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

PSW 2023-06-07

Ethos Automated Ultrasound Probe Cleaner Disinfector with AquaCide Cleaner/High-Level Disinfectant and QwikCheck Chemical Indicator

Applicant Cs Medical, LLC

K-Number K230381

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OVE 2023-06-07

Xenco Medical InterAlign Cervical Interbody System

Applicant Xenco Medical, LLC

K-Number K223059

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PGY 2023-06-07

C350/C350G LCD Monitor; M550/M550G LCD Monitor

Applicant Nanjing Jusha Display Technology Co., Ltd.

K-Number K231170

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QIH 2023-06-06

FEops HEARTguideTM, FEops HEARTguideTM ALPACA

Applicant Feops NV

K-Number K223855

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QWB 2023-06-06

Cue COVID-19 Molecular Test

Applicant Cue Health, Inc.

K-Number DEN220028

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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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