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

GEI 2016-10-21

Ambient HipVac 50 Wand with Integrated Finger Switches

Applicant ArthroCare Corporation

K-Number K161481

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NEZ 2016-10-21

CapsoCam Plus (SV-3) Capsule Endoscope System

Applicant CapsoVision, Inc.

K-Number K161773

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HRS 2016-10-21

Distal Radius Plating System

Applicant Miami Device Solutions, LLC

K-Number K162635

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LLZ 2016-10-21

Artemis

Applicant Eigen

K-Number K162474

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JLW 2016-10-21

Automated Immunoassay System HISCL -800, HISCL TSH Assay Kit, HISCL TSH Calibrator, HISCL Immuno Multi Control

Applicant Sysmex America, Inc.

K-Number K160541

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NHV 2016-10-21

NOSOGARD FILTERS

Applicant Evoqua Water Technologies, LLC

K-Number K153784

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PGW 2016-10-21

KARL STORZ NAV1 Electromagnetic Navigation System

Applicant Karl Storz Endoscopy America, Inc.

K-Number K161555

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DZE 2016-10-21

KJ Mini Implant System

Applicant Kj Meditech Co., Ltd.

K-Number K151970

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LPL 2016-10-21

Saview-Colors Aqua 42 UV (hefilcon A) Soft (Hydrophilic) Contact Lens, Saview-Colors Aqua 42 UV Toric (hefilcon A) Soft (Hydrophilic) Contact Lens, Saview-Colors Aqua 42 UV Multifocal (hefilcon A) Soft (Hydrophilic) Contact Lens

Applicant St. shine Optical Co., Ltd.

K-Number K162317

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OVE 2016-10-21

Xenco Medical Cervical Interbody System

Applicant Xenco Medical, LLC

K-Number K160313

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FTM 2016-10-21

Gentrix Surgical Matrix

Applicant Acell, Inc.

K-Number K162554

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PGN 2016-10-21

MAGEC® Spinal Bracing and Distraction System

Applicant Nuvasive Specialized Orthopedics, Inc.

K-Number K160352

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