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

LLZ 2023-07-14

CommandEP Data Manager PC (DPC02), CommandEP HMD (HMD02)

Applicant Sentiar, Inc.

K-Number K223290

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LLZ 2023-07-14

Cercare Medical Neurosuite

Applicant Cercare Medical A/S

K-Number K230016

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DQX 2023-07-14

TalWire

Applicant Embrace Medical , Ltd.

K-Number K223791

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OUR 2023-07-14

PathLoc SI Joint Fusion System

Applicant L&K BIOMED Co., Ltd.

K-Number K231841

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QIH 2023-07-14

Brainlab Elements Image Fusion, Contouring (4.5);Image Fusion (4.5);Fibertracking (2.0);BOLD MRI Mapping (1.0);Image Fusion Angio (1.0)

Applicant Brainlab AG

K-Number K223106

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QWL 2023-07-14

Ruthless Spine RJB

Applicant Ruthless, LLC Dba Ruthless Spine

K-Number DEN230012

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HGX 2023-07-14

Wearable Breast Pump (Model S18)

Applicant Shenzhen TPH Technology Co., Ltd.

K-Number K223886

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INI 2023-07-14

Mobility Scooter (Models: W3431D)

Applicant Zhejiang Innuovo Rehabilitation Devices Co.,Ltd

K-Number K231428

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QIH 2023-07-14

Ez3D-i /E3

Applicant Ewoosoft Co., Ltd.

K-Number K231757

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EBI 2023-07-14

OnX Tough

Applicant Sprintray, Inc.

K-Number K230445

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NHA 2023-07-14

Neodent Implant System - Zirconia Implant System

Applicant Jjgc Industria E Comercio DE Materiais Dentarios S.A.

K-Number K222026

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CAC 2023-07-14

FlowSaver Blood Return System (80-101)

Applicant Inari Medical, Inc.

K-Number K231782

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