Medical Device Manufacturer · US , Marlborough , MA

Navilyst Medical, Inc. - FDA 510(k) Cleared Devices

35 submissions · 33 cleared · Since 2009

Official Website

35

Total

33

Cleared

0

Denied

FDA 510(k) Regulatory Record - Navilyst Medical, Inc. General Hospital ✕

23 devices

1-12 of 23

Cleared Feb 03, 2017

PICC Maximal Barrier Nursing Kit

General Hospital · 56d

Cleared Sep 08, 2016

BioFlo Midline Catheter

General Hospital · 63d

Cleared Jun 06, 2016

NMI DUAL PORT II

General Hospital · 392d

Cleared Dec 04, 2015

NMI Port, NMI Port II

General Hospital · 28d

Cleared Sep 24, 2015

Xcela PICC with PASV, Xcela Hybrid PICC with PASV, Xcela Power Injectable PICC

General Hospital · 29d

Cleared May 15, 2015

BioFlo Midline Catheter

General Hospital · 86d

Cleared Mar 31, 2015

Xcela Power Injectable PICC

General Hospital · 29d

Cleared Mar 19, 2015

NMI PICC III and NMI PICC IV

General Hospital · 27d

Cleared Oct 14, 2014

PICC Maximal Barrier Nursing Kit

General Hospital · 28d

Cleared Apr 14, 2014

NAMIC RCS SYRINGE

General Hospital · 77d

Cleared Mar 05, 2014

General Hospital · 30d

Cleared Nov 20, 2013

General Hospital · 28d