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

MOF 2020-04-16

Traxcess 14 SELECT Guidewire

Applicant MicroVention, Inc.

K-Number K200547

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HRY 2020-04-16

SIGMA High Performance (HP) Partial Knee System

Applicant Depuy Ireland UC

K-Number K193549

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OWB 2020-04-16

ARTIS Icono

Applicant Siemens Medical Solutions USA, Inc.

K-Number K193326

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HRX 2020-04-16

HydroCision SpineJet System

Applicant Hydrocision, Inc.

K-Number K200729

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DRG 2020-04-16

Philips Biosensor BX100

Applicant Philips Medical Systems

K-Number K192875

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EIH 2020-04-16

DD Contrast

Applicant Dental Direkt GmbH

K-Number K193588

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QJU 2020-04-16

Caption Guidance

Applicant Caption Health

K-Number K200755

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FIP 2020-04-16

EON Portable RO Water Purification System

Applicant Mar Cor Purification, Inc.

K-Number K200670

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LZA 2020-04-15

Black Colored Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate

Applicant Comfort Rubber Gloves Industries Sdn. Bhd.

K-Number K200181

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OWB 2020-04-15

AS-10

Applicant Canon, Inc.

K-Number K200887

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FDF 2020-04-15

G-EYE System

Applicant Smart Medical Systems , Ltd.

K-Number K192588

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FRG 2020-04-15

Diposable Medical Device Self-seal Sterilization Pouch, Disposable Medical Device Sterilization Reel Pouch

Applicant Weihai Xingtai Packaging Products Co., Ltd.

K-Number K193561

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