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

FXX 2022-08-19

CAREWE Surgical Face Mask Models N001-AW, N002-AW, and N003-AW

Applicant Huizhou Tianchang Industrial Co., Ltd.

K-Number K203078

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DQK 2022-08-18

EnSite X EP System

Applicant Abbott

K-Number K221213

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MEG 2022-08-18

Jeesung Safety Syringe and Single Use Needles

Applicant Jeesung Medical Co., Ltd.

K-Number K212518

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BTM 2022-08-18

Sotair Device

Applicant Safe Bvm Corporation

K-Number K212905

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QJP 2022-08-18

Benchmark BMX96 Access System

Applicant Penumbra, Inc.

K-Number K213390

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LPH 2022-08-18

OR3O Dual Mobility System

Applicant Smith & Nephew, Inc.

K-Number K220959

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DWF 2022-08-18

Quantum Perfusion Dual Lumen Cannula 31F, Quantum Perfusion Dual Lumen Cannula 27F, Quantum Perfusion Dual Lumen Cannula 24F, Quantum Perfusion Dual Lumen Cannula 29F, Quantum Perfusion Dual Lumen Cannula 24F-V1, Quantum Perfusion Dual Lumen Cannula 27F-V1, Quantum Perfusion Dual Lumen Cannula 29F-V1, Quantum Perfusion Dual Lumen Cannula 27F-VS, Quantum Perfusion Dual Lumen Cannula 31F-VS

Applicant Qura S.R.L

K-Number K221353

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DQY 2022-08-18

GuideLiner Coast, 5.5F (5270); GuideLiner Coast, 6F (5271); GuideLiner Coast, 7F (5272); GuideLiner Coast, 8F (5273)

Applicant Vascular Solutions, LLC

K-Number K220647

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KGN 2022-08-18

Miro3D Wound Matrix

Applicant Reprise Biomedical, Inc.

K-Number K221520

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JSM 2022-08-18

iClean Viral Transport System (VTM-RT kit)

Applicant Huachenyang (Shenzhen) Technology Co. , Ltd.

K-Number K212856

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NPK 2022-08-18

Bio-MEM Ti Reinforced Membrane

Applicant B&Medi Co., Ltd.

K-Number K210797

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GEH 2022-08-18

truFreeze Console, PN CC301; Aire PV Passive Venting Catheter, PN CO840703; 16 Fr CDT 5 Pack, PN 2000181; 20Fr CDT 5 Pack, PN ACCCC3CDT05; Active Venting Spray Kit, 20 Fr CDT, PN 2000177; Active Venting Spray Kit 16 Fr CDT, PN 20000516; Rapid AV Catheter 5 Pack, PN 2000184

Applicant STERIS Corporation

K-Number K222272

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