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

ITI 2023-12-13

Power Wheelchair (N5909)

Applicant Zhejiang Innuovo Rehabilitation Devices Co.,Ltd

K-Number K230964

View Details →

QIH 2023-12-13

QP-Brain®

Applicant Quibim S.L.

K-Number K232231

View Details →

FTC 2023-12-13

DT Controlled Phototherapy Equipment

Applicant Daavlin Distributing Co.

K-Number K233811

View Details →

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

View Details →

OVE 2023-12-13

Genesys Spine 3DP AIS-C II Cervical Interbody System

Applicant Genesys Spine

K-Number K233594

View Details →

GGP 2023-12-13

HemosIL Chromogenic Factor IX

Applicant Instrumentation Laboratory Company

K-Number K230852

View Details →

PHL 2023-12-13

Atalante X

Applicant Wandercraft SAS

K-Number K232077

View Details →

PNZ 2023-12-13

ACCLARENT AERA Eustachian Tube Dilation System

Applicant Acclarent, Inc.

K-Number K230742

View Details →

HRS 2023-12-13

Anatomical Plating System (various)

Applicant Tyber Medical, LLC

K-Number K232652

View Details →

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

View Details →

OBP 2023-12-13

NeuroStar Advanced Therapy System (Version 3.8)

Applicant Neuronetics

K-Number K233621

View Details →

PHZ 2023-12-13

Tyto Insights for Wheeze Detection

Applicant Tyto Care , Ltd.

K-Number K232237

View Details →

Page 647 of 2685

↑