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

QDA 2024-08-02

Samsung ECG App v 1.3 (ECG)

Applicant Samsung Electronics Co., Ltd.

K-Number K240909

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NKB 2024-08-02

Cortera Spinal Fixation System

Applicant Xtant Medical Holdings, Inc.

K-Number K241892

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MBI 2024-08-02

Fixone Meniscal Repair

Applicant Aju Pharm Co., Ltd.

K-Number K233601

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IPF 2024-08-02

MYOTouch Muscle Stimulator

Applicant Sunmed, LLC

K-Number K233098

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LZA 2024-08-02

Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (XS,S,M,L,XL,XXL)

Applicant Kanglongda Vietnam Protection Technology Company Limited

K-Number K241970

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HIH 2024-08-02

Single-Use Video Hysteroscope (RP-G-C24, RP-G-C0101)

Applicant Guangzhou Red Pine Medical Instrument Co., Ltd.

K-Number K241987

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PGY 2024-08-02

Coronis OneLook

Applicant Barco N.V.

K-Number K242008

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OLO 2024-08-02

Bendini Cloud Application

Applicant Nuvasive

K-Number K233706

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JSM 2024-08-02

Viral Transport Medium

Applicant Hardy Diagnostics

K-Number K233534

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FYA 2024-08-02

GCI Surgical Gown

Applicant George Courey, Inc.

K-Number K233571

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IRP 2024-08-02

Air compression leg massager

Applicant Huizhou Xinyi Technology Co., Ltd.

K-Number K240981

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BZE 2024-08-02

Thermalite Heated CPAP Tube (CTUBH06H15DS-2, CTUBH15-DS)

Applicant Exceleron Medical

K-Number K241268

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