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

ODP 2023-06-06

F3D Interbody System

Applicant Corelink, LLC

K-Number K230329

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LZA 2023-06-06

Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With Chemotherapy Drugs and Fentanyl)

Applicant Nephron Nitrile, LLC

K-Number K231349

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MCW 2023-06-06

Pantheris LV Atherectomy Catheter

Applicant Avinger, Inc.

K-Number K230005

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NGX 2023-06-06

Gnesis EMS Plus

Applicant Creative Fitness Developments S.L.

K-Number K230261

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NJM 2023-06-06

A-Line Advanced

Applicant Biocetec Co., Ltd.

K-Number K231635

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GEX 2023-06-06

AviClear Laser System

Applicant Cutera, Inc.

K-Number K230660

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LLZ 2023-06-06

Olea S.I.A. Neurovascular V1.0

Applicant Olea Medical

K-Number K223532

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OWQ 2023-06-06

Vein360 Reprocessed Visions PV.035 Digital IVUS Catheter

Applicant Vein 360, LLC

K-Number K230584

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GEX 2023-06-06

Diode laser therapy device

Applicant Triangel Rsd Limited

K-Number K212734

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GEX 2023-06-06

Diode laser therapy device

Applicant Beijing Star New Tech Co., Ltd.

K-Number K212733

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MWI 2023-06-06

ARC Intensive Care Information System (ARC System)

Applicant Ordinatrum Solutions

K-Number K220117

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GEI 2023-06-05

ArtiSential Laparoscopic Instruments-Electrodes

Applicant Livsmed, Inc.

K-Number K230498

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