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

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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MED 2021-05-12

SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900, S40 Sterilant Concentrate

Applicant STERIS Corporation

K-Number K210737

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FRO 2021-05-12

High Performance Antimicrobial Gelling Fiber with Silver

Applicant Advanced Medical Solutions, Ltd.

K-Number K210974

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IRP 2021-05-11

Air Pressure Therapy System: VU-IPC06

Applicant Xiamen Weiyou Intelligent Technology Co., Ltd.

K-Number K210967

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IPF 2021-05-11

Neurodyn V2.0, Neurodyn Aussie V2.0

Applicant Ibramed Equipamentos Medicos

K-Number K210572

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EWY 2021-05-11

HD Mediastinoscope

Applicant Karl Storz Endoscopy America, Inc.

K-Number K202272

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HQD 2021-05-11

Valley Contax Single Vision (SV) Gas Permeable Contact Lens (roflufocon D, roflufocon E, tisilfocon A, hexafocon A, enflufocon A), Valley Contax Goldeneye Aspheric Front Multifocal (AFM) Gas Permeable Contact Lens (roflufocon D, roflufocon E, tisilfocon A, hexafocon A, enflufocon A), Valley Contax V Kone (VK) Gas Permeable Contact Lens (roflufocon D, roflufocon E, tisilfocon A, hexafocon A, enflufocon A)

Applicant Valley Contax, Inc.

K-Number K202860

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FGE 2021-05-11

HANAROSTENT Benefit Biliary (NNN)

Applicant M.I.Tech Co., Ltd.

K-Number K202973

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