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

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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IYN 2020-04-08

Z6/Z60/Z60T/Z60S/Z60 Pro/DP-60 Diagnostic Ultrasound System

Applicant Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

K-Number K200411

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KCT 2020-04-08

TCAT TKA Instrument Tray Set

Applicant THINK Surgical, Inc.

K-Number K200632

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DQX 2020-04-08

Go2Wire Guide Wire

Applicant Merit Medical System, Inc.

K-Number K193571

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KNT 2020-04-08

Standard Bougie

Applicant Standard Bariatrics

K-Number K191885

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MOS 2020-04-08

Flex Body Speeder

Applicant Quality Electrodynamics, LLC

K-Number K200477

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GEI 2020-04-08

Voyant Maryland Fusion Device

Applicant Applied Medical Resources Corp.

K-Number K200598

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FTL 2020-04-08

TYRX Neuro Absorbable Antibacterial Envelope (Medium), TYRX Neuro Absorbable Antibacterial Envelope (Large)

Applicant Medtronic, Inc.

K-Number K192636

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