Company ยท US
Ep Medsystems
FDA 510(k) clearances and medical device recalls filed under this name, 1996 to 2009. Name variants (Inc, Corp, punctuation) are merged.
15510(k) clearances (0 in 12 months)
1recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| DQK | Computer, Diagnostic, Programmable | 5 |
| JOQ | Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only) | 4 |
| DRF | Catheter, Electrode Recording, Or Probe, Electrode Recording | 3 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 2 |
| DYB | Introducer, Catheter | 1 |
| ITN | Splint, Denis Brown | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 16, 2009 | K092913 | EP-4TM CARDIAC STIMULATOR, MODELS: EP-04-02, EP-04-04 Ep Medsystems | JOQ |
| Mar 11, 2008 | K073709 | MODIFICATION TO VIEWMATE SYSTEM Ep Medsystems | IYN |
| May 1, 2007 | K071028 | VIEWMATE SYSTEM Ep Medsystems | ITN |
| Apr 11, 2007 | K070706 | EP-WORKMATE Ep Medsystems | DQK |
| Nov 30, 2006 | K063277 | MAPMATE Ep Medsystems, Inc. | DQK |
| Oct 27, 2006 | K063113 | EP-WORKMATE Ep Medsystems | DQK |
| Sep 14, 2004 | K041442 | EP-4 CLINICAL STIMUTATOR Ep Medsystems | JOQ |
| Apr 15, 2004 | K033963 | EP DEFLECTABLE CATHETERS Ep Medsystems, Inc. | DRF |
| Feb 27, 2004 | K040207 | EP-4 CLINICAL STIMULATOR Ep Medsystems | JOQ |
| Oct 17, 2003 | K031066 | VIEWMATE ULTRASOUND IMAGING SYSTEM Ep Medsystems | IYN |
| Aug 20, 2003 | K032225 | EP-WORKMATE WITH RPM SYSTEM Ep Medsystems | DQK |
| Mar 23, 2000 | K994011 | EP MEDSYSTEMS, EP-WORKMATE Ep Medsystems, Inc. | DQK |
| Jul 15, 1999 | K991001 | MODIFICATION OF PROCATH ELECTROPHYSIOLOGY CATHETER, EP MEDSYSTEMS ELECTROPHYSIOLOGY CATHETER Ep Medsystems | DRF |
| Feb 22, 1999 | K984150 | PROCATH ELECTROPHYSIOLOGY CATHETER, EP MEDSYSTEMS ELECTROPHYSIOLOGY CATHETER Ep Medsystems | DRF |
| May 13, 1996 | K961513 | PROCATH LOCKING PEEL-AWAY INTRODUCER/PEEL-AWAY INTRODUCER SET Ep Medsystems | DYB |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 31, 2006 | EP Medsystems EP-4 Computerized Stimulator -- 2 channel and 4 channel. The product consists of a touchscreen portable PC controlling a two channel dedicated EP stimulator. The stimulator is capable of single chan Terminated |
JOQ | K040207 K041442 |