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

MBI 2020-11-17

Knotless TensionTight Button Implant System

Applicant Arthrex, Inc.

K-Number K202444

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DWF 2020-11-17

R501 aortic root cannula without vent line, R502 aortic root cannula with vent line

Applicant Sorin Group Italia S.R.L.

K-Number K200612

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GCJ 2020-11-17

Disposable Trocar

Applicant Wuxi Shukang Medical Appliance Co., Ltd.

K-Number K202931

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DZE 2020-11-17

S.I.N. Dental Implant System

Applicant S.I.N. - Sistema DE Implante Nacional S.A.

K-Number K200992

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HRS 2020-11-17

Activ Fuse

Applicant Newclip Technics

K-Number K202307

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QEZ 2020-11-17

JETi AIO Peripheral Thrombectomy System

Applicant Walk Vascular, LLC

K-Number K201998

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NKG 2020-11-16

M.U.S.T. MINI Posterior Cervical Screws System

Applicant Medacta International S.A.

K-Number K203149

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DQK 2020-11-16

Cordiana Dx16

Applicant Cordiana Medical Informatics AG

K-Number K201060

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MRD 2020-11-16

Sientra OPUS Silicone Gel Breast Implant Sizer

Applicant Sientra, Inc.

K-Number K200706

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EOQ 2020-11-16

Ion Endoluminal System

Applicant Intuitive Surgical, Inc.

K-Number K202370

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DZE 2020-11-16

TiUltra Implants and Xeal Abutments

Applicant Nobel Biocare AB

K-Number K202344

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HRS 2020-11-16

EVOS Large Fragment Plating System

Applicant Smith & Nephew, Inc.

K-Number K201918

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