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

ITI 2023-11-09

Power Wheelchair, W5521

Applicant Zhejiang Innuovo Rehabilitation Devices Co.,Ltd

K-Number K231508

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FBK 2023-11-09

Disposable Endoscope Injection Needles

Applicant Zhejiang Soudon Medical Technology Co., Ltd.

K-Number K232442

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GXN 2023-11-09

Longeviti ClearFit OTS Cranial Implant

Applicant Longeviti Neuro Solutions, LLC

K-Number K231920

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NKG 2023-11-09

SYMPHONY OCT System

Applicant Medos International SARL

K-Number K233366

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DJG 2023-11-09

ARK Hydrocodone Assay

Applicant Ark Diagnostics, Inc.

K-Number K231752

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QHE 2023-11-09

Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner

Applicant Materialise NV

K-Number K233408

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LNH 2023-11-09

MAGNETOM Free.Max; MAGNETOM Free.Star

Applicant Siemens Medical Solutions USA, Inc.

K-Number K231617

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DPS 2023-11-09

Cardio P1

Applicant Bionet Co., Ltd.

K-Number K231150

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EKX 2023-11-09

Dental Handpiece, Wireless Endodontic Handpiece, endoit

Applicant Micro-Nx Co., Ltd.

K-Number K232810

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NBY 2023-11-09

TissueStat

Applicant Durastat, LLC

K-Number K231277

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NGT 2023-11-09

Flush Syringe (Prefilled 0.9% normal saline solution)

Applicant Spm Medicare Pvt. , Ltd.

K-Number K231724

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NDS 2023-11-09

PRIME-XV FreezIS DMSO-Free MD

Applicant Fujifilm Irvine Scientific

K-Number K231804

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