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

MRW 2023-12-13

FaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex Interspinous Fixation System, and AEON-C™ Stand Alone System

Applicant K&J Consulting Corporation

K-Number K232877

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OVE 2023-12-13

Genesys Spine 3DP AIS-C II Cervical Interbody System

Applicant Genesys Spine

K-Number K233594

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GGP 2023-12-13

HemosIL Chromogenic Factor IX

Applicant Instrumentation Laboratory Company

K-Number K230852

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PHL 2023-12-13

Atalante X

Applicant Wandercraft SAS

K-Number K232077

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PNZ 2023-12-13

ACCLARENT AERA Eustachian Tube Dilation System

Applicant Acclarent, Inc.

K-Number K230742

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HRS 2023-12-13

Anatomical Plating System (various)

Applicant Tyber Medical, LLC

K-Number K232652

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DJG 2023-12-13

Dochek® Multi-Drug Urine Test Cup Rx, Dochek® Multi-Drug Urine Test Cup

Applicant Guangzhou Decheng Biotechnology Co., Ltd.

K-Number K232659

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OBP 2023-12-13

NeuroStar Advanced Therapy System (Version 3.8)

Applicant Neuronetics

K-Number K233621

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PHZ 2023-12-13

Tyto Insights for Wheeze Detection

Applicant Tyto Care , Ltd.

K-Number K232237

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QFT 2023-12-13

EndeavorRx

Applicant Akili Interactive Labs, Inc.

K-Number K231337

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LNH 2023-12-13

fMRI Hardware System

Applicant Nordicneurolab AS

K-Number K232680

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NHA 2023-12-13

Neodent Implant System - Zirconia Implant System

Applicant JJGC Indústria e Comércio de Materiais Dentários S.A.

K-Number K231803

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