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

NEY 2023-11-13

Disposable Microwave Ablation Needle (T-1408, T-1410, T-1608, T-1610, L-1815, L-1818, L-2015, L-2018)

Applicant Betters(Suzhou) Medical Co., Ltd.

K-Number K232241

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OQY 2023-11-13

ELLAVI UBT

Applicant Sinapi Biomedical (Pty) , Ltd.

K-Number K230849

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KGN 2023-11-13

Foundation Dermal Regeneration Scaffold (DRS) Solo

Applicant Bionova Medical, Inc.

K-Number K231937

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FMK 2023-11-13

Accu-Chek Safe-T-Pro Uno Lancing Device

Applicant Roche Diabetes Care, Inc.

K-Number K232509

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FRO 2023-11-10

Skin and Wound Cleanser

Applicant Winner Medical Co., Ltd.

K-Number K231564

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GWQ 2023-11-09

Neuronaute Plus

Applicant Bioserenity Sas

K-Number K231366

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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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