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FDA 510(k) Clearances

510(k) cleared devices tracked by MedTracker

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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HWC 2021-05-11

DART-FIRE EDGE Cannulated Screw System

Applicant Wright Medical

K-Number K203228

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GEX 2021-05-10

Diode Laser Therapy Systems

Applicant Beijing Kes Biology Technology Co., Ltd.

K-Number K210168

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JFY 2021-05-10

Yumizen C1200 Creatinine PAP

Applicant HORIBA ABX SAS

K-Number K193649

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INI 2021-05-10

Solax Electric Scooter (Models: S204311M, S204161, S204143)

Applicant Dongguan Prestige Sporting Goods Co., Ltd.

K-Number K190737

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EKX 2021-05-10

Endo Motor

Applicant Guilin Woodpecker Medical Instrument Co., Ltd.

K-Number K203320

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