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
34777–34800 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 17, 2015
Matristem Surgery Matrix RS, PSM, PSMX, Matristem Pelvic Floor Matrix
K141084 · FTM
Acell, Inc.
General & Plastic Surgery · 415d
Cleared Jun 17, 2015
BELIMED STEAM STERILIZER MST-H
K141879 · FLE
Sauter AG
General Hospital · 341d
Cleared Jun 17, 2015
Urinary Incontinence System
K142369 · KPI
Guangzhou Finecure Medical Equipment...
Gastroenterology & Urology · 296d
Cleared Jun 17, 2015
ABL800 FLEX with AQURE connectivity
K142898 · CHL
Radiometer Medical Aps
Chemistry · 254d
Cleared Jun 17, 2015
CrossCountry Transbronchial Access Tool straight, CrossCountry Transbronchial...
K142934 · EOQ
Covidien
Ear, Nose, Throat · 251d
Cleared Jun 17, 2015
dynaMX Compression Staple
K143622 · JDR
Mx Orthopedics, Corp.
Orthopedic · 177d
Cleared Jun 17, 2015
VS3-IR-MMS System
K150018 · OWN
Visionsense, Ltd.
General & Plastic Surgery · 163d
Cleared Jun 17, 2015
PALACOS R pro
K150119 · LOD
Heraeus Medical GmbH
Orthopedic · 148d
Cleared Jun 17, 2015
Vdrive system, Vdrive Duo, Vdrive with V-Sono
K150312 · DXX
Stereotaxis, Inc.
Cardiovascular · 128d
Cleared Jun 17, 2015
STAR 90
K150512 · MWI
Skanray Technologies Pvt, Ltd.
Cardiovascular · 110d
Cleared Jun 17, 2015
True Dilatation Balloon Valvuloplasty Catheter
K150667 · OZT
C.R. Bard, Inc.
Cardiovascular · 93d
Cleared Jun 17, 2015
ProTrack RF Anchor Wire
K150709 · DXF
Baylis Medical Company, Inc.
Cardiovascular · 90d
Cleared Jun 17, 2015
ARDO Calypso Pro Powered Breast Pump
K150721 · HGX
Ardo Medical AG
Obstetrics & Gynecology · 90d
Cleared Jun 17, 2015
ESTECEM
K150727 · EMA
Tokuyama Dental Corporation
Dental · 89d
Cleared Jun 17, 2015
truFreeze System
K150920 · GEH
CSA Medical, Inc.
General & Plastic Surgery · 72d
Cleared Jun 17, 2015
NuVasive CoRoent Thoracolumbar Implants
K150994 · PHM
Nu Vasive, Incorporated
Orthopedic · 63d
Cleared Jun 17, 2015
AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip
K150996 · FZP
AtriCure, Inc.
General & Plastic Surgery · 63d
Cleared Jun 16, 2015
VEINOPLUS SPORT NEUROMUSCULAR STIMULATOR
K141919 · NGX
Ad Rem Technology Sarl
Physical Medicine · 336d
Cleared Jun 16, 2015
OsteoCool V-2 RF Ablation System
K142480 · GEI
Baylis Medical Company, Inc.
General & Plastic Surgery · 285d
Cleared Jun 16, 2015
Navigated Disc Prep Instruments and CAPSTONE Trials
K150231 · OLO
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 134d
Cleared Jun 16, 2015
Cavitron Touch Ultrasonic Scaling System
K150535 · ELC
Dentsply International, Inc.
Dental · 105d
Cleared Jun 16, 2015
OARtrac System with Skin Sensors
K150719 · NZT
Radiadyne, LLC
Radiology · 89d
Cleared Jun 16, 2015
Zimmer PSI Shoulder System
K150730 · KWT
Zimmer
Orthopedic · 88d
Cleared Jun 16, 2015
Edwards Suture Fastening System
K150882 · HCF
Edwards Lifesciences, LLC
General & Plastic Surgery · 75d