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 2023-07-26

Arm Blood Pressure Monitor, models AOJ-33A and AOJ-33B

Applicant Shenzhen AOJ Medical Technology Co., Ltd.

K-Number K222994

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QFG 2023-07-25

DEKA ACE Pump System

Applicant Deka Research and Development

K-Number K213536

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QIH 2023-07-25

ANDI

Applicant Imeka Solutions, Inc.

K-Number K230913

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FGB 2023-07-25

Uretero1 Single-Use Digital Flexible Ureteroscope (standard deflection), PN UROSD101, Uretero1 Single-Use Digital Flexible Ureteroscope (reverse deflection), PN URORD101, Vision1 Imaging Console and Display System, PN VIS101

Applicant STERIS Corporation

K-Number K231878

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FMI 2023-07-25

EZ-IO Intraosseous Vascular Access System

Applicant Teleflex Medical

K-Number K231924

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IYE 2023-07-25

IDENTIFY

Applicant Varian Medical Systems, Inc.

K-Number K230576

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EBC 2023-07-25

Enamel Coating Resin

Applicant Rizhao Huge Biomaterials Company, Ltd.

K-Number K230455

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DJG 2023-07-25

Emit® II Plus Buprenorphine Assay

Applicant Siemens Healthcare Diagnostics, Inc.

K-Number K221605

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LLZ 2023-07-25

Patient Specific Planning Solution™ 3D Bone Models

Applicant Biomet Manufacturing Corp

K-Number K230540

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IZL 2023-07-25

MOBILETT Impact

Applicant Siemens Medical Solutions

K-Number K231577

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QNP 2023-07-25

ME-APDS™; MAGENTIQ-COLO™

Applicant Magentiq Eye, Ltd.

K-Number K223473

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FMF 2023-07-25

A-TAP (previously called Arthrotap)

Applicant Elcam Medical Acal

K-Number K231900

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