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

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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DRE 2022-08-24

TightRail Guardian Motorized Dilator Sheath

Applicant Spectranetics, Inc.

K-Number K212784

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NUH 2022-08-24

Transcutaneous Electrical Nerve Stimulator, Model: KTR-405

Applicant Shenzhen Kentro Medical Electronics Co., Ltd.

K-Number K220998

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HQC 2022-08-24

miCOR System Lens Fragmentation System

Applicant Carl Zeiss Meditec Cataract Technology, Inc.

K-Number K222236

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FMI 2022-08-23

Disposable Medical Safety Hypodermic Needle

Applicant Hantech Medical Device Co., Ltd.

K-Number K220603

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GEX 2022-08-23

Picosecond Laser System (Model PS10-A and PS10-B)

Applicant Beijing Adss Development Co., Ltd.

K-Number K220268

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EMA 2022-08-23

Bifix Hybrid Abutment Cement

Applicant Voco GmbH

K-Number K220640

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HBE 2022-08-23

2.1 x 255mm Drill, 22mm Stop

Applicant Biomet Micofixation

K-Number K213072

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MBH 2022-08-23

GMK 3D Metal Tibial Tray

Applicant Medacta International S.A.

K-Number K221850

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