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

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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GEI 2022-09-08

Ellusa Reusable Neutral Plates

Applicant Ellusa, LLC

K-Number K222425

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HAW 2022-09-08

Cranial EM System

Applicant Brainlab AG

K-Number K213989

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MBI 2022-09-07

FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire, FiberStitch Implant, Straight with two Polyester Implants and 2-0 FiberWire

Applicant T.A.G. Medical Products Corporation, Ltd.

K-Number K221731

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PCU 2022-09-07

AXIOS Stent and Electrocautery-Enhanced Delivery System

Applicant Boston Scientific Corporation

K-Number K220112

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QRL 2022-09-07

RightLance Blood Lancing System

Applicant Beijing Ruicheng Medical Supplies Co., Ltd.

K-Number K222034

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