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
34177–34200 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 28, 2015
Eko Electronic Stethoscope System
K151319 · DQD
Eko Devices, Inc.
Cardiovascular · 102d
Cleared Aug 28, 2015
Arthrex Fracture Plates
K151732 · HRS
Arthrex, Inc.
Orthopedic · 63d
Cleared Aug 28, 2015
Menicon Saline Rinse Solution
K151768 · LPN
Menicon Co, Ltd.
Ophthalmic · 59d
Cleared Aug 28, 2015
IcePearl 2.1 CX Cryoablation Needle, IcePearl 2.1 CX Prostate Cryoablation...
K152133 · GEH
Galil Medical , Ltd.
General & Plastic Surgery · 28d
Cleared Aug 28, 2015
S8 Exp/S9 Pro Portable Digital Color Doppler Ultrasound System
K152164 · IYN
Sonoscape Medical Corp.
Radiology · 25d
Cleared Aug 27, 2015
Pruitt F3-S Carotid Shunt
K143454 · MJN
LeMaitre Vascular, Inc.
Cardiovascular · 267d
Cleared Aug 27, 2015
PRCT2
K143721 · HRS
Fx Solutions
Orthopedic · 241d
Cleared Aug 27, 2015
COOK Sydney IVF Blastocyst Vitrification Kit, COOK Sydney IVF Blastocyst...
K143724 · MQL
William A. Cook Australia Pty. , Ltd.
Obstetrics & Gynecology · 241d
Cleared Aug 27, 2015
DSS Sinusplasty Balloon Catheter
K143738 · LRC
Intuit Medical Products, LLC
Ear, Nose, Throat · 240d
Cleared Aug 27, 2015
Implanova
K150040 · DZE
Dental Evolutions, Inc.
Dental · 230d
Cleared Aug 27, 2015
CARDIOLINE HD+
K150289 · DRG
Cardioline S.P.A
Cardiovascular · 203d
Cleared Aug 27, 2015
Reprocessed Electrophysiology Diagnostic Catheters
K150357 · NLH
Sterilmed, Inc.
Cardiovascular · 196d
Cleared Aug 27, 2015
Respire Pink Series-Herbst-EF
K150572 · LRK
Respire Medical Holding
Dental · 174d
Cleared Aug 27, 2015
RxG Distraction System
K150771 · PBJ
KLS-Martin L.P.
Neurology · 156d
Cleared Aug 27, 2015
Rezum System
K150786 · KNS
Nxthera, Inc.
Gastroenterology & Urology · 155d
Cleared Aug 27, 2015
SenSmart Model 8203CA Regional Oximetry Sensor (Adult/Pediatric, >40 kg,...
K151305 · MUD
Nonin Medical, Inc.
Cardiovascular · 101d
Cleared Aug 27, 2015
Advanced Perfusion System 1
K151349 · DTQ
Terumo Cardiovascular Systems...
Cardiovascular · 99d
Cleared Aug 27, 2015
ProLite Mesh, ProLite Ultra Mesh, ProLoop Mesh Plug
K151437 · FTL
Atrium Medical Corporation
General & Plastic Surgery · 90d
Cleared Aug 27, 2015
JAZZ System
K151740 · OWI
Implanet, S.A.
Orthopedic · 62d
Cleared Aug 27, 2015
16 ch Tx/Rx Knee SPEEDER
K151753 · MOS
Quality Electrodynamics, LLC
Radiology · 59d
Cleared Aug 27, 2015
5.5 F Worley Advanced LVI Lateral Vein Introducer
K152116 · DYB
Merit Medical Systems, Inc.
Cardiovascular · 28d
Cleared Aug 26, 2015
UltraTENS
K142976 · IMI
Shenzhen Dongdixin Technology Co., Ltd.
Physical Medicine · 316d
Cleared Aug 26, 2015
AveCure Microwave Coagulation-Ablation Generator, AveCure Microwave Large...
K143203 · NEY
Medwaves Incorporated
General & Plastic Surgery · 292d
Cleared Aug 26, 2015
ActiSpec Activity Monitor
K143512 · ISD
Sleep Modus, Inc.
Physical Medicine · 258d