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
33673–33696 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 29, 2015
Wire Sterilization Package with Indicators
K143117 · FRG
American Orthodontics
General Hospital · 364d
Cleared Oct 29, 2015
MOPYLEN, RESOPREN, SILK, POLYESTER, NYLON, RESOLON, POLYAMIDE PSEUDO, STEEL
K143582 · GAW
Resorba Medical GmbH
General & Plastic Surgery · 315d
Cleared Oct 29, 2015
DSM Biomedical DPR Cable
K143716 · JDQ
Dsm Biomedical
Orthopedic · 304d
Cleared Oct 29, 2015
PENTAX Medical EKP-i5010 Video Processor with EB Family
K143727 · EOQ
Pentax of America, Inc.
Ear, Nose, Throat · 304d
Cleared Oct 29, 2015
AVAmax Vertebral Balloon
K150523 · HRX
Care Fusion
Orthopedic · 241d
Cleared Oct 29, 2015
ARROW Humeral stems size 6 and 16
K150568 · PHX
Fournitures Hospitalieres Industrie
Orthopedic · 237d
Cleared Oct 29, 2015
Leksell Gamma Knife Perfexion
K151159 · IWB
Elekta Instrument AB
Radiology · 181d
Cleared Oct 29, 2015
Small Bone Nail Implant
K151456 · HSB
Vilex IN Tennessee, Inc.
Orthopedic · 150d
Cleared Oct 29, 2015
T3 Software
K151715 · MWI
Etiometry, Inc.
Cardiovascular · 126d
Cleared Oct 29, 2015
iFuse Implant System
K151718 · OUR
SI-BONE, Inc.
Orthopedic · 126d
Cleared Oct 29, 2015
ALAR Nasal Valve Stent
K151758 · GAT
Medtronic Xomed, Inc.
General & Plastic Surgery · 122d
Cleared Oct 29, 2015
Pavati Zirconia
K151875 · EIH
Ccri, Inc.
Dental · 112d
Cleared Oct 29, 2015
IPS Ivocolor
K151894 · EIH
Ivoclar Vivadent, AG
Dental · 111d
Cleared Oct 29, 2015
STERRAD CYCLESURE 24 Biological Indicator
K151971 · FRC
Advanced Sterilization Products
General Hospital · 105d
Cleared Oct 29, 2015
Physica PS Knee System
K152008 · JWH
Lima Corporate S.P.A.
Orthopedic · 100d
Cleared Oct 29, 2015
OPTIS Mobile System
K152120 · NQQ
Lightlab Imaging, Inc.
General & Plastic Surgery · 91d
Cleared Oct 29, 2015
FlexiCap Disconnect Cap with Povidone-Iodine Solution, MiniCap with...
K152129 · KDJ
Baxter Healthcare Corporation
Gastroenterology & Urology · 90d
Cleared Oct 29, 2015
Oravan Herbst
K152159 · LRK
Oravanosa, LLC
Dental · 87d
Cleared Oct 29, 2015
Optiflux dialyzer
K152367 · KDI
Fresenius Medical Care North America
Gastroenterology & Urology · 69d
Cleared Oct 29, 2015
Disposable Blood Pressure Cuff
K152465 · DXQ
Shenzhen Vistar Medical Supplies Co.,...
Cardiovascular · 59d
Cleared Oct 29, 2015
Reusable Blood Pressure Cuff
K152468 · DXQ
Shenzhen Vistar Medical Supplies Co.,...
Cardiovascular · 59d
Cleared Oct 29, 2015
Integra DigiFuse Cannulated Intramedullary Fusion System
K152527 · HWC
Ascension Orthopedics
Orthopedic · 56d
Cleared Oct 29, 2015
M9/M9CV/M9T Diagnostic Ultrasound System
K152543 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 55d
Cleared Oct 29, 2015
Impulse Angiographic Catheter, Expo Angiographic Catheter
K152605 · DQO
Boston Scientific Corporation
Cardiovascular · 48d