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

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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PTE 2019-01-03

EndoRotor Console, EndoRotor Catheters, EndoRotor Specimen Trap, EndoRotor Filter Set, EndoRotor Foot Control

Applicant Interscope, Inc.

K-Number K181127

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JAK 2019-01-03

uCT 520, uCT 528

Applicant Shangai United Imaging Healthcare Co., Ltd.

K-Number K183143

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HKI 2019-01-02

NFC-700 non-mydriatic auto fundus camera

Applicant Crystalvue Medical Corporation

K-Number K182199

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LLZ 2019-01-02

ProKnow DS

Applicant Proknow, LLC

K-Number K182855

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