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

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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KPR 2023-11-02

XVISION-525, HORIZON, HI-300, HI-500, SATURN-F PF32, SATURN-F PF40, SATURN-F PF50

Applicant GEMSS HEALTHCARE CO., LTD.

K-Number K230800

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OLO 2023-11-02

ATEC Posterior Navigated Disc Prep Instruments

Applicant Alphatec Spine, Inc.

K-Number K232345

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NFT 2023-11-02

BioSieveTM Multi-Drug Urine Test Panel; BioSieveTM Multi-Drug Urine Test Panel Rx

Applicant Vivachek Biotech (Hangzhou) Co., Ltd.

K-Number K233062

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EBZ 2023-11-02

BASE290 LED Curing Light

Applicant Handpiece Headquarters

K-Number K233518

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