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
71065–71088 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 29, 2003
TRIVEX SYSTEM
K032387 · DWQ
Smith & Nephew, Inc.
Cardiovascular · 86d
Cleared Oct 29, 2003
GIVEN DIAGNOSTIC SYSTEM
K032405 · NEZ
Given Imaging , Ltd.
Gastroenterology & Urology · 86d
Cleared Oct 29, 2003
KLS-MARTIN MANDIBULAR/RECONSTRUCTION SYSTEM II
K032442 · MQN
KLS-Martin L.P.
Dental · 82d
Cleared Oct 29, 2003
MEDICAL LASER TECHNOLOGIES, LLC MTL ERBIUM:YAG LASER SYSTEM
K032599 · GEX
Medical Laser Technologies, LLC
General & Plastic Surgery · 65d
Cleared Oct 29, 2003
XTRAK SUPPORT CATHETER
K032660 · DQY
Xtrak Medical, Inc.
Cardiovascular · 62d
Cleared Oct 29, 2003
VITREA2, VERSION 3.4 MEDICAL IMAGE PROCESSING SOFTWARE
K032748 · LLZ
Vital Images, Inc.
Radiology · 54d
Cleared Oct 29, 2003
AC 3 LUMEN CENTRAL VENOUS ACCESS KIT WITH ARROWG+ARD ANTIMICROBIAL SURFACE
K032962 · FOZ
Arrow Intl., Inc.
General Hospital · 36d
Cleared Oct 29, 2003
SYNTHES 2.0 MM CRANIOFACIAL LOCKING PLATES
K033065 · MQN
Synthes (Usa)
Dental · 30d
Cleared Oct 29, 2003
DATEX OHMEDA S/5 WEB VIEWER AND S/5 POCKET VIEWER WITH L-WEB03 SOFTWARE
K033078 · MSX
Datex-Ohmeda
Cardiovascular · 30d
Cleared Oct 29, 2003
SECTRA IDS5 RADIOLOGY WORKSTATION VERSION 10.1
K033088 · LLZ
Sectra AB
Radiology · 30d
Cleared Oct 29, 2003
MONARCH 21 PENILE PLETHYSMOGRAPH SYSTEM
K033126 · LIL
Behavioral Technology, Inc.
Gastroenterology & Urology · 29d
Cleared Oct 29, 2003
NEUROMUSCULAR ELECTRICAL STIMULATOR, MODEL EV-807P
K033140 · IPF
Everyway Medical Instruments Co.,Ltd
Physical Medicine · 29d
Cleared Oct 29, 2003
ALOKA SSD-5000 V5.0 ULTRASOUND SYSTEM
K033311 · IYN
Aloka Co., Ltd.
Radiology · 15d
Cleared Oct 29, 2003
SUPEROPEN 0.23T, MODEL NAM-P023A
K033315 · LNH
Neusoft Digital Medical Systems Co.,...
Radiology · 14d
Cleared Oct 29, 2003
PHILIPS PLUS COMPUTED TOMOGRAPHY SYSTEM
K033326 · JAK
Philips Medical Systems, Inc.
Radiology · 13d
Cleared Oct 28, 2003
ORTRAUTEK ORTHOGNATHIC SYSTEM
K031989 · JEY
Tekka
Dental · 123d
Cleared Oct 28, 2003
NXSTAGE SYSTEM ONE WITH CARTRIDGE EXPRESS
K032356 · KDI
Nxstage Medical, Inc.
Gastroenterology & Urology · 90d
Cleared Oct 28, 2003
MEDTRONIC MINIMED PARADIGM COUNTACH INFUSION SET, MODEL MMT 310
K032484 · FPA
Medtronic Minimed
General Hospital · 77d
Cleared Oct 28, 2003
MEDTRONIC MINIMED COUNTACH INFUSION SET, MODEL 313
K032485 · FPA
Medtronic Minimed
General Hospital · 77d
Cleared Oct 28, 2003
KAVO EVEREST ZH-BLANK
K033221 · EIH
Kavo America Corporation
Dental · 25d
Cleared Oct 28, 2003
BUTLER NUCARE ROOT CONDITIONER WITH NOVAMIN
K033295 · LBH
Novamin Technology, Inc.
Dental · 14d
Cleared Oct 27, 2003
PERFADEX SOLUTION FOR LUNG PRESERVATION
K022730 · MSB
Vitrolife AB
Gastroenterology & Urology · 437d
Cleared Oct 27, 2003
EMBLA N7000
K024322 · MNR
Medcare Flaga
Anesthesiology · 305d
Cleared Oct 27, 2003
FLUID SAMPLE RETRIEVAL SYSTEM
K030394 · JKA
Biomed Personal Metabolic and...
Chemistry · 264d