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

DZE 2018-06-28

KJ ZIRCONIA Implant System

Applicant Kj Meditech Co., Ltd.

K-Number K173116

View Details →

PZX 2018-06-28

ArtiClip LAA Exclusion System

Applicant AtriCure, Inc.

K-Number K181474

View Details →

GEX 2018-06-28

Beacon Advanced CO2 Laser System

Applicant Omniguide, Inc.

K-Number K180993

View Details →

MAX 2018-06-28

Juliet Ti

Applicant Spineart

K-Number K181203

View Details →

FTL 2018-06-28

PROLENE Polypropylene Mesh Non-Absorbable Synthetic Surgical Mesh, PROLENE (Polypropylene) Hernia System, Non-absorbable Synthetic Surgical Mesh

Applicant ETHICON, Inc.

K-Number K180829

View Details →

DPW 2018-06-28

Deltex Medical CardioQ-EDM+, Deltex Medical CardioQ-EDM

Applicant Deltex Medical Limited

K-Number K172457

View Details →

OHT 2018-06-28

Beurer IPL 5500 device/ IPL 5000/ IPL PureSkin Pro

Applicant Home Well Trading, Ltd.

K-Number K181121

View Details →

PWJ 2018-06-28

GYNECARE TVT Abdominal Guides and Couplers, GYNECARE TVT Reuseable Introducer, GYNECARE TVT Reusable Rigid Catheter Guide

Applicant ETHICON, Inc.

K-Number K173162

View Details →

EBG 2018-06-28

TEMP BASIC, TEMP PREMIUM, TEMP PREMIUM FLEXIBLE, MULTISTRATUM FLEXIBLE, THERAPON, TRY-IN, BURNOUT, TRY-IN & BURNOUT

Applicant Zirkonzahn GmbH

K-Number K180562

View Details →

LOX 2018-06-28

Sapphire II PRO Balloon Dilatation Catheter

Applicant Orbusneich Medical Trading, Inc.

K-Number K180921

View Details →

KOD 2018-06-28

Angled Tip Ureteral Catheter

Applicant Cook Incorporated

K-Number K181144

View Details →

MRW 2018-06-28

FaSet Fixation System

Applicant Huvexel Co. , Ltd.

K-Number K180729

View Details →

Page 2043 of 2685

↑