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

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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PNO 2020-04-15

Serranator PTA Serration Balloon Catheter

Applicant Cagent Vascular, LLC

K-Number K193181

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MUH 2020-04-15

I-View Gold and Imagen Gold Dental Sensors

Applicant Trident S.R.L

K-Number K200625

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PHX 2020-04-15

Comprehensive® Reverse Shoulder

Applicant Biomet, Inc.

K-Number K193373

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FRA 2020-04-15

Molekule Air Pro RX

Applicant Molekule, Inc.

K-Number K200500

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FRC 2020-04-15

3MTM AttestTM Mini Auto-reader 490M

Applicant 3M

K-Number K200092

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EOQ 2020-04-15

Monarch Platform

Applicant Auris Health, Inc.

K-Number K193534

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IYN 2020-04-15

ACUSON Sequoia Diagnostic Ultrasound System

Applicant Siemens Medical Solutions USA, Inc.

K-Number K200707

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