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

FMI 2023-09-08

Sterile Safety Hypodermic Needles for Single Use

Applicant Wepon Medical Technology Co., Ltd.

K-Number K231723

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FMF 2023-09-08

Sterile Auto-Disable Syringes with/without Needle for Single Use

Applicant Wepon Medical Technology Co., Ltd.

K-Number K231727

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QLY 2023-09-08

VitreJect Syringe

Applicant Ocuject, LLC

K-Number K230372

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MUJ 2023-09-08

VariSeed (v10)

Applicant Varian Medical Systems

K-Number K232400

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OLO 2023-09-08

Fusion Robotic Navigation System

Applicant Alphatec Spine, Inc.

K-Number K232413

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MBH 2023-09-08

Identity Imprint Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate Sacrificing (CS) Inserts

Applicant Conformis, Inc.

K-Number K232426

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FMI 2023-09-08

Sterile syringes for single use with/without needle

Applicant Wepon Medical Technology Co., Ltd.

K-Number K231729

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OCW 2023-09-08

MaxTack Motorized Fixation Device

Applicant Covidien

K-Number K231240

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NQQ 2023-09-08

ILUMIEN OPTIS System, OPTIS Integrated System, OPTIS Mobile System, with AptiVue Imaging Software version E.6

Applicant ABBOTT MEDICAL

K-Number K232386

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QXZ 2023-09-08

Cleerly ISCHEMIA

Applicant Cleerly, Inc.

K-Number K231335

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LZA 2023-09-08

Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue)

Applicant Syntex Healthcare Products Co., Ltd.

K-Number K231643

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QXX 2023-09-08

CorVista® System

Applicant Corvista Health, Inc.

K-Number K232686

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