Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) 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

MAX 2022-10-14

ZSFab Lumbar Interbody System

Applicant Zsfab, Inc.

K-Number K221858

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LLZ 2022-10-14

syngo.via View&GO

Applicant Siemens Healthcare GmbH

K-Number K221501

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GEI 2022-10-14

Voyant Maryland Fusion device with Single-Step Activation (EB212, EB213, EB214)

Applicant Applied Medical Resources Corporation

K-Number K222284

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DYH 2022-10-14

TP Orthodontics Light-Cure Adhesive System, TP Orthodontics Pre-Applied Adhesive, TP Orthodontics Etchant208520

Applicant Tp Orthodontics, Inc.

K-Number K214054

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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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QUA 2022-10-14

The Cooral System

Applicant Braincool AB

K-Number DEN210027

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QPB 2022-10-14

PAL Infiltration System

Applicant Microaire Surgical Instruments, LLC

K-Number K220318

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