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

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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LNH 2021-11-24

AMRA Profiler

Applicant Amra Medical AB

K-Number K211983

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QAI 2021-11-24

MicroPen EVO

Applicant Eclipse Medcorp, LLC

K-Number K212558

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OWB 2021-11-24

ControlRad Select Model Z

Applicant Controlrad, Inc.

K-Number K213455

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JFY 2021-11-24

Atellica CH Enzymatic Creatinine_3 (ECre3)

Applicant Siemens Healthcare Diagnostics, Inc.

K-Number K212223

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