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

NEY 2024-09-20

Microwave Ablation Antennas

Applicant Canyon Medical, Inc.

K-Number K241825

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HRS 2024-09-19

Pectus Blu Support Bar System

Applicant Biomet Microfixation

K-Number K241709

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EOB 2024-09-19

MonoStereo

Applicant Medicaltek Co., Ltd.

K-Number K234096

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KPR 2024-09-19

GF85 (models GF85-3P, GF85-SP)

Applicant Samsung Electronics Co., Ltd.

K-Number K242478

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MAX 2024-09-19

HAnano InterFuse(R) Modular Interbody

Applicant Next Orthosurgical

K-Number K242509

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DQD 2024-09-19

Stethophone

Applicant Sparrow Acoustics, Inc.

K-Number K240901

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MUI 2024-09-19

Sterile and Non-Sterile Ultrasonic Coupling Agent

Applicant Anhui Deepblue Medical Technology Co., Ltd.

K-Number K242167

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EGS 2024-09-19

Star E900 Handpiece Series

Applicant Dentalez, Inc., Stardental Division

K-Number K240183

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NUC 2024-09-19

Coconut Hybrid

Applicant Good Clean Love, Inc.

K-Number K242162

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BZR 2024-09-19

Midas Flowmeter; eAVS

Applicant Parker Hannifin Corporation

K-Number K241465

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IYN 2024-09-18

EdgeLife Handheld Wireless Ultrasound System (E8200); EdgeLife Handheld Wireless Ultrasound System (E8220)

Applicant Edgelife Technologies, LLC

K-Number K234153

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DQX 2024-09-18

Arrow® Nitinol Wire

Applicant Teleflex Medical

K-Number K241784

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