Medical Device Manufacturer · US , Mchenry , IL

Ela Medical, Inc.

43 submissions · 36 cleared · Since 1979
43
Total
36
Cleared
0
Denied

Ela Medical, Inc. — FDA 510(k) Submissions

Ela Medical, Inc. has submitted 43 FDA 510(k) premarket notifications since 1979, of which 36 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Implantable Pacemaker Pulse-generator, Permanent Pacemaker Electrode, Computer, Diagnostic, Programmable, Analyzer, Pacemaker Generator Function, Electrocardiograph, Ambulatory (without Analysis) . Use the specialty filter in the sidebar to narrow results.

43 devices
1–25 of 43
SYNESCOPE, EASYSCOPE, SYNECOM, HOLTERREADER
K042002 · DQK Computer, Diagnostic,... · Cardiovascular
Oct 2004 86d
SPIDERVIEW
K032466 · MWJ Electrocardiograph,... · Cardiovascular
Aug 2003 11d
SYNETEC
K002817 · DQK Computer, Diagnostic,... · Cardiovascular
May 2001 233d
STELA UT46 AND BT45/46 STRAIGHT TINED PACING LEADS, STELA UJ45 AND BJ44/45 J-SHAPED TINED PACING LEADS
K993448 · DTB Permanent Pacemaker... · Cardiovascular
Apr 2000 181d
STELA UT46 AND BT45/46 STRAIGHT TINED PACING LEADS, STELA UJ45 AND BJ44/45 J-SHAPED TINED PACING LEADS
K000029 · DTB Permanent Pacemaker... · Cardiovascular
Apr 2000 90d
SYNEFLASH & SYNEVIEW
K990727 · DQK Computer, Diagnostic,... · Cardiovascular
Nov 1999 266d
STELA MODEL UJ45 PACING LEADS
K972574 · DTB Permanent Pacemaker... · Cardiovascular
Jan 1998 182d
OPUS S MODEL 4121 AND 4124 PACEMAKERS
K970072 · DXY Implantable Pacemaker... · Cardiovascular
Aug 1997 233d
STELA MODEL BJ44 AND BJ45 PACING LEADS
K963738 · DTB Permanent Pacemaker... · Cardiovascular
May 1997 248d
OPUS PACEMAKERS (MODELS 4001, 4003, 4004, 4023, 4024)
K952364 · DXY Implantable Pacemaker... · Cardiovascular
Sep 1995 123d
OPUS PACEMAKERS (MODELS 4021, 4033, AND 4034)
K952363 · ELA Instrument, Hand,... · Dental
Aug 1995 106d
FOCUS J81F, J83F, J41F, J43F PACING LEADS
K896742 · DTB Permanent Pacemaker... · Cardiovascular
Jul 1990 229d
ELATEC HOLTER ANALYZER
K895806 · DSI Detector And Alarm,... · Cardiovascular
Apr 1990 188d
OPUS MODEL 4021, VVI, 5MM UNIPOLAR
K900461 · DXY Implantable Pacemaker... · Cardiovascular
Mar 1990 42d
OPUS MODEL 4001
K894065 · DXY Implantable Pacemaker... · Cardiovascular
Sep 1989 110d
OPUS MODELS 4033 AND 4034
K894267 · DXY Implantable Pacemaker... · Cardiovascular
Sep 1989 90d
PACEMAKER LEAD ADAPTER
K890018 · DTB Permanent Pacemaker... · Cardiovascular
Jun 1989 168d
UNILITH 3 MODELS 7580/7583/7680/7683
K883037 · DXY Implantable Pacemaker... · Cardiovascular
Jan 1989 190d
PACING LEADS FOCUS T81,T81F,T82F,T83,T83F,T84F
K884394 · DTB Permanent Pacemaker... · Cardiovascular
Dec 1988 55d
OPUS 3 PULSE GENERATORS MODELS 4003,4004,4023,4024
K882391 · DXY Implantable Pacemaker... · Cardiovascular
Nov 1988 157d
CARDIAC PACE. OPUS 4000 MODELS 4043/4044/4063/4066
K882427 · DXY Implantable Pacemaker... · Cardiovascular
Sep 1988 102d
OPUS PULSE GENERATORS MODELS 2001, 2003 AND 2004
K882474 · DXY Implantable Pacemaker... · Cardiovascular
Sep 1988 89d
OPUS PULSE GENERATORS MODELS 3001, 3003 AND 3004
K882476 · DXY Implantable Pacemaker... · Cardiovascular
Sep 1988 89d
PICF 0860/PSCF 0860/PSC 0860/PIAF 0860/PSAF 0860
K872731 · DTB Permanent Pacemaker... · Cardiovascular
Sep 1987 69d
MULTILITH 3 MODELS 1350, 3350, 1370, 3370
K863898 · DXY Implantable Pacemaker... · Cardiovascular
Feb 1987 126d
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