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
36073–36096 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 15, 2015
Pre-vacuum Tabletop Autoclave
K143311 · FLE
Tuttnauer U.S.A Co, Ltd.
General Hospital · 58d
Cleared Jan 15, 2015
ChoICE Guide Wire, Mailman Guide Wire, Luge Guide Wire, ChoICE PT Guide Wire,...
K143587 · DQX
Boston Scientific Corporation
Cardiovascular · 28d
Cleared Jan 15, 2015
truFreeze System
K143625 · GEH
CSA Medical, Inc.
General & Plastic Surgery · 24d
Cleared Jan 14, 2015
RapidVac Smoke Evacuator System
K142335 · FYD
Covidien
General Hospital · 146d
Cleared Jan 14, 2015
NOBLUS DIAGNOSTIC ULTRASOUND SCANNER
K142368 · IYN
Hitachi Aloka Medical, Ltd.
Radiology · 142d
Cleared Jan 14, 2015
UNIEVER Disposable Epidural Anesthesia Needle, UNIEVER Disposable Nerve...
K142553 · BSP
Unisis Corp.
Anesthesiology · 126d
Cleared Jan 14, 2015
AbbVie NJ
K142792 · KNT
AbbVie, Inc.
Gastroenterology & Urology · 110d
Cleared Jan 14, 2015
AbbVie PEG
K142793 · KNT
AbbVie, Inc.
Gastroenterology & Urology · 110d
Cleared Jan 14, 2015
AbbVie J
K142816 · KNT
AbbVie, Inc.
Gastroenterology & Urology · 107d
Cleared Jan 14, 2015
Medical Monofilament Sensory Screening Toool
K143068 · GXB
Medical Monofilament Manufacturing
Neurology · 82d
Cleared Jan 14, 2015
ADROIT Guiding Catheter
K143412 · DQY
Cordis Corporation
Cardiovascular · 47d
Cleared Jan 14, 2015
SignosRT Bladder Ultrasound System
K143493 · IYO
Signostics, Ltd.
Radiology · 36d
Cleared Jan 14, 2015
IMMULITE 2000 Albumin Calibration Verification Material, IMMULITE 2000...
K143504 · JJX
Siemens Healthcare Diagnostics, Inc.
Chemistry · 35d
Cleared Jan 14, 2015
Vivorte Trabexus EB
K143547 · MBP
Vivorte, Inc.
Orthopedic · 30d
Cleared Jan 14, 2015
Vivorte Trabexus
K143549 · MQV
Vivorte, Inc.
Orthopedic · 30d
Cleared Jan 13, 2015
EXTERNAL PULSE OXIMETER
K141024 · DQA
Beijing Choice Electronic Technololgy...
Anesthesiology · 267d
Cleared Jan 13, 2015
INFIX CANNULATED SCREW SYSTEM
K142057 · HWC
Infix Medical, LLC
Orthopedic · 168d
Cleared Jan 13, 2015
3B Laser 500, 3B Laser 200, LA-X P 500, LA-X P 200
K142722 · ILY
Livetec GmbH
Physical Medicine · 112d
Cleared Jan 13, 2015
PK Cutting Forceps for ESG-400 Workstation
K142759 · GEI
Gyrus Acmi, Inc.
General & Plastic Surgery · 110d
Cleared Jan 13, 2015
Revolution Spinal Fixation System
K142939 · NKB
Intelligent Implant Systems, LLC
Orthopedic · 96d
Cleared Jan 13, 2015
BIOSURE REGENESORB interference Screw
K142948 · MAI
Smith & Nephew, Inc.
Orthopedic · 95d
Cleared Jan 13, 2015
InMode Diolaze Device
K142952 · GEX
Inmode MD , Ltd.
General & Plastic Surgery · 95d
Cleared Jan 13, 2015
Triathlon Tritanium Cone Augments
K143393 · MBH
Stryker Orthopaedics
Orthopedic · 48d
Cleared Jan 13, 2015
CR3 Keyless Split Sample Cup Secobarbital- Methadone
K143535 · DIS
Guangzhou Wondfo Biotech Co., Ltd.
Chemistry · 29d