Company ยท US
NuMED, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1985 to 2022. Name variants (Inc, Corp, punctuation) are merged.
49510(k) clearances (0 in 12 months)
5recalls (0 in 12 months)
4recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| DQY | Catheter, Percutaneous | 12 |
| LIT | Catheter, Angioplasty, Peripheral, Transluminal | 8 |
| DQO | Catheter, Intravascular, Diagnostic | 7 |
| NVM | Catheter, Angioplasty, Peripheral, Transluminal, Dual-Balloon | 6 |
| MJN | Catheter, Intravascular Occluding, Temporary | 5 |
| DXF | Catheter, Septostomy | 3 |
| LDF | Electrode, Pacemaker, Temporary | 3 |
| DYB | Introducer, Catheter | 2 |
| OMZ | Pulmonary (Pulmonic) Valvuloplasty Catheters/Percutaneous Valvuloplasty Catheter | 2 |
| OZT | Balloon Aortic Valvuloplasty | 2 |
| DPT | Probe, Blood-Flow, Extravascular | 1 |
| DYG | Catheter, Flow Directed | 1 |
| KRB | Probe, Thermodilution | 1 |
| MAF | Stent, Coronary | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 12, 2022 | K213915 | BIB Stent Placement Catheter NuMED, Inc. | NVM |
| Jul 19, 2021 | K211910 | Z-6 Atrioseptostomy Catheter NuMED, Inc. | DXF |
| May 27, 2021 | K211134 | BIB Stent Placement Catheter NuMED, Inc. | NVM |
| May 14, 2019 | K190974 | D'Vill Introducer NuMED, Inc. | DYB |
| Oct 20, 2017 | K171206 | D'Vill Introducer NuMED, Inc. | DYB |
| Sep 22, 2016 | K161451 | BIB Stent Placement Catheter NuMED, Inc. | NVM |
| Jun 20, 2016 | K160598 | REBOA Balloon Catheter NuMED, Inc. | MJN |
| May 20, 2016 | K160889 | BIB Stent Placement Catheter NuMED, Inc. | NVM |
| Aug 8, 2013 | K131869 | PTS-X SIZING BALLOON CATHETER NuMED, Inc. | MJN |
| Oct 4, 2012 | K122012 | Z-MED Z-MED II NuMED, Inc. | OZT |
| Aug 31, 2012 | K121859 | TYSHAK NUCLEUS NuMED, Inc. | DQY |
| Jun 11, 2012 | DEN080015 | NUCLEUS-X PTV CATHETER NuMED, Inc. | OZT |
| Apr 29, 2011 | K110903 | PTS-X SIZING BALLOON CATHETER NuMED, Inc. | MJN |
| Dec 9, 2010 | K102473 | MULLINS-X PTV CATHETER NuMED, Inc. | OMZ |
| Oct 24, 2008 | K082868 | MULLINS-X, MODEL 250X NuMED, Inc. | DQY |
| Sep 26, 2008 | K082524 | MINI GHOST, MODEL: 507 NuMED, Inc. | DQY |
| Jul 10, 2008 | K081680 | NUCLEUS-X, MODEL 230X NuMED, Inc. | DQY |
| Jul 28, 2005 | K051343 | MINI GHOST PTA CATHETER, MODEL 507 NuMED, Inc. | DQY |
| Jul 28, 2005 | K050857 | BIB PTA BALLOON CATHETER NuMED, Inc. | NVM |
| Jun 18, 2004 | K040830 | PTA, PTV, ATRIOSEPTOSTOMY, ANGIOGRAPHIC, SIZING CATHETERS NuMED, Inc. | DQO |
| Jun 10, 2004 | K041306 | NUMED PTS X SIZING BALLOON CATHETER NuMED, Inc. | MJN |
| May 6, 2004 | K041093 | NUMED MULLINS X PTA CATHETER NuMED, Inc. | DQY |
| Sep 25, 2003 | K032591 | NUMED TYSHAK MINI PEDIATRIC PTV CATHETER NuMED, Inc. | DQY |
| May 21, 2003 | K030589 | MODIFICATION TO NUMED TYSHAK II AND Z-MED II PTV CATHETERS NuMED, Inc. | DQY |
| Sep 13, 2002 | K022722 | PTA AND PTV NuMED, Inc. | DQY |
| Jan 16, 2002 | K014124 | NUMED COEFFICIENT PTV CATHETERS NuMED, Inc. | OMZ |
| Jan 3, 2002 | K013601 | NUMED MULLINS PTA CATHETER NuMED, Inc. | DQY |
| Jul 12, 2001 | K011557 | PTA, PTV, ATRIOSEPTOSTOMY, ANGIOGRAPHIC, SIZING CATHETERS NuMED, Inc. | DXF |
| May 2, 2001 | K003320 | PTA-OS SIZING BALLOON, MODEL 360 NuMED, Inc. | MJN |
| Apr 20, 2001 | K010880 | NUMED HIGH PRESSURE PTA CATHETERS NuMED, Inc. | DQY |
| Jan 11, 2001 | K003972 | NUMED GHOST II PTA CATHETERS NuMED, Inc. | LIT |
| Jan 11, 2001 | K003902 | MULTITRACK ANGIOGRAPHIC CATHETER NuMED, Inc. | DQO |
| Dec 27, 2000 | K003643 | NUMED Z-MED PTV CATHERERS NuMED, Inc. | DQY |
| Dec 1, 2000 | K003276 | TYSHAK MINI PEDIATRIC PTV CATHETER, MODEL 107 NuMED, Inc. | LIT |
| Nov 1, 2000 | K003114 | NUMED TYSHAK AND Z-MED PTV CATHETERS NuMED, Inc. | LIT |
| Nov 1, 2000 | K003052 | NUMED TYSHAK II AND Z-MED II PTV CATHETERS NuMED, Inc. | LIT |
| Sep 27, 2000 | K991977 | TYSHAK, MODEL 102 AND Z-MED, MODEL 302 NuMED, Inc. | LIT |
| Jul 12, 2000 | K001804 | NUMED Z-5 ATRIOSEPTOSTOMY CATHETER NuMED, Inc. | DXF |
| Apr 2, 1996 | K960070 | NUMED ATRIOSEPTOSTOMY CATHETER NuMED, Inc. | DQO |
| Dec 21, 1993 | K931009 | TYSHAK PERIPHERAL BALLOON DILATION CATHETER NuMED, Inc. | LIT |
| Apr 21, 1989 | K883948 | MODIFIED NUMED BALLOON ANGIOGRAPHIC CATHETER NuMED, Inc. | DYG |
| Sep 6, 1988 | K881893 | NUMED BALLOON THERMODILUTION CATHETER NuMED, Inc. | KRB |
| Dec 3, 1987 | K871796 | NUMED PTA CATHETERS NuMED, Inc. | LIT |
| Feb 20, 1987 | K864943 | NUMED BALLOON WEDGE PRESSURE CATHETER NuMED, Inc. | DQO |
| Feb 19, 1987 | K864940 | NUMED BALLOON ANGIOGRAPHIC CATHETERS NuMED, Inc. | DQO |
| Jun 2, 1986 | K860121 | INTRAVASCULAR CATHETER W/DOPPLER TRANSDUCER NuMED, Inc. | DPT |
| Aug 29, 1985 | K851845 | NUMED TEMP. STYLET PACING PAROBE 1318694 NuMED, Inc. | LDF |
| Apr 19, 1985 | K851246 | NUMED BALLOON PACING CATHETER NuMED, Inc. | LDF |
| Jan 14, 1985 | K843290 | NUMED BALLOON PACING CATHETER NuMED, Inc. | LDF |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 13, 2025 | Numed Inc BIB Balloon in Balloon Dilatation Catheter. Model Number: 420 Terminated |
NVM | K050857 |
| Oct 17, 2018 | Numed Inc Multi-Track Angiographic Catheter (MMTA)
Product Code: MMTA06100
Product Usage:
Recommended for use in catheterization for angiography of cardiovascular vessels and I or chambers. It can be used for i Terminated |
DQO | K952984 |
| Oct 17, 2018 | Numed Inc Multi-Track Angiographic Catheter (MMTA)
Product Code: MMTA05100
Product Usage:
Recommended for use in catheterization for angiography of cardiovascular vessels and I or chambers. It can be used for i Terminated |
DQO | K952984 |
| Dec 15, 2009 | Numed Inc IMPACT Catheters, Balloon Dilatation and Esophageal Dilatation Catheter, Model Number 307, STERILE, Rx only
--- Common/Usual Name: PTA and Esophageal Catheter
--- Manufactured for: B. Braun Interv Terminated |
LIT | K931009 K983373 |
| Jul 8, 2003 | Numed Inc CP STENT (Cheatham Platinum), a prescription device, composed of 90% platinum/10% iridium wire arranged in laser welded rows with a ''zig'' pattern. The number of zigs can be varied and will impact t Terminated |
MAF | None listed |