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

MUD 2021-12-05

INVOS PM7100 Patient Monitor, INVOS Pediatric rSO2 Sensor, INVOS Infant Regional Saturation Sensor (also referred to as OxyAlert NIRSensor)

Applicant Covidien, LLC

K-Number K211561

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LZA 2021-12-04

Nitrile Powder Free Blue Examination Gloves, Non-Sterile

Applicant Mah Sing Healthcare Sdn. Bhd.

K-Number K212535

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LYX 2021-12-03

Independent Corneal Viewing Chamber (IVC-21)

Applicant Bausch + Lomb, Incorporated

K-Number K211786

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QNV 2021-12-03

AHI System

Applicant Fifth Eye, Inc.

K-Number K212219

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PGY 2021-12-03

21HQ513D

Applicant Lg Electronics.Inc

K-Number K212295

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CAF 2021-12-03

Sodium Chloride Inhalation Solutions, 3%, 3.5%, 7% and 10%

Applicant The Ritedose Corporation

K-Number K210126

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HAW 2021-12-03

Molecular Flow Simulations

Applicant Therataxis, LLC

K-Number K201435

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KPI 2021-12-03

Everyway Incontinence Stimulation System

Applicant Everyway Medical Instruments Co.,Ltd

K-Number K213116

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FXX 2021-12-03

Surgical Masks

Applicant Weihai Hongyu Nonwoven Fabric Products Co., Ltd.

K-Number K212807

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LLZ 2021-12-03

PVmed Contouring Software

Applicant Perception Vision Medical Technologies Ltd.Co.

K-Number K210916

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LRO 2021-12-03

Medline Cardiovascular Procedure Kit

Applicant Medline Industries, Inc.

K-Number K212258

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OWB 2021-12-03

Cydar EV (Series B) and Cydar EV Maps

Applicant Cydar , Ltd.

K-Number K212442

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