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

FDS 2021-05-13

PENTAX Medical Video Upper GI Scopes (EG Family), PENTAX Medical Video Colonoscopes (EC Family)

Applicant Pentax of America, Inc.

K-Number K210485

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LZA 2021-05-13

Powder Free Nitrile Examination Glove

Applicant Pastel Glove Sdn Bhd

K-Number K210369

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PZH 2021-05-13

A1AT Genotyping Test

Applicant Progenika Biopharma S.A., A Grifols Company

K-Number K211115

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EMA 2021-05-13

Prevest Denpro Dental Cements (Micron Bioactive, Micron Superior, Micron Superior Capsules, Micron Luting, Micron Dentin Conditioner)

Applicant Prevest Denpro Limited

K-Number K200555

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NKB 2021-05-13

Reliance Spinal Screw System

Applicant Reliance Medical Systems, LLC

K-Number K210874

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ODA 2021-05-13

Tablet Application

Applicant Smith & Nephew

K-Number K203566

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KPS 2021-05-12

Symbia VA10A Family

Applicant Siemens Medical Solutions USA, Inc.

K-Number K210557

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QEW 2021-05-12

ClotTriever Thrombectomy System

Applicant Inari Medical, Inc.

K-Number K210689

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JWH 2021-05-12

iTotal® Identity Cruciate Retaining (CR) Knee Replacement System (KRS)

Applicant Conformis, Inc.

K-Number K210809

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MAX 2021-05-12

NuVasive MOD-EX XLIF Interbody System

Applicant Nu Vasive, Incorporated

K-Number K210439

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DXN 2021-05-12

Automatic Arm Electronic Blood Pressure Monitor

Applicant Shenzhen Lepu Intelligent Medical Equipment Co., Ltd.

K-Number K210435

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SBF 2021-05-12

NextAR RSA Platform

Applicant Medacta International S.A.

K-Number K210153

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