Company ยท US
Jms North America Corp.
FDA 510(k) clearances and medical device recalls filed under this name, 2003 to 2025. Name variants (Inc, Corp, punctuation) are merged.
19510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| FIE | Needle, Fistula | 10 |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 2 |
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | 1 |
| FJK | Set, Tubing, Blood, With And Without Anti-Regurgitation Valve | 1 |
| FMF | Syringe, Piston | 1 |
| FMG | Stopcock, I.V. Set | 1 |
| FPA | Set, Administration, Intravascular | 1 |
| MPB | Catheter, Hemodialysis, Non-Implanted | 1 |
| ONB | Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 15, 2025 | K251877 | JMS CAVEO A.V. Fistula Needle Set JMS North America Corporation | FIE |
| Jun 1, 2018 | K172499 | NEOSHIELD JMS North America Corporation | ONB |
| May 13, 2015 | K151017 | JMS Harmony A.V. Fistula Needle Set JMS North America Corporation | FIE |
| Dec 23, 2014 | K142564 | JMS SysLoc MINI A.V. Fistula Needle Set (V4), JMS SysLoc MINI Apheresis Needle Set (V4) JMS North America Corporation | FIE |
| Feb 20, 2014 | K132321 | JMS SYRINGE JMS North America Corporation | FMF |
| Mar 5, 2013 | K121488 | JMS SAFE WING CATH (SWC) JMS North America Corporation | FOZ |
| Oct 27, 2011 | K112178 | JMS APHERESIS NEEDLE SET WINGEATER(R) V2 JMS North America Corporation | FIE |
| Oct 24, 2011 | K111948 | WINGEATER V2 JMS North America Corporation | FIE |
| Feb 11, 2011 | K110157 | SYSLOC MINI V3 JMS North America Corporation | FIE |
| Feb 9, 2010 | K093637 | JMS BLUNT A. V. FISTULA NEEDLE SET WITH SITE PREPARATION TOOL MODEL 820-5300, 820-6300 AND 820-7300 Jms North America Corp. | FIE |
| Jan 21, 2009 | K082882 | A.V. FISTULA BLUNT NEEDLE SET Jms North America Corp. | FIE |
| May 22, 2007 | K070234 | JMS SYSLOC MINI AVF AND APHERESIS NEEDLE SETS Jms North America Corp. | MPB |
| Apr 10, 2007 | K070143 | JMS PLANECTA STOPCOCK Jms North America Corp. | FMG |
| Aug 4, 2005 | K051814 | JMS SYSLOC MINI A.V. FISTULA NEEDLE SET AND APHERESIS NEEDLE SET Jms North America Corp. | FIE |
| Aug 16, 2004 | K032975 | JMS BLOOD TUBING SETS Jms North America Corp. | FJK |
| May 25, 2004 | K032977 | JMS BYPASS TUBE Jms North America Corp. | DWF |
| Mar 3, 2004 | K040247 | PLUME SAFETY AVF NEEDLE Jms North America Corp. | FIE |
| Aug 18, 2003 | K030479 | JMS SYSLOC A.V. FISTULA NEEDLE SET, JMS SYSLOC APHERESIS NEEDLE SET Jms North America Corp. | FOZ |
| Jul 1, 2003 | K023668 | JMS EXTENSION SET WITH PLANECTA, PLANECTA (STAND ALONE UNIT), PLANECTA LOCK & PLANECTA ADAPTOR Jms North America Corp. | FPA |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||