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

FBK 2022-08-19

Disposable Endoscope Injection Needle

Applicant Yangzhou Fartley Medical Instrument Technology Co., Ltd.

K-Number K220292

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QJI 2022-08-19

SmartAdjust(TM) technology

Applicant Insulet Corporation

K-Number K220394

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DQX 2022-08-19

Stent Positioning Assistance System (SPAS)

Applicant Seven Sons , Ltd.

K-Number K221917

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NKB 2022-08-19

Cortera Spinal Fixation System

Applicant Surgalign Spine Technologies

K-Number K221403

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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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