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

GCJ 2022-08-25

LapBox Tissue Containment Removal System

Applicant Ark Surgical, Ltd.

K-Number K221365

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LZA 2022-08-25

Nitrile Exam Gloves (Blue, Black)

Applicant Hebei Astro Medical Supply Co., Ltd.

K-Number K221143

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PBX 2022-08-25

Apollo Duet (Model : APD-4000)

Applicant Weero Co.

K-Number K212253

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OSN 2022-08-25

Acute QC Strut and Components

Applicant Smith & Nephew, Inc.

K-Number K221792

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NGX 2022-08-25

WiEMSpro

Applicant Medical Cables S.L.

K-Number K211298

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OBP 2022-08-24

NeuroStar, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar Advanced Therapy System for Mental Health

Applicant Neuronetics, Inc.

K-Number K222230

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QKB 2022-08-24

AutoContour Model RADAC V2

Applicant Radformation, Inc.

K-Number K220598

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FXX 2022-08-24

The GOOD High Fluid-Resistant Surgical Mask, The GOOD High Fluid-Resistant Surgical Procedure KF Mask, The GOOD Super Guard Design High Fluid-Resistant Surgical Mask, The KOEASY High Fluid-Resistant Surgical Mask, The KOEASY High Fluid-Resistant Surgical Procedure KF Mask, The KOEASY Super Guard Design High Fluid-Resistant Surgical Mask

Applicant The Good Corporation

K-Number K211771

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HRS 2022-08-24

ARIX Small Fragment System

Applicant Jeil Medical Corporation

K-Number K221920

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LJS 2022-08-24

Sherlock 3CG® Tip Positioning System (TPS) Stylet/T-Lock Assembly

Applicant Bard Access Systems, Inc.

K-Number K222232

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PMS 2022-08-24

ivWatch Model 400

Applicant Ivwatch, LLC

K-Number K222212

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GEX 2022-08-24

V-Laser

Applicant Wontech Co., Ltd.

K-Number K221427

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