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

KDI 2023-12-06

2008T BlueStar Hemodialysis Machine

Applicant Fresenius Medical Care Renal Therapies Group, LLC

K-Number K231125

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MRN 2023-12-06

Evolve Nitric Oxide Delivery System

Applicant Mallinckrodt Manufacturing, LLC

K-Number K222930

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LCP 2023-12-06

Q-Pad Test System

Applicant Qurasense

K-Number K231465

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LZA 2023-12-06

Sterile Nitrile Examination Gloves Powder Free Tested for Use with Chemotherapy Drugs and Fentanyl Citrate

Applicant Shandong Intco Medical Products Co, Ltd.

K-Number K233042

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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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