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

BZD 2020-10-29

WiZARD 510 Nasal Mask

Applicant Apex Medical Corp.

K-Number K193206

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JAK 2020-10-29

LSN

Applicant Imaging Biometrics, LLC

K-Number K201092

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OLZ 2020-10-29

Sleepware G3

Applicant Respironics, Inc.

K-Number K202142

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LLZ 2020-10-29

CloudVue

Applicant International Medical Solutions, Inc.

K-Number K203058

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FAJ 2020-10-29

Flexible Video Cysto-Urethroscope (C-view)

Applicant KARL STORZ Endoscopy-America, Inc.

K-Number K202957

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KLE 2020-10-28

Bright Bond Universal

Applicant Genoss Co., Ltd.

K-Number K200153

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NEY 2020-10-28

NP1 Instrument, Creo Electrosurgical System

Applicant Creo Medical, Ltd.

K-Number K200003

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MBI 2020-10-28

Parcus GFS II and GFS Mini, GFS Naked, GFS Ultimate, GFS BTB, ATLAS, Synd-EZ Ti, Actiflip Naked, Actiflip Cinch, Actiflip Whip, and GFS Ultimate Hip

Applicant Parcus Medical, LLC

K-Number K202259

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HSB 2020-10-28

Syntec Femoral Nail Extended System

Applicant Syntec Scientific Corporation

K-Number K202935

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JDQ 2020-10-28

EVOS Cabling System

Applicant Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)

K-Number K201497

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DXT 2020-10-28

Sterile High-pressure Angiographic Syringes for single-use

Applicant Youwo (Guangzhou) Medical Device Co., Ltd.

K-Number K201395

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PBX 2020-10-28

Ultimate Contour, Ultimate Contour Mini

Applicant CAO Group, Inc.

K-Number K201475

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