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
40273–40296 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 13, 2013
TANYX
K123866 · NUH
Medecell Us, Inc.
Neurology · 270d
Cleared Sep 13, 2013
PHYSICAL MONITORING REGISTRATION UNIT-S (PMRU-S)
K123902 · IKN
Oktx, LLC
Neurology · 269d
Cleared Sep 13, 2013
LOBSTER AUTO-INJECTOR
K124026 · KZH
Scandinavian Health Limited
General Hospital · 259d
Cleared CT Sep 13, 2013
DA VINCI FLUORESCENCE IMAGING VISION SYSTEM
K124031 · OWN
Intuitive Surgical, Inc.
General & Plastic Surgery · 259d
Cleared Sep 13, 2013
LOGIC STAND-ALONE INTERVERTEBRAL BODY FUSION DEVICE
K130641 · OVD
Binder Biomedical, Inc.
Orthopedic · 186d
Cleared CT Sep 13, 2013
VWING VASCULAR NEEDLE GUIDE, 4MM X 07MM
K130873 · PFH
Vital Access
Gastroenterology & Urology · 168d
Cleared Sep 13, 2013
PIONEER ELITE DIODE LASER
K131059 · GEX
CAO Group, Inc.
General & Plastic Surgery · 150d
Cleared Sep 13, 2013
SASMAR ORIGINAL, SASMAR CLASSIC
K131084 · NUC
Sasmar, Inc.
Obstetrics & Gynecology · 148d
Cleared Sep 13, 2013
CAS PSI KNEE SYSTEM
K131409 · JWH
Orthosoft, Inc.
Orthopedic · 121d
Cleared Sep 13, 2013
VYSIS D7S486/CEP 7 FISH PROBE KIT
K131508 · PFG
Abbott Molecular, Inc.
Pathology · 112d
Cleared Sep 13, 2013
CEROX
K131854 · DPW
Or-Nim Medical , Ltd.
Cardiovascular · 84d
Cleared Sep 13, 2013
EDWARDS LIFESCIENCES INTRACLUDE INTRA-AORTIC CATHETER
K132175 · DXC
Edwards Lifesciences, LLC
Cardiovascular · 60d
Cleared Sep 13, 2013
ADVIA CENTAUR FT4, ADVIA CENTAUR T4
K132249 · CEC
Siemens Healthcare Diagnostics, Inc.
Chemistry · 56d
Cleared Sep 13, 2013
VITEK 2 AST ST MOXIFLOXACIN, VITEK 2 AST STREPTOCOCCUS MOXIFLOXACIN
K132573 · LON
bioMerieux, Inc.
Microbiology · 28d
Cleared Sep 13, 2013
INTERLOCK - 18 FIBERED IDC OCCLUSION SYSTEM
K132578 · KRD
Boston Scientific Corp
Cardiovascular · 28d
Cleared Sep 12, 2013
SURGICAL GOWN (EO STERILIZED)
K112796 · FYA
Cobes Industries Co., Ltd.
General Hospital · 717d
Cleared Sep 12, 2013
JUNG RIM SINGLE USE HYPODERMIC SYRINGE WITH NEEDLE
K124037 · FMF
Jung Rim Medical Industrial Co., Ltd.
General Hospital · 258d
Cleared Sep 12, 2013
AUDIFON SUENO CIC, AUDIFON SUENO S, AUDIFON SUENO T CIC, AUDIFON SUENO T S
K130417 · KLW
Audifon-USA, Inc.
Ear, Nose, Throat · 205d
Cleared Sep 12, 2013
UNIVERSAL PASTE STAINS AND GLAZE
K130604 · EIH
Prismatik Dentalcraft, Inc.
Dental · 189d
Cleared Sep 12, 2013
VIVORTE BVF
K130703 · MBP
Vivorte, Inc.
Orthopedic · 181d
Cleared Sep 12, 2013
AUTOMATIC BLOOD PRESSURE MONITOR
K130925 · DXN
Honsun (Nantong) Co., Ltd.
Cardiovascular · 162d
Cleared Sep 12, 2013
IPROPHY MOBILE
K131578 · EKX
Nakanishi, Inc.
Dental · 104d
Cleared Sep 12, 2013
EXPEDIUM, VIPER. VIPER 2 SPINE SYSTEM
K131802 · OSH
Depuy Spine, A Johnson & Johnson Company
Orthopedic · 85d
Cleared Sep 12, 2013
MULTISTIM
K132137 · IPF
Metron Medical Australia, Pty, Ltd.
Physical Medicine · 63d