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

OLO 2023-10-06

Invictus Robotic Navigation Instruments

Applicant Alphatec Spine, Inc.

K-Number K232044

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JTN 2023-10-06

Thermo Scientific Oxoid Sulbactam/Durlobactam Disc (10/10 µg) SUD20

Applicant Oxoid Limited (Part of Thermo Fisher Scientific)

K-Number K232276

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LZA 2023-10-06

Patient Examination Gloves

Applicant 3A Glove Sdn. Bhd.

K-Number K230777

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QUO 2023-10-06

Vivio® LVEDP System

Applicant Avicena, LLC

K-Number K223905

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MYN 2023-10-06

Denti.AI Detect

Applicant Denti.Ai Technology, Inc.

K-Number K230144

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MBI 2023-10-06

JuggerKnot Soft Anchor OC

Applicant Riverpoint Medical, LLC

K-Number K232411

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ETN 2023-10-06

EARP Nerve Cuff Electrode

Applicant Nvision Biomedical Technologies, Inc.

K-Number K230853

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LHN 2023-10-06

ProBeam 360° Proton Therapy System v2.0 (Multiroom)

Applicant Varian Medical Systems, Inc.

K-Number K231863

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OHT 2023-10-06

IPL Hair Removal Device, Model(s): PB1, PB2, PB3, PB4, TM002

Applicant Dongguan Lide Electric Appliance Co., Ltd.

K-Number K232056

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MYN 2023-10-05

DeepTek CXR Analyzer v1.0

Applicant Deeptek Medical Imaging Pvt, Ltd.

K-Number K231001

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HIS 2023-10-05

LifeStyles NRL Textured Condom

Applicant Suretex Limited

K-Number K232279

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KPI 2023-10-05

MFG-05

Applicant Zimmer Medizinsysteme GmbH

K-Number K230780

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