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
31585–31608 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 21, 2016
MectaLIF Anterior Stand-Alone
K160605 · OVD
Medacta International
Orthopedic · 141d
Cleared Jul 21, 2016
Tritanium® PL Cage
K160955 · MAX
Stryker
Orthopedic · 107d
Cleared Jul 21, 2016
EVEREST Spinal System
K161369 · NKB
K2m, Incorporated
Orthopedic · 65d
Cleared Jul 21, 2016
Genesys Spine Apache® Lateral Lumbar Interbody Fusion System
K161404 · MAX
Genesys Spine
Orthopedic · 62d
Cleared Jul 20, 2016
EVOTECH ECR
K152189 · FEB
Advanced Sterilization Products (Asp)
General Hospital · 350d
Cleared Jul 20, 2016
PRODIGY ASTRO Blood Glucose Monitoring System, PRODIGY ASTRO PRO Blood...
K152599 · NBW
Ok Biotech Co., Ltd.
Chemistry · 313d
Cleared Jul 20, 2016
XP1100 RF
K152731 · GEI
BTL Industries, Inc.
General & Plastic Surgery · 302d
Cleared Jul 20, 2016
ARC InstaTemp Non-Touch Thermometer, ARC InstaTemp MD Non-Touch Thermometer
K152905 · FLL
Arc Devices Limited
General Hospital · 293d
Cleared Jul 20, 2016
NR Line Implant System
K153268 · DZE
Dentium Co., Ltd.
Dental · 251d
Cleared Jul 20, 2016
SUNCO Mechanical Wheelchair, model SKW-9003
K153328 · IOR
Danyang Sunco Machinery Co., Ltd.
Physical Medicine · 244d
Cleared Jul 20, 2016
Operio
K153498 · ORC
Toul Meditech AB
General Hospital · 226d
Cleared Jul 20, 2016
Medline ReNewal Reprocessed LigaSure Blunt Tip Open Sealer/Divider
K160333 · NUJ
Surgical Instrument Service and...
General & Plastic Surgery · 163d
Cleared Jul 20, 2016
MultiScan G-Arm System
K160984 · OXO
Beijing East Whale Imaging Technology...
Radiology · 104d
Cleared Jul 20, 2016
OsteoFab Patient Specific Facial Device
K161052 · KKY
Oxford Performance Materials, Inc.
General & Plastic Surgery · 97d
Cleared Jul 20, 2016
Dextera MicroCutter 5/80 Blue Reload, Dextera MicroCutter 5/80 Blue Curved...
K161137 · GDW
Cardica, Inc.
General & Plastic Surgery · 89d
Cleared Jul 20, 2016
St. Louis Band
K161138 · OAN
Orthomerica Products, Inc.
Neurology · 89d
Cleared Jul 20, 2016
VITEK 2 AST-GN Cefepime (<=0.12->=32 ug/mL)
K161227 · LON
bioMerieux, Inc.
Microbiology · 79d
Cleared Jul 19, 2016
ABPM 7100, Hypertension Management Software
K153557 · DXN
I.E.M. GmbH
Cardiovascular · 218d
Cleared Jul 19, 2016
INTRAFIX(TM) Advance Tibial Fastener System
K160804 · MAI
Medos International SARL
Orthopedic · 118d
Cleared Jul 19, 2016
DePuy Actis DuoFix Hip Prosthesis
K160907 · MEH
Depuy(Ireland)
Orthopedic · 109d
Cleared Jul 19, 2016
Origin Coxa Vara Hip Stem
K161155 · MEH
Signature Orthopaedics Pty, Ltd.
Orthopedic · 85d
Cleared Jul 19, 2016
6400 Ultrasound System,7400 Ultrasound System, 7410 Ultrasound System
K161359 · IYN
Esaote, S.P.A.
Radiology · 64d
Cleared Jul 19, 2016
Ekso™ (version 1.1) and Ekso GT™ (version 1.2)
K161443 · PHL
Ekso Bionics, Inc.
Neurology · 55d
Cleared Jul 19, 2016
EnCor MRI Introducer Set, EnCor Probe Introducer
K161805 · KNW
Senorx, Inc.
Gastroenterology & Urology · 18d