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

JCX 2023-11-03

Easycess Aspiration Pump

Applicant Guangzhou Easycess Medical Co.,Ltd

K-Number K233428

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IPF 2023-11-03

Combo Electrotherapy Device

Applicant Shenzhen Roundwhale Technology Co. , Ltd.

K-Number K231440

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LZA 2023-11-03

Powder Free Nitrile Patient Examination Gloves, Blue Colored, Non Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate

Applicant Better Care Plastic Technology Co., Ltd.

K-Number K232266

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JWH 2023-11-03

TRAX® CR Total Knee System

Applicant Amplitude

K-Number K230078

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DSK 2023-11-03

Endophys Blood Pressure Monitor model BPM-30

Applicant Endophys Technologies, LLC

K-Number K231586

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OHV 2023-11-03

SCIZER (SC1-M410)

Applicant Classys, Inc.

K-Number K230100

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FDF 2023-11-03

GripTract-GI Endoscopic Tissue Manipulator

Applicant Actuated Medical, Inc.

K-Number K231254

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IYN 2023-11-03

LOGIQ e

Applicant Ge Medical Systems Ultrasound and Primary Care Diagnostic,

K-Number K232186

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MBI 2023-11-03

Arthrex FiberTak Suture Anchor

Applicant Arthrex, Inc.

K-Number K232742

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FRN 2023-11-03

Freedom60 Infusion Pump; High-Flo Subcutaneous Needle Sets; Precision Flow Rate Tubing; High-Flo Super26 Subcutaneous Needle Sets; Freedom60 Pre-Filled Syringe Adapter

Applicant Koru Medical Systems

K-Number K231918

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FGB 2023-11-03

Medical Video Endoscope System

Applicant Huger Medical Instrument Co., Ltd.

K-Number K230475

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JXI 2023-11-02

VersaWrap Nerve Protector

Applicant Alafair Biosciences, Inc.

K-Number K232029

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