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

GAW 2019-06-14

Silhouette Featherlift / Silhouette Lift

Applicant Silhouette Lift, Inc.

K-Number K191299

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DQK 2019-06-14

VIVO

Applicant Catheter Precision, Inc.

K-Number K183195

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PIF 2019-06-14

Moss Gastrostomy Tube, Moss Nasal Tube – Mark IV

Applicant Moss Tubes, Inc.

K-Number K190414

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NIE 2019-06-14

Trio-CT Triple Lumen Catheter

Applicant Medical Components, Inc. (dba MedComp)

K-Number K183219

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KWS 2019-06-14

AEQUALIS FLEX REVIVE Shoulder System

Applicant Tornier, Inc.

K-Number K191318

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GXY 2019-06-14

ELECTRODES PAD

Applicant Shenzhen Bestpad Technology Development Co., Ltd.

K-Number K190700

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KNT 2019-06-14

ENvizion Medical ENVue SYSTEM, ENvizion Medical Enteral Feeding Tube

Applicant Envizion Medical , Ltd.

K-Number K191387

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DSP 2019-06-13

Fiberoptix IAB

Applicant Arrow International, Inc.

K-Number K190117

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HWC 2019-06-13

Treace Medical Concepts (TMC) Snap-Off Screw System

Applicant Treace Medical Concepts, Inc.

K-Number K183363

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QAS 2019-06-13

HealthICH

Applicant Zebra Medical Vision, Ltd.

K-Number K190424

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EOX 2019-06-13

Strome-Blitzer Cytology Balloon

Applicant Adn International, LLC

K-Number K182159

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DQK 2019-06-13

Edwards Pressure Cable

Applicant Edwards Lifesciences, LLC

K-Number K191089

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