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

GEH 2021-11-29

C2 CryoBalloon Ablation System

Applicant Pentax of America, Inc.

K-Number K212814

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PBF 2021-11-29

3D-Cut

Applicant 3D-Side S.A.

K-Number K212237

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FRA 2021-11-26

CUBE Air Purifier

Applicant Samsung Electronics Co., Ltd.

K-Number K211139

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FJK 2021-11-26

Tablo Cartridge

Applicant Outset Medical, Inc.

K-Number K210782

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LYZ 2021-11-26

Synthetic Nitrile Examination Gloves

Applicant Shandong Hongxin Chemicals Co., Ltd.

K-Number K212488

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LZA 2021-11-26

Nitrile Examination Gloves

Applicant Wuhan Huirui Technology Co., Ltd.

K-Number K212722

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QJP 2021-11-26

Trevo Trak 21 Microcatheter

Applicant Stryker Neurovascular

K-Number K211594

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JOH 2021-11-26

Portex BLUxl Extra Length Tracheostomy Tube, BLUxl Suctionaid Extra Length Tracheostomy Tube, BLUxl Extra Length Tracheostomy Inner Cannula

Applicant Smiths Medical Asd, Inc.

K-Number K210833

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FXX 2021-11-26

Medical surgical mask

Applicant Henan Huibo Medical Co., Ltd.

K-Number K202842

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OBP 2021-11-26

ALTMS Magnetic Stimulation Therapy System

Applicant Remed Co., Ltd.

K-Number K202537

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QDQ 2021-11-26

MammoScreen 2.0

Applicant Therapixel

K-Number K211541

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HRS 2021-11-24

The Radian MIS Bunion System

Applicant Nvision Biomedical Technologies, Inc.

K-Number K211650

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