Company ยท US
Ela Medical, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1979 to 2004. Name variants (Inc, Corp, punctuation) are merged.
43510(k) clearances (0 in 12 months)
11recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| DXY | Implantable Pacemaker Pulse-Generator | 24 |
| DTB | Permanent Pacemaker Electrode | 11 |
| MRM | Defibrillator, Implantable, Dual-Chamber | 4 |
| DQK | Computer, Diagnostic, Programmable | 3 |
| LWS | Implantable Cardioverter Defibrillator (Non-Crt) | 3 |
| DTC | Analyzer, Pacemaker Generator Function | 2 |
| DSI | Detector And Alarm, Arrhythmia | 1 |
| ELA | Instrument, Hand, Calculus Removal | 1 |
| MWJ | Electrocardiograph, Ambulatory (Without Analysis) | 1 |
| NIK | Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) | 1 |
| NVZ | Pulse Generator, Permanent, Implantable | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 20, 2004 | K042002 | SYNESCOPE, EASYSCOPE, SYNECOM, HOLTERREADER Ela Medical, Inc. | DQK |
| Aug 22, 2003 | K032466 | SPIDERVIEW Ela Medical, Inc. | MWJ |
| May 2, 2001 | K002817 | SYNETEC Ela Medical, Inc. | DQK |
| Apr 10, 2000 | K993448 | STELA UT46 AND BT45/46 STRAIGHT TINED PACING LEADS, STELA UJ45 AND BJ44/45 J-SHAPED TINED PACING LEADS Ela Medical, Inc. | DTB |
| Apr 4, 2000 | K000029 | STELA UT46 AND BT45/46 STRAIGHT TINED PACING LEADS, STELA UJ45 AND BJ44/45 J-SHAPED TINED PACING LEADS Ela Medical, Inc. | DTB |
| Nov 26, 1999 | K990727 | SYNEFLASH & SYNEVIEW Ela Medical, Inc. | DQK |
| Jan 8, 1998 | K972574 | STELA MODEL UJ45 PACING LEADS Ela Medical, Inc. | DTB |
| Aug 29, 1997 | K970072 | OPUS S MODEL 4121 AND 4124 PACEMAKERS Ela Medical, Inc. | DXY |
| May 23, 1997 | K963738 | STELA MODEL BJ44 AND BJ45 PACING LEADS Ela Medical, Inc. | DTB |
| Sep 1, 1995 | K952364 | OPUS PACEMAKERS (MODELS 4001, 4003, 4004, 4023, 4024) Ela Medical, Inc. | DXY |
| Aug 15, 1995 | K952363 | OPUS PACEMAKERS (MODELS 4021, 4033, AND 4034) Ela Medical, Inc. | ELA |
| Jul 17, 1990 | K896742 | FOCUS J81F, J83F, J41F, J43F PACING LEADS Ela Medical, Inc. | DTB |
| Apr 4, 1990 | K895806 | ELATEC HOLTER ANALYZER Ela Medical, Inc. | DSI |
| Mar 14, 1990 | K900461 | OPUS MODEL 4021, VVI, 5MM UNIPOLAR Ela Medical, Inc. | DXY |
| Sep 26, 1989 | K894065 | OPUS MODEL 4001 Ela Medical, Inc. | DXY |
| Sep 20, 1989 | K894267 | OPUS MODELS 4033 AND 4034 Ela Medical, Inc. | DXY |
| Jun 20, 1989 | K890018 | PACEMAKER LEAD ADAPTER Ela Medical, Inc. | DTB |
| Jan 25, 1989 | K883037 | UNILITH 3 MODELS 7580/7583/7680/7683 Ela Medical, Inc. | DXY |
| Dec 8, 1988 | K884394 | PACING LEADS FOCUS T81,T81F,T82F,T83,T83F,T84F Ela Medical, Inc. | DTB |
| Nov 14, 1988 | K882391 | OPUS 3 PULSE GENERATORS MODELS 4003,4004,4023,4024 Ela Medical, Inc. | DXY |
| Sep 23, 1988 | K882427 | CARDIAC PACE. OPUS 4000 MODELS 4043/4044/4063/4066 Ela Medical, Inc. | DXY |
| Sep 12, 1988 | K882476 | OPUS PULSE GENERATORS MODELS 3001, 3003 AND 3004 Ela Medical, Inc. | DXY |
| Sep 12, 1988 | K882474 | OPUS PULSE GENERATORS MODELS 2001, 2003 AND 2004 Ela Medical, Inc. | DXY |
| Sep 15, 1987 | K872731 | PICF 0860/PSCF 0860/PSC 0860/PIAF 0860/PSAF 0860 Ela Medical, Inc. | DTB |
| Feb 10, 1987 | K863898 | MULTILITH 3 MODELS 1350, 3350, 1370, 3370 Ela Medical, Inc. | DXY |
| Mar 31, 1986 | K852973 | UNILITH 2 PULSE GENERATORS #7550, 7552, 7760, 7762 Ela Medical, Inc. | DXY |
| Aug 29, 1985 | K851731 | ELA MEDICAL PACING LEADS PMC 860 PMCF 860 PBCF860 Ela Medical, Inc. | DTB |
| Jul 25, 1985 | K853017 | ELA MEDICAL CARDIAC PACEMAKERS MULTIL 2 #1251&2251 Ela Medical, Inc. | DXY |
| Jan 10, 1985 | K842193 | MULTILITH PULSE GENERATORS, 1141 & 2141 Ela Medical, Inc. | DXY |
| Nov 29, 1984 | K842220 | MULTILITH 2 PULSE GENERATOR 1141 & 2141 Ela Medical, Inc. | DXY |
| Mar 17, 1983 | K830457 | PACING LEAD #PMA F 860 Ela Medical, Inc. | DTB |
| Mar 17, 1983 | K830401 | UNILITH PULSE GENERATOR VVI #7542 Ela Medical, Inc. | DXY |
| Feb 12, 1982 | K813246 | MEDICAL MULTILITH PULSE GENERA-1140 Ela Medical, Inc. | DXY |
| Jul 20, 1981 | K810887 | ELA MEDICAL UNILITH 7540 PULSE GENERATOR Ela Medical, Inc. | DXY |
| May 29, 1981 | K810489 | MULTILITH PULSE GENERATOR #1140 Ela Medical, Inc. | DXY |
| May 29, 1981 | K810142 | ELA MEDICAL UNILITH PULSE GENERATOR Ela Medical, Inc. | DXY |
| Mar 9, 1981 | K810626 | ELA MEDICAL PACING LEAD MODEL PMA 860 Ela Medical, Inc. | |
| Mar 25, 1980 | K792602 | SUSI II PACEMAKER SURVEILLANCE MONITOR Ela Medical, Inc. | DTC |
| Jan 31, 1980 | K791975 | PACING SYSTEM ANALYZER PSA SCE-22 Ela Medical, Inc. | DTC |
| Nov 7, 1979 | K792239 | ELA MEDICAL ANATEC HOLTER SCANNER Ela Medical, Inc. | |
| Jul 30, 1979 | K791219 | UNILITH PULSE GENERATOR Ela Medical, Inc. | DXY |
| May 8, 1979 | K790562 | PULSE GENERATOR MODEL 61 AND 128 Ela Medical, Inc. | DXY |
| Apr 3, 1979 | K790386 | LEAD MODELS MUM 1260, MUM 1290 Ela Medical, Inc. | DTB |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 22, 2011 | ela Medical Llc Paradym DR Model 8550 and Paradym VR Model 8250, Sterile EO, Manufactured in Italy by Sorin CRM S. r.l., Via Crescentino s.n., 13040 Saluggia(VC) Italy
PARADYM DR 8550 and PARADYM VR 8250 are indicat Terminated |
MRM | None listed |
| Sep 27, 2010 | ela Medical Llc Sorin Paradym CRT-D Model 8750 and Sorin Group Paradym sonR CRT-D Model 8770.
Made in Italy by Sorin Biomedical CRM S.r.l. Via Crescentino s.n. , 13040 Saluggia (VC) Italy Terminated |
NIK | None listed |
| Sep 24, 2009 | ela Medical Llc Sorin Group Reply DR Rate responsive dual-chamber pacemaker. Made in Italy by: Sorin BioMedica CRM S.r.l., Via Crescentino s.n., 13040 Saluggia (VC) Italy. ELA Medical, Inc., 14401 West 65th Way, A Terminated |
NVZ | None listed |
| Dec 2, 2005 | ela Medical Llc ELA Rhapsody SR model 2210. A single chamber rate-responsive pacemaker that uses both minute ventilation and accelerometer sensors. Sterilization with Ethylene Oxide Gas. Sorin Group, ELA medical, Terminated |
DXY | None listed |
| Dec 2, 2005 | ela Medical Llc Symphony DR model 2550 and ELA Rhapsody DR model 2510. A dual chamber rate-responsive pacemaker that uses both minute ventilation and accelerometer sensors. Sterilization with Ethylene Oxide Gas. S Terminated |
DXY | None listed |
| Sep 24, 2005 | ela Medical Llc Alto MSP (model 617) and Alto 2 MSP (model 627) Implantable cardioverter Defibrillator. Ventricular antitachycardia pacing. Dual chamber arrhythmia detection. biventricular pacing. ELA medical 98, Terminated |
MRM | None listed |
| Sep 24, 2005 | ela Medical Llc Alto VR (model 615) and Alto 2 VR(model 625) Implantable cardioverter Defibrillator. Ventricular antichycardia pacing. Single chamber arrhythmia detection. Antibradycardia pacing. ELA medical 98, Terminated |
MRM | None listed |
| Sep 24, 2005 | ela Medical Llc Alto DR (model 614) and Alto 2 DR (model 624) Implantable cardioverter Defibrillator. Ventricular antichycardia pacing. Dual chamber arrhythmia detection. Antibradycardia pacing. ELA medical 98, r Terminated |
MRM | None listed |
| May 6, 2005 | ela Medical Llc Sentinel Implantable Carioverter-DefibrilIator (ICD) model 2012 is a multi-programmable, two-zone, tiered-therapy device that incorporates anti-tachycardia pacing (ATP), cardioversion, and defibrillat Terminated |
LWS | None listed |
| May 6, 2005 | ela Medical Llc Sentinel Implantable Carioverter-DefibrilIator (ICD) model 2010 is a multi-programmable, two-zone, tiered-therapy device that incorporates anti-tachycardia pacing (ATP), cardioversion, and defibrillat Terminated |
LWS | None listed |
| Nov 4, 2004 | ela Medical Llc Alto implantable cardioverter defibrillator Terminated |
LWS | None listed |