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

IYN 2022-10-14

X-CUBE 70, X-CUBE 90

Applicant Alpinion Medical Systems Co., Ltd.

K-Number K221093

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LLZ 2022-10-14

Vitrea CT Cardiac Analysis

Applicant Canon Medical Informatics, Inc.

K-Number K222662

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MOS 2022-10-14

16ch Breast Coil / 16ch Breast Coils, 1.5T 16ch Breast Coil, 3.0T 16ch Breast Coil, 1.5T 16ch Breast Coil, 3T 16ch Breast Coil

Applicant Neocoil, LLC

K-Number K222407

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FQH 2022-10-14

BD Surgiphor™ Antimicrobial Irrigation System

Applicant Bd

K-Number K221504

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OVD 2022-10-14

Southern Anterior Screw Fixated Cage (SASCA)

Applicant Southern Medical (Pty) , Ltd.

K-Number K221447

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QKB 2022-10-14

AI-Rad Companion Organs RT

Applicant Siemens Medical Solutions USA, Inc.

K-Number K221305

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QPB 2022-10-14

PAL Infiltration System

Applicant Microaire Surgical Instruments, LLC

K-Number K220318

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PJA 2022-10-14

HeartFlow Analysis

Applicant HeartFlow, Inc.

K-Number K213857

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PHX 2022-10-14

Tornier Perform Humeral System – Fracture

Applicant Tornier, Inc.

K-Number K220914

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JXG 2022-10-14

Hakim Programmable Valves, Hakim Precision Fixed Pressure Valves

Applicant Integra Lifesciences Production Corporation

K-Number K221840

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FMI 2022-10-14

Safety Insulin Pen Needles

Applicant Zhejiang Kindly Medical Devices Co., Ltd.

K-Number K213183

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MAX 2022-10-14

FOCUS Interbody System

Applicant Oc Medical Devices

K-Number K221172

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