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

LZA 2020-04-09

Powder Free Nitrile Examination Glove (Aqua Green)

Applicant Riverstone Resources Sdn Bhd

K-Number K200326

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MUJ 2020-04-09

ClearCalc

Applicant Radformation, Inc.

K-Number K193640

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GWM 2020-04-09

Medtronic External Drainage and Monitoring System, Medtronic External Drainage and Monitoring System, Becker Replacement Drainage Bags

Applicant Medtronic, Inc.

K-Number K200630

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LLZ 2020-04-09

EchoNavigator

Applicant Philips Medical Systems Nederland B.V.

K-Number K200713

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DQA 2020-04-09

OxSAT 100

Applicant S.L.P. , Ltd.

K-Number K191574

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GCJ 2020-04-09

Standard Trocar

Applicant Standard Bariatrics

K-Number K200517

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CHL 2020-04-09

i-STAT CG4+ Cartridge with the i-STAT 1 System

Applicant Abbott Point of Care, Inc.

K-Number K200492

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HRS 2020-04-09

ATLAS Plating System

Applicant MiRus, LLC

K-Number K191867

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LZA 2020-04-09

Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with Chemotherapy Drugs and Fentanyl

Applicant Sri Trang Gloves (Thailand) Public Company Limited

K-Number K200539

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QAI 2020-04-09

Rejuvapen NXT

Applicant Refine USA, LLC

K-Number K192138

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DSI 2020-04-09

Unified Arrhythmia Diagnostic System PocketECG IV

Applicant Medicalgorithmics S.A.

K-Number K193104

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BYS 2020-04-09

Nautilus Smart ECMO Module

Applicant Mc3 Incorporated

K-Number K191935

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