Panels › Cardiovascular › Product code DRO · Class 2
Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)
Regulation 870.5550
0510(k)s in 12 months (84 all time)
0recalls in 12 months (22 all time)
10recalls that name a 510(k)
Top companies in DRO
| Company | 510(k)s | Recalls |
|---|---|---|
| Cardiac Resucitator Corp. | 13 | 0 |
| Smiths Medical ASD Inc. | 0 | 12 |
| Physio-Control Corp. | 10 | 0 |
| Cardiotronics, Inc. | 9 | 0 |
| Covidien LLC | 0 | 8 |
| Medac, Inc. | 8 | 0 |
| Katecho, Inc. | 4 | 0 |
| Zmi Corp. | 4 | 0 |
| Medical Data Electronics | 3 | 0 |
| Tz Medical, Inc. | 2 | 1 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 12, 2001 | K012404 | K-DEFIB/PACE ADULT ELECTRODE, MODEL KDP-85 Katecho, Inc. | DRO |
| Oct 12, 2001 | K012218 | LUDLOW GRADIENT EDGE ADULT & PEDIATRIC MULTIFUNCTIONAL ELECTRODES The Ludlow Company LP | DRO |
| Mar 28, 2000 | K000660 | ESCORT II+ 400 SERIES (ESCORT PRISM), MODEL 20400, 20401, 20403, MONITOR, MODELS 20411, 20412, 20413 Medical Data Electronics | DRO |
| Sep 15, 1999 | K983232 | PADTAK PEDIATRIC DEFIB/CARDIOVERT/PACE/MONITOR-RADIOTRANSPARENT (2X2.25),MODEL 2602, PADTAK PEDIATRIC DEFIB/CARDIOVERT Tz Medical, Inc. | DRO |
| Sep 15, 1999 | K983196 | PADTAK PACE/DEFIB/CARDIOVERT MONITORING ELECTRODE(S) Tz Medical, Inc. | DRO |
| Mar 2, 1998 | K974034 | PORTABLE INTENSIVE CARE UNIT Medical Research Laboratories, Inc. | DRO |
| Mar 6, 1997 | K962547 | CARDIOSERV P Marquette Electronics, Inc. | DRO |
| Feb 28, 1997 | K963120 | RESPONDER 2500 DEFIBRILLATOR AND CARDIAC CARE SYSTEM Marquette Electronics, Inc. | DRO |
| Dec 10, 1996 | K961138 | ESORT II + 400 SERIES MONITOR Medical Data Electronics | DRO |
| Dec 29, 1995 | K951593 | LIFEPAK 11 Physio-Control Corp. | DRO |
| Dec 29, 1995 | K950856 | ZOLL PD2000 PACEMAKER/ADVISORY DEFIBRILLATOR, MODEL PD2000, ZOLL D2000 ADVISORY DEFIBRILLATOR, MODEL D2000 Zoll Medical Corp | DRO |
| May 22, 1995 | K950483 | HEWLETT PACKARD M2475B CODEMASTER 100 DEFIBRILLATOR/MONITOR Hewlett-Packard Co. | DRO |
| Apr 15, 1993 | K926175 | K-DEFIB/PACE CARBON ELECTRODE Katecho, Inc. | DRO |
| Jul 30, 1992 | K915757 | MODELS M1722A, M1723A, M1724A DEFIBRILLATORS Hewlett-Packard Co. | DRO |
| Jun 29, 1992 | K915328 | GEL-TAC Katecho, Inc. | DRO |
| May 14, 1992 | K914955 | K-DEFIB/PACE ELECTRODE Katecho, Inc. | DRO |
| Sep 11, 1991 | K912599 | QUIK-PACE(R) OR EX-PACE(TM) PEDIATRIC PACING ELEC Physio-Control Corp. | DRO |
| Jul 31, 1991 | K911956 | ZOLL PD-1400 PACER/DEFIBRILLATOR Zmi Corp. | DRO |
| May 2, 1991 | K910661 | MODEL 205 SHOCK-TRODE Cardiotronics, Inc. | DRO |
| Nov 16, 1990 | K903437 | DISPOS ACCESS EXTERNAL CARDIAC PACEMAKER Keller Medical Specialties Products, Inc. | DRO |
| Dec 20, 1989 | K894492 | NKA MODEL SEC-3102 CARDIAC STIMULATOR Nihon Kohden America, Inc. | DRO |
| Oct 26, 1989 | K894588 | DEFIB/PACING PADS Conmedcorp | DRO |
| Oct 12, 1989 | K895729 | R2 PACE PAD, MODEL 480 Darox Corp. | DRO |
| Oct 12, 1989 | K895728 | R2 PACE ADAPTOR CABLE, MODEL 196 Darox Corp. | DRO |
| May 1, 1989 | K885166 | ZMI PART NO. NTP-2100, PEDIATRIC ELECTRODES Zmi Corp. | DRO |
| Jan 12, 1989 | K885171 | MODIFIED LABEL CHANGE TO MODEL 5455 SURGICAL CABLE Andover Medical, Inc. | DRO |
| Dec 16, 1988 | K880932 | MRL PACETTE, 450SLL Medical Research Laboratories, Inc. | DRO |
| Nov 18, 1988 | K884532 | TRIAD-EP II, PUSHBUTTON, CABLE INPUT Cardiotronics, Inc. | DRO |
| Nov 17, 1988 | K884530 | TRIAD-EP II, PLATE INPUT Cardiotronics, Inc. | DRO |
| Nov 9, 1988 | K883304 | TRAID-EP, PLATE INPUT, W/PULSE BLANKING CIRCUITRY Cardiotronics, Inc. | DRO |
| Nov 9, 1988 | K883178 | TRIAD-EP, PUSHBUTTON, CABLE INPUT TYPE Cardiotronics, Inc. | DRO |
| Oct 6, 1988 | K883523 | TRIAD-EP, PUSHBUTTON, CABLE INPUT TYPE, W/PULSE Cardiotronics, Inc. | DRO |
| Sep 20, 1988 | K883121 | QUIK-PACE II ELECTRODES Physio-Control Corp. | DRO |
| Aug 30, 1988 | K883375 | MODEL #918 MULTI-PADS Cardiotronics, Inc. | DRO |
| Aug 30, 1988 | K882338 | MODEL #716 ADULT STIM. PADS LOW IMPEDANCE GEL TYPE Cardiotronics, Inc. | DRO |
| Aug 19, 1988 | K882168 | EXTERNAL PACEMAKER 2000 (EP2000) Unomed, Inc. | DRO |
| Jul 18, 1988 | K880936 | TRIAD-EP Cardiotronics, Inc. | DRO |
| Jan 27, 1988 | K874447 | DISPOSABLE GEL DEFIBRILLATION/EXTERNAL PACING ELEC Medac, Inc. | DRO |
| Dec 29, 1987 | K871751 | QUIK-PACE NONINVASIVE PACEMAKER Physio-Control Corp. | DRO |
| Dec 15, 1987 | K874090 | 300M ECG MONITRO/TRANSCUTANEOUS PACEMAKER Medac, Inc. | DRO |
| Nov 23, 1987 | K873402 | ZOLL NTP-1200 PACER/DEFIBRILLATOR Zmi Corp. | DRO |
| Nov 4, 1987 | K872778 | PACESTART Pacific Rim Engineering & Mfg. | DRO |
| Sep 18, 1987 | K872368 | MODIFIED VERSA STIM ELECTRODE LINE Conmedcorp | DRO |
| Jun 29, 1987 | K872012 | LECTEC NON-INVASIVE PACING ELECTRODE Lectec Corp. | DRO |
| Jun 24, 1987 | K871971 | MODIFIED PACE*AID MODEL 53 Cardiac Resucitator Corp. | DRO |
| Jun 24, 1987 | K871538 | STAT-PAD (TM) Cardiac Resucitator Corp. | DRO |
| Jun 8, 1987 | K871569 | MODIFIED HEART*AID 97 AUTO. EXTERNAL DEFIBRILLATOR Cardiac Resucitator Corp. | DRO |
| Apr 23, 1987 | K871176 | PACE 10 NON-INVASIVE EXTERNAL PACEMAKER Medac, Inc. | DRO |
| Mar 10, 1987 | K864985 | DISPOS GEL EXTERNAL PACING ELECTRODE/LOW IMPEDANCE Medac, Inc. | DRO |
| Mar 3, 1987 | K864989 | ETP 180A NON-INVASIVE EXTERNAL PACEMAKER Medac, Inc. | DRO |
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