZA
Gx Corporation Sdn Bhd
General Hospital · 46d
Cleared Jan 30, 2009
RETCAM PORTABLE OPHTHALMIC IMAGING SYSTEM, MODEL RCP
K083771 · HKI
Clarity Medical Systems
Ophthalmic · 43d
Cleared Jan 30, 2009
MARVEL PEDIATRIC WHEELCHAIR
K083847 · IOR
Rogue Wheelchairs, Inc.
Physical Medicine · 37d
Cleared Jan 30, 2009
MYLABFIVE
K083882 · IYN
Esaote Europe B.V.
Radiology · 32d
Cleared Jan 30, 2009
IF SERIES TRUE SINE INTERFERENTIAL STIMULATOR, MODEL: WL-2206B AND WL-2106E
K090023 · LIH
Well-Life Healthcare Limited
Neurology · 25d
Cleared Jan 30, 2009
ALL-IN-ONE CONTAINER
K090096 · KPE
Baxter Healthcare Corporation
General Hospital · 15d