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

IPL 2022-02-10

Action Trackchair Hawk

Applicant Action Manufacturing, Inc.

K-Number K202728

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OKO 2022-02-10

NPseal

Applicant Guard Medical, Inc.

K-Number K212971

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JXI 2022-02-10

NervAlign Nerve Cuff

Applicant Renerve, Ltd.

K-Number K202234

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HSB 2022-02-10

GPC Intraheal Intramedullary Nailing System

Applicant Gpc Medical Limited

K-Number K203811

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QJP 2022-02-10

Micro Catheter

Applicant Shanghai Heartcare Medical Technology Co., Ltd.

K-Number K202926

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QSY 2022-02-10

Zeolite Hemostatic Gauze

Applicant Hangzhou Zeo-Innov Life Technology Co., Ltd.

K-Number K211570

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FMF 2022-02-10

Instylla Delivery Kit

Applicant Instylla, Inc.

K-Number K213632

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DRF 2022-02-10

Khelix Steerable Electrophysiology Catheters, Khelix Loop Fixed Electrophysiology Catheters, Khelix Fixed Loop Steerable Electrophysiology Catheters, Khelix Variable Loop Steerable Electrophysiology Catheters

Applicant CathRx, Ltd.

K-Number K211327

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NXC 2022-02-09

Redline

Applicant Johns Dental Laboratories

K-Number K213297

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DQX 2022-02-09

R350 guidewire, Spectre guidewire, Raider guidewire, Bandit guidewire, Warrior guidewire

Applicant Vascular Solutions, LLC

K-Number K212167

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PEB 2022-02-09

Actively Trying Personal Lubricant Unfragrance

Applicant CC Wellness, LLC

K-Number K212705

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JOW 2022-02-09

Veinoflow SCD (Model: LBTK-M-I 5006)

Applicant Dalian Labtek Science & Development Co., Ltd.

K-Number K213313

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