Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k) Clearances

510(k) cleared devices tracked by MedTracker

GXY 2018-05-18

EEG-Now

Applicant Encephalodynamics, Inc.

K-Number K180524

View Details →

GEX 2018-05-18

JOULE SYSTEM

Applicant Sciton, Inc

K-Number K180508

View Details →

HRX 2018-05-18

DTRAX Spinal System

Applicant Providence Medical Technology, Inc.

K-Number K180876

View Details →

LCX 2018-05-18

Acro HCG Pregnancy Rapid Test

Applicant Acro Biotech, Inc.

K-Number K180771

View Details →

FYD 2018-05-18

Smoklean

Applicant Sejong Medical Co., Ltd.

K-Number K173108

View Details →

PWH 2018-05-17

CADD Yellow High Volume Administration Set with NRFit connector

Applicant Smiths Medical Asd, Inc.

K-Number K172592

View Details →

ODP 2018-05-17

InTice-C Porous Ti Cervical Interbody System

Applicant X-Spine Systems, Inc.

K-Number K173832

View Details →

MSD 2018-05-17

15.5F X 19 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 23 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 28 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 33 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 37 cm Symetrex Long Term Hemodialysis Catheter with Sideholes

Applicant Medical Components, Inc. (dba MedComp)

K-Number K173667

View Details →

QBR 2018-05-17

TrueTear Intranasal Tear Neurostimulator

Applicant Allergan

K-Number DEN170086

View Details →

PLA 2018-05-17

EnsoETM

Applicant Advanced Cooling Therapy, Inc. D/B/A Attune Medical

K-Number K180742

View Details →

OLO 2018-05-17

Navigated INFINITY Instruments

Applicant Medtronic Sofamor Danek USA, Inc.

K-Number K181111

View Details →

FIE 2018-05-17

Dimesol Disposable AV Fistula Needle Set (Non-Safety Series) and Dimesol Disposable AV Fistula Needle Set (Safety Series)

Applicant Dimesol, Inc.

K-Number K171505

View Details →

Page 2072 of 2685

↑