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

JDQ 2022-10-19

STERN FIX Sternal Stabilization System

Applicant Neos Surgery S.L

K-Number K221795

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GCJ 2022-10-19

RADIANCE ULTRA 32 4K ZEROWIRE DUO

Applicant Nds Surgical Imaging, LLC

K-Number K222890

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KWQ 2022-10-19

Aviator® Anterior Cervical Plating (ACP) System, LITe® Plate System, DynaTran™ Anterior Cervical Plating (ACP) System, Reflex™ Hybrid ACP System, UniVise™ Spinous Process Fixation Plate

Applicant Stryker Corporation

K-Number K221728

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PSQ 2022-10-19

PERI-GUARD Repair Patch, SUPPLE PERI-GUARD Repair Patch

Applicant Synovis Life Technologies, Inc.

K-Number K221029

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PBY 2022-10-19

Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit

Applicant Sirius Medical Systems B.V.

K-Number K222643

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DZE 2022-10-19

Proximerge 2 Dental Implant System

Applicant Quadric Biomed, LLC

K-Number K211409

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BTA 2022-10-19

SOMAVAC 100 Sustained Vacuum System

Applicant Somavac Medical Solutions, Inc.

K-Number K222856

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LYZ 2022-10-19

Disposable Powder Free Vinyl Exam Glove, Black/Blue/Purple

Applicant Ever Global (Vietnam) Enterprise Corporation

K-Number K220992

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PSQ 2022-10-19

Vascu-Guard Vascular Repair Patch

Applicant Synovis Life Technologies, Inc.

K-Number K221032

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HRS 2022-10-18

EVOS Wrist Spanning Plate

Applicant Smith & Nephew, Inc.

K-Number K213123

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QIH 2022-10-18

Spine CAMP™

Applicant Medical Metrics, Inc.

K-Number K221632

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DPS 2022-10-18

MAC 5 A4/ MAC 5 A5/ MAC 5 Lite Resting ECG Analysis System

Applicant Ge Medical Systems Information Technologies, Inc.

K-Number K221321

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