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

HRS 2020-10-26

AOS Fibonacci Lower Extremity Plating System AOS Proximal Tibia Plating System

Applicant Advanced Orthopaedic Solutions, Inc.

K-Number K202489

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NUH 2020-10-24

Li-Battery powered OTC TENS/EMS Combination Stimulator

Applicant Everyway Medical Instruments Co.,Ltd

K-Number K201335

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MUE 2020-10-23

Planmed Clarity 2D and Clarity S

Applicant Planmed OY

K-Number K192317

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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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