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Ela Medical, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
43
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K042002SYNESCOPE, EASYSCOPE, SYNECOM, HOLTERREADEROctober 20, 2004
K032466SPIDERVIEWAugust 22, 2003
K002817SYNETECMay 2, 2001
K993448STELA UT46 AND BT45/46 STRAIGHT TINED PACING LEADS, STELA UJ45 AND BJ44/45 J-SHAPED TINED PACING LEAApril 10, 2000
K000029STELA UT46 AND BT45/46 STRAIGHT TINED PACING LEADS, STELA UJ45 AND BJ44/45 J-SHAPED TINED PACING LEAApril 4, 2000
K990727SYNEFLASH & SYNEVIEWNovember 26, 1999
K972574STELA MODEL UJ45 PACING LEADSJanuary 8, 1998
K970072OPUS S MODEL 4121 AND 4124 PACEMAKERSAugust 29, 1997
K963738STELA MODEL BJ44 AND BJ45 PACING LEADSMay 23, 1997
K952364OPUS PACEMAKERS (MODELS 4001, 4003, 4004, 4023, 4024)September 1, 1995
K952363OPUS PACEMAKERS (MODELS 4021, 4033, AND 4034)August 15, 1995
K896742FOCUS J81F, J83F, J41F, J43F PACING LEADSJuly 17, 1990
K895806ELATEC HOLTER ANALYZERApril 4, 1990
K900461OPUS MODEL 4021, VVI, 5MM UNIPOLARMarch 14, 1990
K894065OPUS MODEL 4001September 26, 1989
K894267OPUS MODELS 4033 AND 4034September 20, 1989
K890018PACEMAKER LEAD ADAPTERJune 20, 1989
K883037UNILITH 3 MODELS 7580/7583/7680/7683January 25, 1989
K884394PACING LEADS FOCUS T81,T81F,T82F,T83,T83F,T84FDecember 8, 1988
K882391OPUS 3 PULSE GENERATORS MODELS 4003,4004,4023,4024November 14, 1988