FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
39241–39264 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 06, 2013
BELMONT HYPERTHERMIA PUMP
K131519 · LGZ
Belmont Instrument Corp.
General Hospital · 162d
Cleared Nov 06, 2013
LEMAITRE 8F OCCLUSION CATHETER
K132022 · MJN
LeMaitre Vascular, Inc.
Cardiovascular · 128d
Cleared Nov 06, 2013
BARRIER EASYWARM ACTIVE SELF-WARMING BLANKET
K132048 · DWJ
Molnlycke Health Care Us, LLC
Cardiovascular · 127d
Cleared Nov 05, 2013
PREFERRED BLOOD GLUCOSE MONITORING SYSTEM
K122338 · NBW
Prodigy Diabetes Care, LLC
Chemistry · 460d
Cleared Nov 05, 2013
CARDIOX FLOW DETECTION SYSTEM
K122400 · DXG
Cardiox Corp.
Cardiovascular · 455d
Cleared Nov 05, 2013
DICOMPACS DX-R WITH FLAT PANEL
K131211 · MQB
Oehm Und Rehbein GmbH
Radiology · 190d
Cleared Nov 05, 2013
INFUSION SYRINGE SET
K131661 · FMF
Innovative Medical Manufacturing Co.
General Hospital · 151d
Cleared Nov 05, 2013
LEMILLS VALVULOTOME
K132047 · MGZ
LeMaitre Vascular, Inc.
Cardiovascular · 126d
Cleared Nov 05, 2013
GRYPHON BR ANCHOR W/ PROKNOT TECHNOLOGY, GRYPHON BR ANCHOR W/ PROKNOT...
K132241 · MAI
Depuy Mitek, A Johnson & Johnson Company
Orthopedic · 110d
Cleared Nov 05, 2013
EM SINUS DILATION SYSTEM
K132297 · LRC
Medtronic Xomed, Inc.
Ear, Nose, Throat · 104d
Cleared Nov 05, 2013
VIDA LED SURGICAL LIGHTING SYSTEM
K132307 · FSY
Convida Healthcare & Systems Corporation
General & Plastic Surgery · 104d
Cleared Nov 05, 2013
NURO NEUROMODULATION SYSTEM
K132561 · NAM
Advanced Uro-Solutions, Inc.
Gastroenterology & Urology · 82d
Cleared Nov 05, 2013
ARGYLE PERIPHERALLY INSERTED CENTRAL CATHETER SINGLE LUMEN, ARGYLE...
K132567 · LJS
Covidien
General Hospital · 82d
Cleared Nov 04, 2013
MECTACER BIOLOX OPTION HEADS
K131518 · LZO
Medacta International
Orthopedic · 160d
Cleared Nov 04, 2013
ARIX HAND SYSTEM
K131566 · HRS
Jeil Medical Corporation
Orthopedic · 158d
Cleared Nov 04, 2013
LIGHTHOUSE(TM) URINARY CATHETER
K131655 · EZL
Seedings Life Science Ventures, LLC
Gastroenterology & Urology · 151d
Cleared Nov 04, 2013
SENSATION SHORT THROW, CAPTIFLEX, CAPTIVATOR, CAPTIVATOR II, PROFILE,...
K131700 · FDI
Boston Scientific Corp
Gastroenterology & Urology · 146d
Cleared Nov 04, 2013
WOLF LONG BONE PLATE SYSTEM
K131834 · HRS
Toby Orthopaedics
Orthopedic · 137d
Cleared Nov 04, 2013
X-PORTE ULTRASOUND SYSTEM
K133134 · IYN
FUJIFILM Sonosite, Inc.
Radiology · 34d
Cleared Nov 01, 2013
CLEARPATH ALIGNER
K123514 · NXC
Qserve America, Inc.
Dental · 352d
Cleared Nov 01, 2013
SCANNING LASERLINK
K130195 · HQF
Lumenis, Inc.
Ophthalmic · 277d
Cleared Nov 01, 2013
SILK ROAD ACCESS CATHETER
K130649 · DQY
Silk Road Medical, Inc.
Cardiovascular · 235d
Cleared Nov 01, 2013
AMBU ASCOPE 3 5.0/2.2
K130845 · EOQ
Ambu A/S
Ear, Nose, Throat · 220d
Cleared Nov 01, 2013
PETITE BASIC SYSTEM 701 ELT
K131420 · JOW
Mego Afek AC , Ltd.
Cardiovascular · 169d