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

GCJ 2023-05-10

HandX™ Monopolar Scissors

Applicant Human Xtensions , Ltd.

K-Number K230491

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LLZ 2023-05-10

Neurophet AQUA

Applicant Neurophet., Inc.

K-Number K220437

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FRG 2023-05-09

Tyvek Roll with CI for STERLINK Sterilizer

Applicant Plasmapp Co,., Ltd.

K-Number K223025

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NUH 2023-05-09

Tens & Ems Device

Applicant Shenzhen Jian Feng Electronic Technology Co., Ltd.

K-Number K223825

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MLR 2023-05-09

STERLINK™ FPS-15s Plus sterilizer with STERPACK™ plus cassette

Applicant Plasmapp Co,., Ltd.

K-Number K223015

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LPH 2023-05-09

Latitud™ Hip Replacement System

Applicant Meril Healthcare Pvt. , Ltd.

K-Number K222436

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FRC 2023-05-09

Terragene Bionava SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40)

Applicant Plasmapp Co,., Ltd.

K-Number K223023

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FMF 2023-05-09

Sterile Syringe for Single Use (with Needle), Sterile Hypodermic Needle for Single Use

Applicant Jiangsu Zhiyu Medical Instrument Co, Ltd.

K-Number K212857

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HLL 2023-05-09

Retitrack

Applicant C. Light Technologies, Inc.

K-Number K222484

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PGY 2023-05-09

CX50N

Applicant Wide Corporation

K-Number K222719

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MAX 2023-05-09

SIRION Lateral Lumbar Interbody System

Applicant Astura Medical

K-Number K223335

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PHX 2023-05-09

Catalyst R1 Reverse Shoulder System

Applicant Catalyst Orthoscience, Inc.

K-Number K223655

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