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

LPL 2017-06-02

PolyDev Soft Contact Lenses

Applicant Polydev , Ltd.

K-Number K171157

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LZO 2017-06-02

Responsive Orthopedics Total Hip Arthroplasty System

Applicant Responsive Orthopedics, LLC

K-Number K163585

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PNE 2017-06-02

Reprocessed Agilis NxT Steerable Introducer

Applicant Innovative Health, LLC

K-Number K170311

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DPS 2017-06-02

Electrocardiograph

Applicant Edan Instruments, Inc.

K-Number K170995

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OWB 2017-06-02

Dynamic Coronary Roadmap

Applicant Philips Medical Systems Nederland B.V.

K-Number K170130

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ODP 2017-06-01

MATISSE Anterior Cervical Interbody Fusion Cage System

Applicant Ctl Medical Corporation

K-Number K162682

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PND 2017-06-01

PowerGlide ST Midline Catheter

Applicant C.R. Bard, Inc.

K-Number K170158

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NZT 2017-06-01

OARtrac System with Patient Specific Reusable Universal PSD Sensors

Applicant Radiadyne, LLC

K-Number K162954

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KHS 2017-06-01

Carbon Dioxide Reagent Set

Applicant Teco Diagnostics, Inc.

K-Number K170200

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PRI 2017-06-01

ARCHITECT B.R.A.H.M.S PCT, ARCHITECT B.R.A.H.M.S PCT Calibrators, ARCHITECT B.R.A.H.M.S PCT Controls

Applicant Fisher Diagnostics

K-Number K170652

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GCJ 2017-06-01

Xenocor Xenoscope Laparoscopic System

Applicant Xenocor, Inc.

K-Number K171344

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DRE 2017-06-01

Medcomp Vessel Dilator

Applicant Medcomp ( Medical Components)

K-Number K162389

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