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

LNH 2017-10-12

MAGNETOM Terra

Applicant Siemens Medical Solutions USA, Inc.

K-Number K170840

View Details →

DSP 2017-10-12

CS100/CS100i Intra-Aortic Balloon Pump, CS300 Intra-Aortic Balloon Pump

Applicant Datascope Corp.

K-Number K172305

View Details →

KTT 2017-10-12

Galaxy UNYCO System

Applicant Orthofix Srl

K-Number K170146

View Details →

DPS 2017-10-12

Creavo Vitalscan Magnetocardiograph

Applicant Creavo Medical Technologies, Ltd.

K-Number K170154

View Details →

MAX 2017-10-11

NuVasive® Modulus XLIF Interbody System

Applicant Nu Vasive, Incorporated

K-Number K172123

View Details →

FZP 2017-10-11

AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (PRO2)

Applicant AtriCure, Inc.

K-Number K172742

View Details →

FMI 2017-10-11

Clickfine Pen Needle, Penfine Classic Pen Needle

Applicant Ypsomed AG

K-Number K171984

View Details →

HEB 2017-10-11

U by Kotex Click Unscented Menstrual Tampons

Applicant Kimberly-Clark Corporation

K-Number K172118

View Details →

CCK 2017-10-11

Nihon Kohden CO2 Monitor

Applicant Nihon Kohden Corporation

K-Number K171765

View Details →

KNT 2017-10-11

Stomach Tube

Applicant Well Lead Medical Co., Ltd.

K-Number K162340

View Details →

DXN 2017-10-10

higi Station (with Body Composition and Pan and Tilt cuff housing), higi Station ( with Body Composition and Fixed cuff housing)

Applicant Higi Sh, LLC

K-Number K172739

View Details →

NKB 2017-10-10

XIA® 4.5 Spinal System, Power Adaptor Instrument Accessory

Applicant Stryker Corporation

K-Number K172724

View Details →

Page 2236 of 2685

↑