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

NKG 2020-06-15

Centurion POCT System

Applicant Orthofix, Inc.

K-Number K201481

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FTM 2020-06-15

CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large), CanGaroo Envelope (extra large), CanGaroo Enevlope (extra extra large) (SubQ)

Applicant Aziyo Biologics, Inc.

K-Number K201313

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OVE 2020-06-15

F3D Cervical Stand-Alone Interbody Fusion System

Applicant Corelink, LLC

K-Number K200087

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DWJ 2020-06-13

STERIS Patient Warming System

Applicant STERIS Corporation

K-Number K200446

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MWP 2020-06-12

Kubtec Mozart Supra

Applicant Kub Technologies, Inc.

K-Number K200756

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QLG 2020-06-12

FreeStyle Libre 2 Flash Glucose Monitoring System

Applicant Abbott Diabetes Care, Inc.

K-Number K193371

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GKR 2020-06-12

Hemo Control (optional Add Pack Hemo Control DM)

Applicant Ekf-Diagnostic GmbH

K-Number K200909

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DRE 2020-06-12

ExpanSure Large Access Transseptal Dilator

Applicant Baylis Medical Company, Inc.

K-Number K201288

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MUE 2020-06-12

MAMMOMAT Revelation

Applicant Siemens Medical Solutions USA, Inc.

K-Number K193166

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DXN 2020-06-12

Full Automatic(NIBP) Blood Pressure Monitor

Applicant Health & Life Co., Ltd.

K-Number K200521

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DXE 2020-06-12

Fogarty Arterial Embolectomy Catheter, Fogarty Biliary Balloon Probe

Applicant Edwards Lifesciences, LLC

K-Number K193379

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DTZ 2020-06-12

INSPIRE 7FM Hollow fiber oxygenator with integrated arterial filter, INSPIRE 7F Hollow fiber oxygenator with integrated arterial filter and hardshell reservoir, INSPIRE 7F DUAL Hollow fiber oxygenator with integrated arterial filter and hardshell reservoir

Applicant Sorin Group Italia S.R.L.

K-Number K200683

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