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

GCJ 2016-10-24

Standard Clamp

Applicant Standard Bariatrics

K-Number K161720

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PGW 2016-10-24

Acclarent NavWire Sinus Navigation Guidewire

Applicant Acclarent, Inc.

K-Number K161697

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DXN 2016-10-24

Automatic Arm Bluetooth Blood Pressure Monitor

Applicant Truly Instrument Limited

K-Number K161846

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LRC 2016-10-24

Relieva UltirraNav Sinus Balloon Catheter

Applicant Acclarent, Inc.

K-Number K161698

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EBF 2016-10-24

Capo Hybrid, Capo Slow Flow, Capo Flow, Capo Natural, Capo Universal, Nano Paq, Nano Paq Flow

Applicant Schutz Dental GmbH

K-Number K151399

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KYF 2016-10-24

Ahmed Glaucoma Valve

Applicant New World Medical, Inc.

K-Number K162060

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PGW 2016-10-24

CARTO ENT System

Applicant Biosense Webster

K-Number K161701

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JDR 2016-10-24

NeoSpan Compression Staple Impant w/instruments

Applicant In2bones USA, LLC

K-Number K161426

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BSP 2016-10-21

SPROTTE NRFit, Quincke NRFit Lumbar Puncture needles

Applicant PAJUNK GmbH Medizintechnologie

K-Number K160294

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DQK 2016-10-21

Ensite Velocity Cardiac Mapping System v5.0, Ensite Automap Module v1.0

Applicant St Jude Medical

K-Number K160187

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BZC 2016-10-21

MiniBox +

Applicant Pulmone Advanced Medical Devices, Ltd.

K-Number K161295

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IZL 2016-10-21

Paragon 2

Applicant Meridian Medical Systems, LLC

K-Number K162687

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