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

OSP 2017-02-07

PUREtrace

Applicant Nemo Healthcare BV

K-Number K153262

View Details →

LKF 2017-02-07

Unicare System, Unicare Manipulator

Applicant Clearpath Surgical, Inc.

K-Number K163214

View Details →

NKG 2017-02-07

Proficient Posterior Cervical Spine System

Applicant Spine Wave, Inc.

K-Number K162639

View Details →

GYB 2017-02-07

EndyGel

Applicant Endymed Medical, Ltd.

K-Number K161715

View Details →

LRK 2017-02-07

Fuselier Intraoral Nighttime Device (FIND)

Applicant Fuselier Enterprises, LLC

K-Number K161980

View Details →

KWY 2017-02-07

Fitmore® Hip Stem

Applicant Zimmer GmbH

K-Number K170072

View Details →

FGE 2017-02-07

Zilver 518TM Biliary Stent; Zilver 635TM Biliary Stent

Applicant Cook Ireland, Ltd.

K-Number K163169

View Details →

LZA 2017-02-06

NITRILE POWDER FREE EXAMINATION GLOVE TESTED FOR USE WITH CHEMOTHERAPY DRUGS - AQUA BLUE; NITRILE POWDER FREE EXAMINATION GLOVE TESTED FOR USE WITH CHEMOTHERAPY DRUGS - VIOLET BLUE; NITRILE POWDER FREE EXAMINATION GLOVE TESTED FOR USE WITH CHEMOTHERAPY DRUGS - DARK BLUE; NITRILE POWDER FREE EXAMINATION GLOVE TESTED FOR USE WITH CHEMOTHERAPY DRUGS - DARK VIOLET BLUE

Applicant Hartalega NGC Sdn. Bhd.

K-Number K162923

View Details →

LLZ 2017-02-06

UC-CARE NaviGo Workstation

Applicant UC-CARE , Ltd.

K-Number K160934

View Details →

NDN 2017-02-06

DCM Kyphoplasty System

Applicant Dragon Crown Medical Co., Ltd.

K-Number K162283

View Details →

KWQ 2017-02-06

Altus Spine Cervical Plate System

Applicant Altus Partners, LLC

K-Number K163061

View Details →

NAY 2017-02-06

EndoWrist Suction Irrigator

Applicant Intuitive Surgical, Inc.

K-Number K162973

View Details →

Page 2416 of 2685

↑