Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) 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

FTC 2018-10-29

ClearLink Controlled Phototherapy Equipment

Applicant Daavlin Distributing Company

K-Number K182215

View Details →

PGI 2018-10-29

HSV 1 & 2 ELITe MGB Kit; ELITe InGenius

Applicant Elitechgroup

K-Number K180559

View Details →

FLL 2018-10-29

Infrared Forehead Thermometer, Infrared Ear/Forehead Thermometer

Applicant Joytech Healthcare Co. , Ltd.

K-Number K181239

View Details →

NLH 2018-10-27

Reprocessed Advisor FL Sensor Enabled Circular Mapping Catheter

Applicant Innovative Health, LLC

K-Number K181458

View Details →

NKB 2018-10-27

ORTHROS™ Posterior Stabilization System; ORTHROS™ MIS Posterior Stabilization System

Applicant Camber Spine Technologies, LLC

K-Number K180980

View Details →

BZH 2018-10-26

Peak.me

Applicant Breathe Me, Ltd.

K-Number K180487

View Details →

LKF 2018-10-26

Cook Silicone Balloon HSG Catheter

Applicant Cook Incorporated

K-Number K180291

View Details →

NXC 2018-10-26

Invisalign System with Mandibular Advancement Feature

Applicant Align Technology, Inc.

K-Number K181739

View Details →

DQO 2018-10-26

Polyethylene Catheter

Applicant Cook Incorporated

K-Number K180286

View Details →

LNH 2018-10-26

MAGNETOM Aera

Applicant Siemens Medical Solutions USA, Inc.

K-Number K182299

View Details →

QAS 2018-10-26

Accipiolx

Applicant Maxq-Al , Ltd.

K-Number K182177

View Details →

LKF 2018-10-26

Margolin HSG Cannula, Goldstein Sonohysterography Catheter

Applicant Cook Incorporated

K-Number K180300

View Details →

Page 2025 of 2738

↑