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

QRK 2023-12-06

SG Lanset I, SG Lancets, Soft Lancets

Applicant Sewon Medical Co.

K-Number K230712

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DXH 2023-12-06

QT ECG (QTERD100)

Applicant QT Medical, Inc.

K-Number K233521

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GXD 2023-12-06

OneRF Ablation System

Applicant Neuroone Medical Technologies Corp.

K-Number K231675

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JAK 2023-12-06

Aquilion Serve SP (TSX-307B/1) V1.3

Applicant Canon Medical Systems Corporation

K-Number K233334

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MXD 2023-12-06

LINQ II Insertable Cardiac Monitor

Applicant Medtronic, Inc.

K-Number K233562

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GEX 2023-12-06

BeaMed Laser Surgery Fibers

Applicant Bt Beamedical Tachnoogies Ltd. (Beamed)

K-Number K232769

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IYN 2023-12-06

Sonosite LX Ultrasound System

Applicant FUJIFILM Sonosite, Inc.

K-Number K233597

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OMP 2023-12-06

Cork Medical VERSA Negative Pressure Wound System (VCMPP-100)

Applicant Cork Medical

K-Number K230677

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DXN 2023-12-05

Electronic Blood Pressure Monitor, model: HTD6602US

Applicant Hetaida Technology Co., Ltd.

K-Number K223170

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PSZ 2023-12-05

BD Veritor™ System for Rapid Detection of Flu A+B CLIA Waived Kit

Applicant Bd

K-Number K232434

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QJF 2023-12-05

Multispectral Imager Kit (MSI Kit) (300-00015), Multispectral Imager (MSI) (300-00009)

Applicant Precision Healing, LLC

K-Number K230734

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HKI 2023-12-05

Optina-4C (MHRC-C1N)

Applicant Optina Diagnostics, Inc.

K-Number K231230

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