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

OTN 2023-06-29

Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System

Applicant Boston Scientific Corporation

K-Number K231549

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DWJ 2023-06-29

HotDog Warming Mattress + Return Electrode

Applicant Augustine Temperature Management, LLC

K-Number K230866

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QPF 2023-06-29

EarliPoint

Applicant Earlitec Diagnostics, Inc.

K-Number K230337

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OCW 2023-06-29

OverStitch NXT Endoscopic Suturing System

Applicant Apollo Endosurgery, Inc.

K-Number K231553

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DXN 2023-06-29

Upper Arm Blood Pressure Monitor

Applicant Shenzhen Yolanda Technology Co., Ltd.

K-Number K230176

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BZD 2023-06-29

F&P 950 Accessory Breathing Circuit Kits

Applicant Fisher & Paykel Healthcare, Ltd.

K-Number K221436

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MOS 2023-06-29

XENOVIEW 3.0T Chest Coil

Applicant Polarean, Inc.

K-Number K231647

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MXK 2023-06-29

MYAH

Applicant Visia Imaging S.R.L.

K-Number K222933

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HAE 2023-06-29

SQ.line KERRISON

Applicant Aesculap, Inc.

K-Number K223596

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GXZ 2023-06-29

Phantom XL Insulated Dilators

Applicant TeDan Surgical Innovations, Inc.

K-Number K231691

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QSY 2023-06-28

Cresilon Hemostatic Gel, CHG, Cresilon Hemostatic Gel (CHG)

Applicant Cresilon, Inc.

K-Number K213652

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DXN 2023-06-28

Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3KVl-5K

Applicant Microlife Intellectual Property GmbH

K-Number K230075

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