Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) 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

CGA 2016-12-22

CardioChek Plus Test System, CardioChek Home Test System

Applicant Polymer Technology Systems, Inc. D/B/A Pts Diagnostics

K-Number K162282

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ELC 2016-12-22

Y-MIC

Applicant Micron Corporation

K-Number K161639

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FTL 2016-12-22

DynaMesh-VENTRAL

Applicant Feg Textiltechnik Forschungs- Und Entwicklungsgesellschaft

K-Number K161550

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PMS 2016-12-22

ivWatch

Applicant Ivwatch, LLC

K-Number K162478

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JPK 2016-12-22

XN CHECK

Applicant Streck

K-Number K160590

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MAX 2016-12-22

FORZA Spacer System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, SKYHAWK Lateral Interbody Fusion System

Applicant Orthofix, Inc.

K-Number K162446

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NRB 2016-12-22

Stimucel System, Stimucel Generator, Stimucel Treatment Wand, Stimucel Applicator

Applicant Alliqua Biomedical, Inc.

K-Number K162721

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ODP 2016-12-22

The Small PLATEAU (PLATEAU-C) Spacer System

Applicant Life Spine, Inc.

K-Number K161127

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FAD 2016-12-22

pAguaMedicina PERSISTENT Structural Hydrogel Ureteral Stent

Applicant Q Urological Corporation

K-Number K163068

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NDC 2016-12-22

Go Dose System

Applicant Eli Lilly and Company

K-Number K160949

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MHX 2016-12-22

Patient Monitor

Applicant Edan Instruments, Inc.

K-Number K160981

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PPN 2016-12-22

Lithoplasty Peripheral Balloon Dilatation Catheter; Lithoplasty Generator And Connector Cable; Lithoplasty Connector Cable

Applicant Shockwave Medical, Inc.

K-Number K163306

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