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

NFO 2024-12-13

BTL-785BNF-E

Applicant BTL Industries, Inc.

K-Number K242532

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CBK 2024-12-13

731 Series Ventilator

Applicant ZOLL Medical Corporation

K-Number K233486

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ETN 2024-12-13

Bioscope Neuromonitor Device

Applicant Biosys Biyomedikal Muhendislik San. VE Tic. A.S.

K-Number K233001

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GCJ 2024-12-13

LCD Monitor (MDEC-2523)

Applicant Barco N.V.

K-Number K243307

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NXC 2024-12-12

GENIOVA aligners

Applicant Geniova Technologies Sociedad Limitada

K-Number K233152

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IYN 2024-12-12

EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System

Applicant Philips Ultrasound, LLC

K-Number K242020

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KNS 2024-12-12

Aqua Medical RF Vapor Ablation System

Applicant Aqua Medical, Inc.

K-Number K241271

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KIF 2024-12-12

Bioceramic Root Canal Sealer and Repair Materials (i-MTA BP)

Applicant Longly Biotechnology (Wuhan) Co., Ltd.

K-Number K242934

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EBD 2024-12-12

visio.lign color, visio.lign shield

Applicant Bredent GmbH & Co. KG

K-Number K240735

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FRC 2024-12-12

Terragene® Bionova® Photon Process Challenge Device with unique-point integrator (PCD225-2);Terragene® Bionova® Photon Process Challenge Device with moving-front integrator (PCD225-C)

Applicant Terragene S.A.

K-Number K242453

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FZE 2024-12-12

Medicon Epiplating System

Applicant Cmf Medicon Surgical, Inc.

K-Number K241253

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OPT 2024-12-12

Infrascanner Model 2500 (Model 2500)

Applicant Infrascan, Inc.

K-Number K241389

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