Satelec

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
24
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K110379AIR-N-GODecember 8, 2011
K100410PIEZOELECTRIC SYSTEMApril 28, 2010
K091331PIEZOTOME 2December 11, 2009
K091252IMPLANT CENTER 2July 22, 2009
K082116HEMOSTASYL PASTEDecember 17, 2008
K072181MINI LED AUTOFOCUSSeptember 19, 2007
K071965I-SURGESeptember 10, 2007
K060275PIEZOTOMEMay 3, 2006
K060274PIEZOTOMEMay 1, 2006
K053328BIOSPLINT SPLINTING RIBBONJanuary 25, 2006
K050895SURPASSON P5 NEWTRONApril 20, 2005
K042787IS 40 MICROMOTORDecember 17, 2004
K040529COCOON HYGIENISTAugust 19, 2004
K040808MINI L.E.D. OEM MODULEApril 28, 2004
K033764SP NEWTRON MODULEMarch 1, 2004
K032465MINI L.E.D., MODEL: MINI L.E.D., MODEL SMARTLITE MINIOctober 21, 2003
K011001TEAM-UP TM DENTAL ELECTRONIC ANESTHESIA SYSTEMJune 7, 2001
K000049SUNI MAXApril 4, 2000
K972612DISSECTRON PORTABLE UNITOctober 8, 1997
K972026SP4044 & SP4055 LUX MODULESJuly 9, 1997