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

PNR 2021-06-28

ENFit Disposable Enteral Syringe

Applicant Shantou Wealy Medical Instrument Co.,Ltd

K-Number K203410

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EBF 2021-06-28

Diafil & Diafil Capsule

Applicant DiaDent Group International

K-Number K210421

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HSB 2021-06-28

Phantom Hindfoot TTC/TC Nail System

Applicant Paragon 28, Inc.

K-Number K210869

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DZJ 2021-06-28

CenterMed Patient Matched Assisted Surgical Planning (ASP) System

Applicant Centermed, Inc.

K-Number K201353

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LZA 2021-06-28

Violet Nitrile Powder Free Patient Examination Glove, Non Sterile

Applicant Onetexx Sdn Bhd

K-Number K210587

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INI 2021-06-25

Scooter (Model: FDB01)

Applicant Nanjing Jin Bai HE Medical Apparatus Co., Ltd.

K-Number K201196

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NDN 2021-06-25

SpineJack Expansion Kit, Vertaplex Radiopaque Bone Cement, Vertaplex HV Radiopaque Bone Cement

Applicant Stryker Instruments

K-Number K211238

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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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