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

DQO 2020-10-23

Drakon and Sequre Microcatheters

Applicant Accurate Medical Therapeutics, Ltd.

K-Number K202797

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DTZ 2020-10-23

OXY-1 System

Applicant Abiomed, Inc.

K-Number K200109

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OMP 2020-10-23

PocketDoc™ Micro Wound Therapy System

Applicant Pensar Medical, LLC

K-Number K200223

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KJJ 2020-10-23

V-Mix

Applicant Inter-Med/Vista Dental Products

K-Number K193357

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JWH 2020-10-23

Mobio Total Knee System

Applicant B-One Ortho, Corp.

K-Number K202429

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FQH 2020-10-23

SURGIPHOR Wound Irrigation System

Applicant Orthophor, LLC

K-Number K202071

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HIH 2020-10-23

BenestaTM Tissue Removal Device

Applicant Caldera Medical, Inc.

K-Number K192811

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NKB 2020-10-23

Wiltrom Spinal Fixation System

Applicant Wiltrom Corporation Limited

K-Number K202894

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FPA 2020-10-23

MaxZero Extension Sets with Needle-Free Connector(s)

Applicant Carefusion, Inc.

K-Number K193088

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KPS 2020-10-23

SIR-Spheres Microspheres Activity Calculator (SMAC)

Applicant Sirtex Medical US Holdings, Inc.

K-Number K202392

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GFO 2020-10-23

Cryocheck Hex LA

Applicant Precision Biologic

K-Number K193556

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FLL 2020-10-23

Infrared ear and forehead thermometer, model YI-100

Applicant Wenzhou Yosun Medical Technology Co.,Ltd

K-Number K201843

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