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Ela Medical, Inc.

FDA 510(k) & PMA Approved Devices — 43 products

Total Devices43
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K042002 SYNESCOPE, EASYSCOPE, SYNECOM, HOLTERREADERDQK2004-10-20 View
510(k) K032466 SPIDERVIEWMWJ2003-08-22 View
510(k) K002817 SYNETECDQK2001-05-02 View
510(k) K993448 STELA UT46 AND BT45/46 STRAIGHT TINED PACING LEADS, STELA UJ45 AND BJ44/45 J-SHAPED TINED PACING LEADSDTB2000-04-10 View
510(k) K000029 STELA UT46 AND BT45/46 STRAIGHT TINED PACING LEADS, STELA UJ45 AND BJ44/45 J-SHAPED TINED PACING LEADSDTB2000-04-04 View
510(k) K990727 SYNEFLASH & SYNEVIEWDQK1999-11-26 View
510(k) K972574 STELA MODEL UJ45 PACING LEADSDTB1998-01-08 View
510(k) K970072 OPUS S MODEL 4121 AND 4124 PACEMAKERSDXY1997-08-29 View
510(k) K963738 STELA MODEL BJ44 AND BJ45 PACING LEADSDTB1997-05-23 View
510(k) K952364 OPUS PACEMAKERS (MODELS 4001, 4003, 4004, 4023, 4024)DXY1995-09-01 View
510(k) K952363 OPUS PACEMAKERS (MODELS 4021, 4033, AND 4034)ELA1995-08-15 View
510(k) K896742 FOCUS J81F, J83F, J41F, J43F PACING LEADSDTB1990-07-17 View
510(k) K895806 ELATEC HOLTER ANALYZERDSI1990-04-04 View
510(k) K900461 OPUS MODEL 4021, VVI, 5MM UNIPOLARDXY1990-03-14 View
510(k) K894065 OPUS MODEL 4001DXY1989-09-26 View
510(k) K894267 OPUS MODELS 4033 AND 4034DXY1989-09-20 View
510(k) K890018 PACEMAKER LEAD ADAPTERDTB1989-06-20 View
510(k) K883037 UNILITH 3 MODELS 7580/7583/7680/7683DXY1989-01-25 View
510(k) K884394 PACING LEADS FOCUS T81,T81F,T82F,T83,T83F,T84FDTB1988-12-08 View
510(k) K882391 OPUS 3 PULSE GENERATORS MODELS 4003,4004,4023,4024DXY1988-11-14 View
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