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 2020-11-20

TIPCAM1 Rubina Video Endoscope System

Applicant Karl Storz Endoscopy America

K-Number K201526

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FXX 2020-11-20

Medical surgical mask

Applicant Guangdong Kingfa Sci. & Tech.Co., Ltd.

K-Number K202139

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QMV 2020-11-20

FilmArray Global Fever Panel

Applicant Biofire Defense, LLC

K-Number DEN200043

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POL 2020-11-20

Solitaire Platinum Revascularization Device, Solitaire X Revascularization Device (Solitaire Revascularization Device)

Applicant Micro Therapeutics, Inc. d/b/a ev3 Neurovascular

K-Number K193576

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DWM 2020-11-20

Passio Pump Drainage System

Applicant Bearpac Medical

K-Number K201404

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FED 2020-11-20

Dornier MAGELLAN Ureteral Access Sheath

Applicant Dornier Medtech America, Inc.

K-Number K201815

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QAS 2020-11-20

HALO

Applicant Nico-Lab B.V.

K-Number K200873

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DTR 2020-11-20

MPS 3 ND Myocardial Protection System

Applicant Quest Medical, Inc.

K-Number K201984

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OBP 2020-11-20

NeuroStar Advanced Therapy

Applicant Neuronetics, Inc.

K-Number K201158

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OLR 2020-11-20

Silatrix Oral Gel

Applicant Sa3, LLC

K-Number K202000

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MQL 2020-11-20

V-ONESTEP

Applicant Vitromed GmbH

K-Number K193285

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HBA 2020-11-20

Codman Surgical Patties & Strips

Applicant Integra LifeSciences Corporation

K-Number K193346

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