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

DQO 2023-06-01

Drakon™ and Sequre® Microcatheters

Applicant Accurate Medical Therapeutics

K-Number K231293

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MHX 2023-06-01

Radius VSM and Accessories

Applicant Masimo Corporation

K-Number K223498

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QQX 2023-06-01

cobas SARS-CoV-2 Qualitative for use on the cobas 5800/6800/8800 Systems

Applicant Roche Molecular Systems, Inc.

K-Number K231306

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EOQ 2023-06-01

Ambu® aScope™ 5 Broncho HD 5.0/2.2, Ambu® aScope™ 5 Broncho HD 5.6/2.8, Ambu® aView™ 2 Advance

Applicant Ambu A/S

K-Number K223299

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FXX 2023-06-01

Surgical Face Mask (L 175*95mm)

Applicant Henan Chaoya Medical Equipment Co., Ltd.

K-Number K230617

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QEW 2023-06-01

Laguna™ Clot Retriever System and Malibu™ Aspiration Catheter System (Laguna Thrombectomy System)

Applicant Innova Vascular, Inc.

K-Number K223929

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OWB 2023-06-01

ANT-X System

Applicant Ndr Medical Technology Pte. , Ltd.

K-Number K230185

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MMK 2023-06-01

Maxcon Sharps Container (1 QT Sharps Container, MA1112), Maxcon Sharps Container (5.4 QT Sharps Container, MA1212), Maxcon Sharps Container (5.4 QT Sharps Container, MA1213), Maxcon Sharps Container (7 Liter Sharps Container, MA1324)

Applicant Ningbo Maxcon Medical Technology Co., Ltd.

K-Number K222905

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GEI 2023-05-31

BTL-785X

Applicant BTL Industries, Inc.

K-Number K222556

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QNQ 2023-05-31

FEELject LDV (Low dead volume) syringe

Applicant Feeltech Co., Ltd.

K-Number K213010

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NLH 2023-05-31

Medline ReNewal Reprocessed St. Jude Medical Livewire Steerable Electrophysiology Catheter

Applicant Surgical Instrument Service and Savings, Inc.

K-Number K221067

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MAI 2023-05-31

Fix2Lock(Biocomposite medial, lateral, Biocombi Self Punching)

Applicant Osteonic Co., Ltd.

K-Number K231326

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