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

GEX 2022-09-08

Dynamis Pro Family

Applicant Fotona D.O.O.

K-Number K213267

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ODC 2022-09-08

Disposable Endoscope Valves System

Applicant Changzhou Endoclean Medical Device Co., Ltd.

K-Number K221331

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ELC 2022-09-08

Ultrasonic Endo Activation Device (Model:Actor I pro)

Applicant Changzhou Bomedent Medical Technology Co.,Ltd

K-Number K213947

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LRK 2022-09-08

Soundly Anti Snoring Device

Applicant Greystone Ip, Ltd.

K-Number K220330

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NWB 2022-09-08

HD-550 Video Endoscope System

Applicant Sonoscape Medical Corp.

K-Number K222020

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LPL 2022-09-08

BARBIE (polymacon) Daily Wear Soft (Hydrophilic) Contact Lens

Applicant Shenzhen Dashicheng Optical Technology Co., Ltd.

K-Number K220143

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HWC 2022-09-08

CAPTIVATE® Compression Screws

Applicant Globus Medical, Inc.

K-Number K222409

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QFM 2022-09-08

EFAI ChestSuite XR Pleural Effusion Assessment System

Applicant Ever Fortune.Ai, Co., Ltd.

K-Number K222076

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NHA 2022-09-08

Osstem Abutment System

Applicant Osstem Implant Co., Ltd.

K-Number K221684

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KNW 2022-09-08

NeoNavia Biopsy System

Applicant Neodynamics AB

K-Number K220595

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DFH 2022-09-08

Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay

Applicant Diazyme Laboratories, Inc.

K-Number K211648

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NYI 2022-09-08

MammaPrint FFPE NGS Kit

Applicant Agendia, Inc.

K-Number K210973

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