Search FDA 510(k) Database

7,163 clearances indexed · Search by device name, K-number, manufacturer or product code

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174,061 results
22849–22872 of 174,061
Cleared Oct 29, 2018
HSV 1 & 2 ELITe MGB Kit
K180559 · PGI
Elitechgroup
Microbiology · 242d
Cleared Oct 29, 2018
Infrared Forehead Thermometer, Infrared Ear/Forehead Thermometer
K181239 · FLL
Joytech Healthcare Co. , Ltd.
General Hospital · 172d
Cleared Oct 29, 2018
ClearLink Controlled Phototherapy Equipment
K182215 · FTC
Daavlin Distributing Company
General & Plastic Surgery · 75d
Cleared Oct 29, 2018
MC3 Vascular Access Kit 21030
K182914 · DRE
Mc3 Incorporated
Cardiovascular · 11d
Cleared Oct 27, 2018
ORTHROS™ Posterior Stabilization System
K180980 · NKB
Camber Spine Technologies, LLC
Orthopedic · 197d
Cleared Oct 27, 2018
Reprocessed Advisor FL Sensor Enabled Circular Mapping Catheter
K181458 · NLH
Innovative Health, LLC
Cardiovascular · 145d
Cleared Oct 26, 2018
Biomate Dental Implant System
K170732 · DZE
Biomate Medical Devices Technology...
Dental · 595d
Cleared Oct 26, 2018
Implant Planning Software
K173965 · LLZ
Inteware Co., Ltd.
Radiology · 301d
Cleared Oct 26, 2018
PENTAX Medical Video Colonoscope EC34-i10T Series
K180285 · FDF
Pentax Medical of America, Inc.
Gastroenterology & Urology · 267d
Cleared Oct 26, 2018
Polyethylene Catheter
K180286 · DQO
Cook Incorporated
Cardiovascular · 267d
Cleared Oct 26, 2018
Cook Silicone Balloon HSG Catheter
K180291 · LKF
Cook Incorporated
Obstetrics & Gynecology · 267d
Cleared Oct 26, 2018
Margolin HSG Cannula, Goldstein Sonohysterography Catheter
K180300 · LKF
Cook Incorporated
Obstetrics & Gynecology · 266d
Cleared Oct 26, 2018
Peak.me
K180487 · BZH
Breathe Me, Ltd.
Anesthesiology · 245d
Cleared Oct 26, 2018
TSI Transseptal Introducer
K181031 · DYB
Pressure Products Medical Device...
Cardiovascular · 191d
Cleared Oct 26, 2018
Invisalign System with Mandibular Advancement Feature
K181739 · NXC
Align Technology, Inc.
Dental · 116d
Cleared Oct 26, 2018
Two-Step Implant System
K181898 · HWC
Trilliant Surgical
Orthopedic · 102d
Cleared Oct 26, 2018
Dexcom G6 Glucose Program Continuous Glucose Monitoring System
K182041 · QDK
Dexcom, Inc.
Chemistry · 88d
Cleared Oct 26, 2018
Accipiolx
K182177 · QAS
Maxq-Al , Ltd.
Radiology · 77d
Cleared Oct 26, 2018
MAGNETOM Aera
K182299 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 63d
Cleared Oct 26, 2018
Hair Laser Headband
K182501 · OAP
Pulsaderm, LLC
General & Plastic Surgery · 44d
Cleared Oct 26, 2018
A6 OTC Pain Relief TENS
K182753 · NUH
Everyway Medical Instruments Co.,Ltd
Neurology · 28d
Cleared Oct 26, 2018
V2 OTC Pain Relief TENS
K182767 · NUH
Everyway Medical Instruments Co.,Ltd
Neurology · 28d
Cleared Oct 25, 2018
Swaive Thermometer SWT1A
K170723 · FLL
E-Care Technology Co., Ltd.
General Hospital · 595d
Cleared Oct 25, 2018
Endocular Viewing Lenses and Silicone Ring
K173944 · HJK
Phakos
Ophthalmic · 303d