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

INI 2017-02-02

Titan 3W

Applicant Tzora Active Systems , Ltd.

K-Number K160835

View Details →

DZE 2017-02-02

US SA Implant System

Applicant Osstem Implant Co., Ltd.

K-Number K161103

View Details →

PEK 2017-02-02

HA Minuteman G3-R MIS Fusion Plate

Applicant Spinal Simplicity

K-Number K163428

View Details →

DXN 2017-02-01

iHealth Wireless Blood Pressure Monitor

Applicant Andon Health Co, Ltd.

K-Number K162144

View Details →

JDR 2017-02-01

Memodyn Staple

Applicant Austin & Associates, Inc./Telos Medical Equipment

K-Number K161587

View Details →

KWD 2017-02-01

Life Spine Metatarsal Hemi Implant

Applicant Life Spine, Inc.

K-Number K161279

View Details →

MIB 2017-02-01

Pre-Formed Penile Silicone Block

Applicant International Medical Devices, Inc.

K-Number K162624

View Details →

DQY 2017-02-01

Twin-Pass Torque

Applicant Vascular Solutions, Inc.

K-Number K162467

View Details →

GEX 2017-02-01

PicoWay Laser System

Applicant Syneron Candela Corporation

K-Number K162454

View Details →

DTR 2017-02-01

MYOtherm XP Cardioplegia Delivery System with Trillium Biosurface; MYOtherm XP Cardioplegia Delivery System with Trillium Biosurface with Bridge; MYOtherm XP Cardioplegia Delivery System; MYOtherm XP Cardioplegia Delivery System with Bridge

Applicant Medtronic, Inc.

K-Number K162958

View Details →

LSR 2017-02-01

Lyme B. burgdorferi (IgG) MarStripe Test

Applicant Trinity Biotech

K-Number K163095

View Details →

PHX 2017-02-01

Exactech® Equinoxe® Preserve Stem

Applicant Exactech, Inc.

K-Number K162726

View Details →

Page 2419 of 2685

↑