Ela Medical, Inc. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Ela Medical, Inc. - FDA 510(k) Cleared Devices
43
Total
36
Cleared
0
Denied
Ela Medical, Inc. has 36 FDA 510(k) cleared cardiovascular devices. Based in Mchenry, US.
Historical record: 36 cleared submissions from 1979 to 2004.
Browse the complete list of FDA 510(k) cleared cardiovascular devices from this manufacturer. Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Ela Medical, Inc.
43 devices
Cleared
Oct 20, 2004
SYNESCOPE, EASYSCOPE, SYNECOM, HOLTERREADER
Cardiovascular
86d
Cleared
Aug 22, 2003
SPIDERVIEW
Cardiovascular
11d
Cleared
May 02, 2001
SYNETEC
Cardiovascular
233d
Cleared
Apr 10, 2000
STELA UT46 AND BT45/46 STRAIGHT TINED PACING LEADS, STELA UJ45 AND BJ44/45...
Cardiovascular
181d
Cleared
Apr 04, 2000
STELA UT46 AND BT45/46 STRAIGHT TINED PACING LEADS, STELA UJ45 AND BJ44/45...
Cardiovascular
90d
Cleared
Nov 26, 1999
SYNEFLASH & SYNEVIEW
Cardiovascular
266d
Cleared
Jan 08, 1998
STELA MODEL UJ45 PACING LEADS
Cardiovascular
182d
Cleared
Aug 29, 1997
OPUS S MODEL 4121 AND 4124 PACEMAKERS
Cardiovascular
233d
Not Cleared
May 23, 1997
STELA MODEL BJ44 AND BJ45 PACING LEADS
Cardiovascular
248d
Cleared
Sep 01, 1995
OPUS PACEMAKERS (MODELS 4001, 4003, 4004, 4023, 4024)
Cardiovascular
123d
Cleared
Aug 15, 1995
OPUS PACEMAKERS (MODELS 4021, 4033, AND 4034)
Dental
106d
Cleared
Jul 17, 1990
FOCUS J81F, J83F, J41F, J43F PACING LEADS
Cardiovascular
229d
Looking for a specific device from Ela Medical, Inc.? Search by device name or K-number.
Search all Ela Medical, Inc. devices