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

NBW 2017-03-09

BGM009 Plus Blood Glucose Monitoring System

Applicant Apex BioTechnology Corp.

K-Number K170267

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BWK 2017-03-09

ANSiStim-PP

Applicant Dyansys, Inc.

K-Number K170391

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NEY 2017-03-09

FLEX Microwave Ablation System and Accessories

Applicant Neuwave Medical, Inc.

K-Number K163118

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NKB 2017-03-09

NuVasive® Reline® 4.5-5.0 System

Applicant Nu Vasive, Incorporated

K-Number K170126

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JFM 2017-03-09

ADVIA® Chemistry Total Bilirubin_2 (TBIL_2)

Applicant Siemens Healthcare Diagnostics, Inc.

K-Number K170065

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NKB 2017-03-09

Sterispine PS

Applicant Safe Orthopaedics

K-Number K170528

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FPA 2017-03-08

Q2 Low Pressure Power Injection Extension Set

Applicant Quest Medical, Inc.

K-Number K162804

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GEI 2017-03-08

Bovie J-Plasma Precise Open handpiece & Bovie Ultimate Gen 2 High Frequency Electrosurgical Generator

Applicant Bovie Medical Corporation

K-Number K170188

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GCJ 2017-03-08

VersaOne fascial closure system bladed trocar, VersaOne fascial closure system bladeless trocar, VersaOne fascial closure system optical trocar

Applicant Covidien, LLC

K-Number K163654

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HWC 2017-03-08

OrthoSolutions 'System26' Bone Screws

Applicant Ortho Solutions UK Limited

K-Number K163489

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KPT 2017-03-08

CRC-77tHR

Applicant Capintec, Inc.

K-Number K162394

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MMX 2017-03-08

Expro Elite Snare, Sympro Elite Snare

Applicant Vascular Solutions, Inc.

K-Number K163307

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