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

FDA 510(k) Regulatory Record - Ela Medical, Inc. Cardiovascular ✕

42 devices

1-12 of 42

Cleared Oct 20, 2004

SYNESCOPE, EASYSCOPE, SYNECOM, HOLTERREADER

Cardiovascular · 86d

Cleared Aug 22, 2003

Cardiovascular · 11d

Cleared May 02, 2001

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 Jul 17, 1990

FOCUS J81F, J83F, J41F, J43F PACING LEADS

Cardiovascular · 229d

Cleared Apr 04, 1990

ELATEC HOLTER ANALYZER

Cardiovascular · 188d

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