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

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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OBP 2016-12-22

Neurosoft TMS

Applicant Teleemg, LLC

K-Number K160309

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CHH 2016-12-22

CardioChek Plus Test System, CardioChek Home Test System, CardioChek PA Test System, CardioChek PA Home Test System

Applicant Polymer Technology Systems, Inc.

K-Number K151545

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GKZ 2016-12-22

Sysmex XN-L Automated Hematology Analyzer

Applicant Sysmex America, Inc.

K-Number K160538

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KRX 2016-12-22

XN CAL

Applicant Streck

K-Number K160585

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NKG 2016-12-22

neon3 universal OCT spinal stabilization

Applicant Ulrich GmbH & Co. KG

K-Number K161032

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