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 |
|---|---|---|---|
| Mar 3, 1987 | K864988 | ETP 180E NON-INVASIVE EXTERNAL PACEMAKER Medac, Inc. | DRO |
| Mar 3, 1987 | K864987 | DISPOS GEL EXTERNAL PACING ELECTRODE/HI IMPEDANCE Medac, Inc. | DRO |
| Mar 3, 1987 | K864986 | ETP 300 NON-INVASIVE EXTERNAL PACEMAKER Medac, Inc. | DRO |
| Oct 31, 1986 | K863547 | MEDTRONIC MODEL 5455 DISPOSABLE SURGICAL CABLE Medtronic Vascular | DRO |
| Jul 11, 1986 | K862298 | ALTERNATE SIZE E-Z-PACE ELECTRODE Medtronic Vascular | DRO |
| May 1, 1986 | K854196 | DCI MODEL EP-2 CLINICAL STIMULATOR Digital Cardiovascular Instruments, Inc. | DRO |
| Apr 30, 1986 | K860551 | ETP 180 CARDIAC PACEMAKER (EXTERNAL) Biotronics Corp. | DRO |
| Mar 31, 1986 | K860283 | AMI CARDIO-PAD Andover Medical, Inc. | DRO |
| Mar 31, 1986 | K855015 | NONINVASIVE TEMP. PACEMAKER NTP-1000 Zmi Corp. | DRO |
| Feb 26, 1986 | K854924 | AMI E-Z-PACE ELECTODE A.M.I. Corp. | DRO |
| Feb 14, 1986 | K854853 | NI-PACER 1 Associated Medical Devices, Inc. | DRO |
| Jan 13, 1986 | K854117 | AMENDMENT LIFEPAK 8, NPN 052 Physio-Control Corp. | DRO |
| Jan 8, 1986 | K854233 | CMI 3000 Cardio Management, Inc. | DRO |
| Dec 9, 1985 | K853732 | LIFEPAK 8 MODIFICATION Physio-Control Corp. | DRO |
| Nov 5, 1985 | K850812 | EMERGIPACE - EXTERNAL PACEMAKER Life Science Instrumentation, Inc. | DRO |
| Oct 11, 1985 | K852958 | PACEPAC Medical Data Electronics | DRO |
| Jun 19, 1985 | K850791 | MDI 2000 - PULSE GENERATOR Micromedical Devices, Inc. | DRO |
| Apr 19, 1985 | K851248 | AMENDMENT LIFEPAK 100, NPN 045 Physio-Control Corp. | DRO |
| Apr 19, 1985 | K851247 | AMENDMENT LIFEPAK 200, NPN 046 Physio-Control Corp. | DRO |
| Mar 6, 1985 | K850596 | PACE*AID 10 A -PAD 10A- PACEMAKER OUTPUT DISPLAY & Cardiac Resucitator Corp. | DRO |
| Feb 14, 1985 | K850170 | HEART AID MODEL 97 Cardiac Resucitator Corp. | DRO |
| Jan 24, 1985 | K844811 | PACE AID MODEL 53 Cardiac Resucitator Corp. | DRO |
| Dec 17, 1984 | K843547 | PACE *AID MODEL 52 Cardiac Resucitator Corp. | DRO |
| Nov 19, 1984 | K843358 | HEART-AID MODEL 80 Cardiac Resucitator Corp. | DRO |
| Apr 23, 1984 | K840353 | PACEMAKER PULSE GENERATOR W/ELECTRODE Ross Research, Inc. | DRO |
| Feb 4, 1984 | K840047 | LIFEPAK 7D Physio-Control Corp. | DRO |
| Feb 4, 1984 | K834262 | TRANS-PACE Micromedical Devices, Inc. | DRO |
| Jan 30, 1984 | K832876 | LIFEPAK 7P Physio-Control Corp. | DRO |
| Aug 6, 1982 | K822246 | NONINVASIVE TEMPORARY PACEMAKER Ross Research, Inc. | DRO |
| Aug 6, 1982 | K821673 | HEART*AID, ALS, MODEL 95 Cardiac Resucitator Corp. | DRO |
| Aug 6, 1982 | K821152 | HEART AID #90 Cardiac Resucitator Corp. | DRO |
| Aug 6, 1982 | K820609 | HEART *AID, #80 Cardiac Resucitator Corp. | DRO |
| Aug 6, 1982 | K820507 | PACE* AID MODEL 50 Cardiac Resucitator Corp. | DRO |
| Jan 18, 1982 | K813553 | PACE *AID Cardiac Resucitator Corp. | DRO |
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