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

JDR 2023-08-30

StealthFix Intraosseous Fixation System

Applicant Medartis, Inc.

K-Number K232324

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PLQ 2023-08-30

Enzyme Packed Cartridge - RELiZORB

Applicant Alcresta Therapeutics, Inc.

K-Number K231156

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LLZ 2023-08-30

Brainomix 360 e-MRI

Applicant Brainomix Limited

K-Number K231656

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DSI 2023-08-30

SmartCardia 7L Platform

Applicant Smartcardia SA

K-Number K231276

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DXQ 2023-08-30

NIBPCuff

Applicant Shenzhen Sino-K Medical Technology Co.,Ltd

K-Number K231961

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BSO 2023-08-30

Arrow Non-Stimulating SnapLock Adapter (K-05520-005C); Arrow Non-Stimulating Next Gen SnapLock Adapter (Luer Connection) (CA-000010-19); Arrow Non-Stimulating Next Gen SnapLock Adapter (Neuraxial Connection) (CA-000014-19); Arrow Stimulating SnapLock Adapter (with cable) (TZ-02060-001); Arrow Stimulating SnapLock Adapter (with tab) (TZ-05000-002)

Applicant Teleflex Medical

K-Number K230603

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PAY 2023-08-30

Silk'n Titan Allways

Applicant Silk'N Beauty , Ltd.

K-Number K230013

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MBI 2023-08-30

AlphaVent Suture Anchors

Applicant Stryker Endoscopy

K-Number K231093

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DSP 2023-08-30

AC3™ Series IABP

Applicant Arrow International, LLC

K-Number K232343

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LNH 2023-08-30

Vantage Galan 3T, MRT-3020, V9.0 with AiCE Reconstruction Processing Unit for MR

Applicant Canon Medical Systems Corporation

K-Number K230355

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JWY 2023-08-30

Sensititre 20-24-hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Dalbavancin in the dilution range of 0.0005-2µg/ml

Applicant Thermo Fisher Scientific

K-Number K231988

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BTR 2023-08-30

Shiley™ Pediatric Oral/Nasal Endotracheal Tube with TaperGuard™ Cuff, Non DEHP (86125, 86130, 86135, 86140, 86145, 86150, 86155, 86160)

Applicant Covidien

K-Number K223130

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