Medical Device Manufacturer · US , Mchenry , IL

Ela Medical, Inc. - FDA 510(k) Cleared Devices

43 submissions · 36 cleared · Since 1979
43
Total
36
Cleared
0
Denied
43 devices
26-43 of 43
Cleared Mar 31, 1986
UNILITH 2 PULSE GENERATORS #7550, 7552, 7760, 7762
K852973 · DXY
Cardiovascular · 259d
Cleared Aug 29, 1985
ELA MEDICAL PACING LEADS PMC 860 PMCF 860 PBCF860
K851731 · DTB
Cardiovascular · 126d
Cleared Jul 25, 1985
ELA MEDICAL CARDIAC PACEMAKERS MULTIL 2 #1251&2251
K853017 · DXY
Cardiovascular · 8d
Cleared Jan 10, 1985
MULTILITH PULSE GENERATORS, 1141 & 2141
K842193 · DXY
Cardiovascular · 220d
Cleared Nov 29, 1984
MULTILITH 2 PULSE GENERATOR 1141 & 2141
K842220 · DXY
Cardiovascular · 177d
Cleared Mar 17, 1983
UNILITH PULSE GENERATOR VVI #7542
K830401 · DXY
Cardiovascular · 38d
Cleared Mar 17, 1983
PACING LEAD #PMA F 860
K830457 · DTB
Cardiovascular · 36d
Cleared Feb 12, 1982
MEDICAL MULTILITH PULSE GENERA-1140
K813246 · DXY
Cardiovascular · 86d
Cleared Jul 20, 1981
ELA MEDICAL UNILITH 7540 PULSE GENERATOR
K810887 · DXY
Cardiovascular · 110d
Cleared May 29, 1981
ELA MEDICAL UNILITH PULSE GENERATOR
K810142 · DXY
Cardiovascular · 128d
Cleared May 29, 1981
MULTILITH PULSE GENERATOR #1140
K810489 · DXY
Cardiovascular · 95d
Cleared Mar 09, 1981
ELA MEDICAL PACING LEAD MODEL PMA 860
K810626
Cardiovascular
Cleared Mar 25, 1980
SUSI II PACEMAKER SURVEILLANCE MONITOR
K792602 · DTC
Cardiovascular · 98d
Cleared Jan 31, 1980
PACING SYSTEM ANALYZER PSA SCE-22
K791975 · DTC
Cardiovascular · 121d
Cleared Nov 07, 1979
ELA MEDICAL ANATEC HOLTER SCANNER
K792239
Cardiovascular
Cleared Jul 30, 1979
UNILITH PULSE GENERATOR
K791219 · DXY
Cardiovascular · 27d
Cleared May 08, 1979
PULSE GENERATOR MODEL 61 AND 128
K790562 · DXY
Cardiovascular · 50d
Cleared Apr 03, 1979
LEAD MODELS MUM 1260, MUM 1290
K790386 · DTB
Cardiovascular · 36d
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