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

DXN 2023-12-05

Electronic Blood Pressure Monitor

Applicant Zhuhai Yueja Medical Device Technology Co., Ltd.

K-Number K232814

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GEI 2023-12-05

Disposable Endoscopic Bipolar

Applicant Jiangsu Hope Biomedical Science & Technology Co., Ltd.

K-Number K231615

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QIH 2023-12-05

Ceevra Reveal 3+

Applicant Ceevra, Inc.

K-Number K233568

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QIH 2023-12-05

Adravision Perio

Applicant Adra Corporation

K-Number K232440

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KDI 2023-12-05

Tablo® Hemodialysis System

Applicant Outset Medical, Inc.

K-Number K233335

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OUR 2023-12-05

Liberty SI Lateral Implant System

Applicant Spinal Simplicity, LLC

K-Number K231923

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FXX 2023-12-05

Aurelia Surgical Mask ASTM Level 1; Aurelia Surgical Mask ASTM Level 2

Applicant Supermax Healthcare Canada-Supermax Medical

K-Number K231005

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FLL 2023-12-05

THERMOCLICK

Applicant T&R BIOFAB CO., Ltd.

K-Number K222057

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NHA 2023-12-05

SS Abutment System

Applicant Osstem Implant Co., Ltd.

K-Number K232220

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MQV 2023-12-05

SIGNAFUSE Bioactive Strip (SBS); SIGNAFUSE Putty

Applicant Bioventus, LLC

K-Number K233490

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QWR 2023-12-04

cobas SARS-CoV-2 Nucleic acid test for use on the cobas Liat System

Applicant Roche Molecular Systems, Inc.

K-Number K223783

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MMI 2023-12-04

Access hsTnI

Applicant Beckman Coulter, Inc.

K-Number K230648

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