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

NEU 2020-12-16

HydroMARK Breast Biopsy Site Markers

Applicant Devicor Medical Products, Inc.

K-Number K203097

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JDR 2020-12-16

Arthrex DynaNite Nitinol Staples

Applicant Arthrex, Inc.

K-Number K203180

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FXX 2020-12-16

Medical Surgical Mask

Applicant Beijing Biosis Healing Biolog Ical Technology Co., Ltd.

K-Number K202029

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ILY 2020-12-16

dermalux Flex MD

Applicant Aesthetic Technology, Ltd.

K-Number K202028

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KWS 2020-12-16

ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA)

Applicant Stryker GmbH

K-Number K202289

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ODP 2020-12-16

Lucero Medical Cervical Cage System

Applicant Lucero Medical, LLC

K-Number K200549

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NHA 2020-12-16

CreoDent Solidex Customized Abutment and Screw

Applicant Creodent Prosthetics, Ltd.

K-Number K202095

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HWC 2020-12-16

CREED™ Cannulated Screws

Applicant Glw Medical, Inc.

K-Number K200291

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MQK 2020-12-16

Pasteur Pipette 3mL, Pasteur Pipette 1mL

Applicant Hertart Aps

K-Number K201213

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LQR 2020-12-16

Disposable Stone Extraction basket

Applicant Hangzhou AGS MedTech Co., Ltd.

K-Number K201509

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GXN 2020-12-16

Longeviti ClearFit Cranial Implant

Applicant Longeviti Neuro Solutions, LLC

K-Number K203349

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MAX 2020-12-15

WaveForm L Interbody System, WaveForm TO Interbody System, WaveForm TA Interbody System

Applicant SeaSpine Orthopedics Corporation

K-Number K201755

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