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

FRC 2024-06-27

3M™ Attest™ Rapid Readout Biological Indicator 1295 and 3M™ Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E

Applicant 3M Company

K-Number K240717

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HRS 2024-06-26

Forma Medical Optimal Plating System

Applicant Forma Medical, Inc.

K-Number K234059

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LNH 2024-06-26

Magnifico Open (100009900); Magnifico MSK ( 100009910)

Applicant Esaote, S.p.A.

K-Number K241133

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JWH 2024-06-26

Unity Knee PS-C Tibial Insert

Applicant Corin U.S.A. Limited

K-Number K240875

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DTK 2024-06-26

ALN Optional Vena Cava Filter (FB.010500, FF.010995, FJ.120096, FB.HOOK, FF.HOOK, FJ.HOOK)

Applicant Aln S.A.R.L.

K-Number K241507

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JAA 2024-06-26

TRIDENT Mobile Fluoroscopy System

Applicant Dornier Medtech America

K-Number K233380

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QBD 2024-06-26

Sample Preservative Fluid

Applicant Hangzhou Bioer Technology Co., Ltd.

K-Number K222771

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MWI 2024-06-26

WVSM Pro (Series) (500-0030-XX)

Applicant Athena Gtx, Inc.

K-Number K233354

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IYO 2024-06-26

SC1 Handheld Ultrasound Imaging system (Model: SC1)

Applicant Fcu Co., Ltd.

K-Number K233579

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HRS 2024-06-26

Versalock Rib and Sternum Plates System

Applicant GM Dos Reis Industria e Comercio Ltda.

K-Number K232829

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JOJ 2024-06-26

Ultraphon Chemical Indicator (TRO-T and TRO-B)

Applicant True Indicating, LLC

K-Number K233413

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LHI 2024-06-26

FlowArt Valve for Vial Access

Applicant Asset Medikal Tasarim Sanayi VE Ticaret A.S.

K-Number K232987

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