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

BTA 2016-01-28

TACVAC

Applicant Athena Gtx

K-Number K153459

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NKB 2016-01-28

Seneka II Polyscrew Pedicle Fixation System

Applicant Senecka Spine

K-Number K153525

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HRS 2016-01-28

Cable-Ready Cable Grip System: Cable-Ready Bone Plate System

Applicant Zimmer, Inc.

K-Number K151716

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JDR 2016-01-28

dynaMX Tabbed Staple

Applicant Mx Orthopedics, Corp.

K-Number K153129

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LYA 2016-01-28

SPIWay Endonasal Access Guide

Applicant Spiway, LLC

K-Number K153686

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MAX 2016-01-28

Half Dome Posterior Lumbar Interbody System

Applicant Astura Medical

K-Number K152512

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DZE 2016-01-28

QUAD Dental Implants and Prostheses

Applicant Dentack Impants, Ltd.

K-Number K152188

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LJS 2016-01-28

CG+ Arrow JACC powered by Arrow VPS Stylet, CG+ Arrow JACC

Applicant Arrow International, Inc. (Subsidiary of Teleflex, Inc.)

K-Number K153423

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JJY 2016-01-28

VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7 Verification Kit, VK-Crea Verification Kit

Applicant Radiometer America, Inc.

K-Number K153712

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OMP 2016-01-28

PICO Single Use Negative Pressure Wound Therapy System

Applicant Smith & Nephew Medical, Ltd.

K-Number K151436

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MBI 2016-01-28

Adjustable Fixation Device

Applicant Arthrocare Corp.

K-Number K153186

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JFM 2016-01-28

Total Bilirubin

Applicant Randox Laboratories Limited

K-Number K152344

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