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

DTK 2016-04-29

Denali Filter System - Femoral Delivery Kit, Denali Filter System - Jugular/Subclavian Delivery Kit

Applicant C.R. Bard, Inc.

K-Number K160866

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LIT 2016-04-29

Crosstella OTW

Applicant KANEKA Corporation

K-Number K160004

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MHX 2016-04-29

Patient Monitor

Applicant Edan Instruments, Inc.

K-Number K152552

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HQE 2016-04-29

Bi-Blade Vitrectomy Cutter

Applicant Medical Instrument Development Laboratories

K-Number K153168

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LZO 2016-04-29

REVIVAL(TM) Modular Revision Hip Stem

Applicant Corin USA

K-Number K152903

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CBF 2016-04-29

Rectangular Multiplace Hyperbaric Chamber System Product Family with Touchscreen Control System

Applicant Oxyheal Medical Systems, Inc.

K-Number K152223

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MHX 2016-04-29

Dyna-Vision Telemonitoring System

Applicant Techmedic Development International B.V.

K-Number K152973

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LIT 2016-04-29

Crosperio OTW

Applicant KANEKA Corporation

K-Number K160013

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NAY 2016-04-29

da Vinci Xi Surgical System

Applicant Intuitive Surgical

K-Number K152892

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HWC 2016-04-29

MC-Subtalar(TM) II

Applicant Merete Medical GmbH

K-Number K160548

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LPH 2016-04-29

Bencox M Stem (Bencox Hip System) and Bencox ID Cemented Stem (with Centralizer) & Bencox Bone Plug

Applicant Corentec Co., Ltd.

K-Number K152084

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LEJ 2016-04-29

T-32;T-40;T-44;T-52;T-72;TT-50

Applicant Tanses Technologies, Inc.

K-Number K152412

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