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

IYN 2021-06-25

Vu-Path Ultrasound System

Applicant Crystalline Medical

K-Number K203657

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LZA 2021-06-25

Nitrile Glove

Applicant Jiangsu Dihong Industry and Trade Co., Ltd.

K-Number K211252

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LLZ 2021-06-25

3D Echo v1.1

Applicant Jointvue, LLC

K-Number K211656

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QAU 2021-06-25

PuraStat-GI

Applicant 3-D Matrix, Inc.

K-Number K210098

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JXO 2021-06-25

Psychemedics Homogeneous Enzyme Immunoassay for Cocaine in Hair

Applicant Psychemedics Corporation

K-Number K201228

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IYN 2021-06-25

Apache Ultrasound System

Applicant Aco Healthcare Co., Ltd.

K-Number K211232

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QKA 2021-06-25

iTind System

Applicant Medi-Tate , Ltd.

K-Number K210138

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FMI 2021-06-25

Safety Winged Blood Collection Sets

Applicant Promisemed Hangzhou Meditech Co., Ltd.

K-Number K211293

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IYO 2021-06-25

BD Prevue II Peripheral Vascular Vascular Access System

Applicant Bard Access Systems, Inc. (C.R. Bard, Inc.)

K-Number K211193

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DQK 2021-06-25

iLab Polaris Multi-Modality Guidance System

Applicant Boston Scientific Corporation

K-Number K210889

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IYO 2021-06-24

THD Procto Software System

Applicant Thd Spa

K-Number K211623

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GEI 2021-06-24

Werewolf+ Coblation System, Werewolf+ Controller, Werewolf Fastseal 6.0 Hemostasis Wand

Applicant ArthroCare Corporation

K-Number K210423

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