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

FRG 2019-01-03

Safe Secure Sterilization Pouches and Rolls

Applicant Safe Secure Packing Co., Ltd.

K-Number K180139

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KCT 2019-01-03

PRO-LITE Sterilization Tray

Applicant STERIS Corporation

K-Number K183301

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MLR 2019-01-03

V-PRO s2 Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization System

Applicant STERIS Corporation

K-Number K182568

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MMK 2019-01-03

Maxcon Sharps Container

Applicant Ningbo Maxcon Medical Technology Co., Ltd.

K-Number K180984

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MBI 2019-01-03

Responsive Arthroscopy Suture Anchor System

Applicant Responsive Arthroscopy, LLC

K-Number K180951

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DXN 2019-01-03

Arm Blood Pressure Monitor

Applicant Alicn Medical (Shenzhen), Inc.

K-Number K180435

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PKT 2019-01-03

SculpSure

Applicant Cynosure

K-Number K182741

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KWQ 2019-01-03

Raven Lumbar Plate System

Applicant Choicespine, LP

K-Number K183214

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MMK 2019-01-03

Maxcon Two Gallon Chemotherapy Container

Applicant Ningbo Maxcon Medical Technology Co., Ltd.

K-Number K180983

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NXC 2019-01-03

Clear Image Aligners

Applicant Specialty Appliance Works, Inc.

K-Number K183643

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FRC 2019-01-03

VERIFY V24 Self-Contained Biological Indicator, VERIFY V24 Biological Indicator Challenge Pack

Applicant Steris Corporations

K-Number K183300

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FRG 2019-01-03

Vis-U-All Low Temperature Sterilization Pouch/Tubing

Applicant STERIS Corporation

K-Number K183297

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