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

JOH 2019-03-22

Shiley Neonatal/Pediatric Tracheostomy Tube

Applicant Covidien

K-Number K182861

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DQY 2019-03-21

Ballast 088 Long Sheath

Applicant Balt USA, LLC

K-Number K182918

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DXN 2019-03-21

A&D Medical Blood Pressure Monitors

Applicant A&D Company, Ltd.

K-Number K173191

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PEW 2019-03-21

UroLift System UL400

Applicant Neotract, Inc.

K-Number K190377

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OMP 2019-03-21

RENASYS Touch; RENASYS Y-Connector

Applicant Smith & Nephew Medical Limited

K-Number K181822

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MQV 2019-03-21

Mineral Collagen Composite Bioactive Moldable

Applicant Collagen Matrix, Inc.

K-Number K182074

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NGL 2019-03-21

CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup

Applicant Hangzhou Clongene Biotech Co., Ltd.

K-Number K190412

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DQY 2019-03-21

Route 92 Medical Delivery Catheter

Applicant Route 92 Medical, Inc.

K-Number K190431

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DRE 2019-03-21

ExpanSure Transseptal Dilation System

Applicant Baylis Medical Company, Inc.

K-Number K182064

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ODP 2019-03-21

nvc

Applicant Nvision Biomedical Technologies, Inc.

K-Number K190380

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PWD 2019-03-21

ClearLLab 10C Panels (B, T, M1, M2), Navios Flow Cytometer, Navios EX Flow Cytometer

Applicant Beckman Coulter

K-Number K183592

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OWI 2019-03-21

NuVasive® VersaTie® System

Applicant Nu Vasive, Incorporated

K-Number K190418

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