Navilyst Medical, Inc.

• LJS — General Hospital16 devices
• FGE — Gastroenterology, Urology4 devices
• LJT — General Hospital4 devices
• DQO — Cardiovascular3 devices
• DRE — Cardiovascular2 devices
• FOZ — General Hospital2 devices
• DTL — Cardiovascular1 device
• DXT — Cardiovascular1 device
• FMF — General Hospital1 device
• MSD — Gastroenterology, Urology1 device

• Z-1189-2015 — NAMIC Convenience Kit, UPN H749602301481, REF/Catalog No. 60230148, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588. NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems.Class II·Terminated·2015-01-09
• Z-1194-2015 — NAMIC Convenience Kit, ANGIO DOUBLE SPIKE KIT, UPN H9656003028111, REF/Catalog No. 600302811, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136683. NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems.Class II·Terminated·2015-01-09
• Z-1204-2015 — NAMIC Convenience Kit, UPN H965607011741, REF/Catalog No. 60701174, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588. NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems.Class II·Terminated·2015-01-09
• Z-1162-2015 — NAMIC Convenience Kit, LEFT HEART KIT, UPN H749600618011, REF/Catalog No. 60061801, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588. Product Usage: NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems.Class II·Terminated·2015-01-09
• Z-1170-2015 — NAMIC Convenience Kit, UPN H749601314811, REF/Catalog No. 60131481, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588. Product Usage: NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems.Class II·Terminated·2015-01-09
• Z-1199-2015 — NAMIC Convenience Kit, UPN H965601206511, REF/Catalog No. 60120651, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588. NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems.Class II·Terminated·2015-01-09
• Z-1164-2015 — NAMIC Convenience Kit, 3 VALVE KIT, UPN H749600709971, REF/Catalog No. 60070997, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588. Product Usage: NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems.Class II·Terminated·2015-01-09
• Z-1195-2015 — NAMIC Convenience Kit, UPN H965600338021, REF/Catalog No. 60033802, STERILE, Rx ONLY ---For single use only. --- Device Listing Number D136588. NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems.Class II·Terminated·2015-01-09
• Z-1152-2015 — NAMIC Convenience Kit, LEFT HEART KIT, UPN H749600309351, REF/Catalog No. 60030935, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588. Product Usage: NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems.Class II·Terminated·2015-01-09
• Z-1171-2015 — NAMIC Convenience Kit, UPN H7496013148131, REF/Catalog No. 601314813, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588. Product Usage: NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems.Class II·Terminated·2015-01-09

Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.

• K163452 — PICC Maximal Barrier Nursing KitCode LJS·2017-02-03
• K161866 — BioFlo Midline CatheterCode FOZ·2016-09-08
• K151239 — NMI DUAL PORT IICode LJT·2016-06-06
• K153228 — NMI Port, NMI Port IICode LJT·2015-12-04
• K152069 — Exodus Array Multipurpose Drainage Catheter, Exodus Nuance Nephrostomy Drainage Catheter, Exodus Believe Biliary Drainage CatheterCode FGE·2015-09-24
• K152409 — Xcela PICC with PASV, Xcela Hybrid PICC with PASV, Xcela Power Injectable PICCCode LJS·2015-09-24
• K150407 — BioFlo Midline CatheterCode FOZ·2015-05-15
• K150527 — Xcela Power Injectable PICCCode LJS·2015-03-31
• K150448 — NMI PICC III and NMI PICC IVCode LJS·2015-03-19
• K142616 — PICC Maximal Barrier Nursing KitCode LJS·2014-10-14
• K140194 — NAMIC RCS SYRINGECode FMF·2014-04-14
• K140266 — NMI PICC IVCode LJS·2014-03-05
• K131260 — NMI DIALYSIS CATHETERCode MSD·2014-02-14
• K133264 — NMI PICC IIICode LJS·2013-11-20
• K132713 — NMI COAXIAL MICROINTRODUCER SETCode DRE·2013-09-27
• K131694 — NMI PORT II CATHETERCode LJT·2013-08-08
• K131942 — NMI PICC III CATHETER, NMI HPICC III CATHETERCode LJS·2013-07-31
• K131038 — NMI PICC MAXIMAL BARRIER NURSING KITSCode LJS·2013-05-09
• K122767 — NMI PORTCode LJT·2013-04-30
• K123445 — NMI COAXIAL MICROINTRODUCER SETCode DRE·2013-04-01
• K122882 — NMI HPICC IIICode LJS·2012-10-18
• K121089 — NMI PICC IIICode LJS·2012-08-23
• K121990 — PICC CONVENIENCE KITCode LJS·2012-08-03
• K121954 — NMI MICROCATHETERCode DQO·2012-07-17
• K113638 — NMI 2.8 MICROCATHETERCode DQO·2012-01-05
• K113198 — NMI CONTROL SYRINGE, 7 ML NMI CONTROL SYRINGE, 8 MLCode DXT·2011-11-28
• K112124 — MICROCATHETERCode DQO·2011-08-19
• K111906 — XCELA HYBRID PICC WITH PASV VALVE TECHNOLOGYCode LJS·2011-07-29
• K111315 — MULTIPURPOSE DRAINAGE CATHETERCode FGE·2011-06-08
• K103353 — MULTIPURPOSE DRAINAGE CATHETER; NEPHROSTOMY DRAINAGE CATHETER; BILIARY DRAINAGE CATHETERCode FGE·2011-01-14
• K101326 — NMI ICCode LJS·2010-09-02
• K091634 — NMI FCCode DTL·2010-03-01
• K093392 — MULTIPURPOSE, NEPHROSTOMY AND BILIARY DRAINAGE CATHETERSCode FGE·2009-12-31
• K093366 — NMI PICC IICode LJS·2009-11-24
• K091261 — NMI PICCCode LJS·2009-05-12