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

KPS 2020-02-14

Biograph Vision, Biograph mCT Family of PET/CTs

Applicant Siemens Medical Solutions USA, Inc.

K-Number K193248

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GYC 2020-02-14

Blackrock NeuroCoG Subdural Cortical Electrodes (Strips and Grids)

Applicant Blackrock Microsystems

K-Number K191346

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OLY 2020-02-14

Orion LifeSpan MEG

Applicant Compumedics Limited

K-Number K191785

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MBI 2020-02-14

Dunamis PunchTac Suture Anchors

Applicant Dunamis, LLC

K-Number K193245

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LLZ 2020-02-14

Vitrea Software Package

Applicant Canon Medical Systems Corporation

K-Number K192923

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LON 2020-02-14

VITEK 2 AST- Gram Negative Polymyxin B (<=0.25 >=16 ug/mL)

Applicant bioMerieux, Inc.

K-Number K193567

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NBW 2020-02-14

OneTouch Verio Reflect Blood Glucose Monitoring System

Applicant Lifescan Europe GmbH

K-Number K193475

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KPS 2020-02-14

Affinity

Applicant Hermes Medical Solutions AB

K-Number K193152

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OLO 2020-02-14

Real Intelligence Cori

Applicant Blue Belt Technologies, Inc.

K-Number K193120

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JFP 2020-02-14

i-STAT CHEM8+ cartridge with the i-STAT 1 System

Applicant Abbott Point of Care, Inc.

K-Number K191360

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NPM 2020-02-14

The Graft Bone Substitute

Applicant Purgo Biologics, Inc.

K-Number K191737

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NHJ 2020-02-14

Maximus System

Applicant Hill-Rom Services Pte, Ltd.

K-Number K192143

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