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

QRL 2022-11-30

Lancing System, Sterile Lancet for Single Use, Lancing Device

Applicant Shandong Lianfa Medical Plastic Products Co. , Ltd.

K-Number K222472

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GDW 2022-11-30

EEA Circular Stapler with Tri-Staple Technology

Applicant Covidien

K-Number K221771

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FRA 2022-11-30

Purgo

Applicant Aeroclean Technologies, Inc.

K-Number K223328

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FYC 2022-11-30

Paneffort AAMI Level 3 Isolation Gown

Applicant Paneffort, LLC

K-Number K212717

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LCX 2022-11-30

MissLan™ Digital Pregnancy Rapid Test

Applicant Guangzhou Decheng Biotechnology Co., Ltd.

K-Number K222305

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LZA 2022-11-30

Rhino Non-Sterile, Powder-Free Nitrile Exam Gloves – Periwinkle Color Tested for Use with Chemotherapy Drugs, and Fentanyl

Applicant Rhino Health, Inc.

K-Number K221082

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OWN 2022-11-29

SmartSurgN Visualization System

Applicant Smartsurgn Incorporated

K-Number K213943

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QFR 2022-11-29

QStat Cartridge

Applicant Hemosonics, LLC

K-Number K213917

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FMK 2022-11-29

Disposable Safety Lancet

Applicant Beijing Ruicheng Medical Supplies Co., Ltd.

K-Number K222408

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GDW 2022-11-29

Signia™ Small Diameter Reloads Including Regular (Round) Tip Version

Applicant Covidien

K-Number K222641

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MBI 2022-11-28

Aevumed PHANTOM™-LP Suture Anchors

Applicant Aevumed, Inc.

K-Number K222363

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QRL 2022-11-28

Facet Manatee Reusable Lancing Base

Applicant Facet Technologies, LLC

K-Number K223099

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