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Ceremed , Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
20
Inspections
1
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K161446Biopor Porous Polyethylene ImplantsSeptember 27, 2016
K160988Biopor, AOC Porous Polyethylene, CereporJuly 14, 2016
K141880BIOPOR AOC POROUS POLYETHYLENE, CEREPORApril 16, 2015
K132198ADAPTAIN, ADAPTAIN FASTWRAP, ENVELOCK, BIOWAISeptember 12, 2013
K122561ADAPTAIN FASTWRAP, ENVELOCK, GRAFTAINNovember 27, 2012
K120220ADAPTAIN SOLUBLE IMPLANT MATERIALJune 6, 2012
K103047CERETENE SOLUBLE IMPLANT MATERIALJanuary 5, 2011
K102071OSTENE CT, AOC CT, OSTEOTENE, CERETENEOctober 8, 2010
K091636OSTENE CT, AOC CT, OSTEOTENE, CERETENEJune 22, 2009
K082491OSTENE CT SOLUBLE BONE HEMOSTASIS IMPLANT MATERIAL, AOC CT, AOC, OSTENE, OSTEOTENE & CERETENESeptember 24, 2008
K082245AOC, OSTENE, AOC IMPLANT MATERIAL, CERETENE, OSTENE LUBE, AOC-LVSeptember 18, 2008
K081531AOC SOLUBLE IMPLANT MATERIALJuly 18, 2008
K080507AOC POROUS POLYETHYLENE, AOC POROUS HDPE, AOC POROUS POLYETHYLENE SURGICAL IMPLANTApril 21, 2008
K070093OSTENE, AOC, OSTEOTENE, CERETENE, CEREPOR, APTENE, APATENE, ACTIPASTEJanuary 24, 2007
K062280OSTENE, AOC, OSTEOTENE, CERETENE, CEREPOR, APTENE, APATENE AND ACTIPASTEDecember 11, 2006
K052528AOC BONE WAX OSTENE, OSTEOTENE AND CERETENEOctober 11, 2005
K051293CRANION CRANIAL FIXATION SYSTEM; FIXLOCK; CRANIAL SOLUTIONS; CEREMED FIXATION SYSTEMJune 14, 2005
K050440AOC BONE WAX, OSTENE, OSTEOTENE, ORTHOSEAL, OSTEOSEAL, CERETENE, MODEL BW-12March 24, 2005
K043133AOC POROUS POLYETHYLENE, AOC POROUS HDPE, AOC POROUS POLYETHYLENE SURGICAL IMPLANT, CEREPORMarch 2, 2005
K041363AOC BONE WAXJuly 27, 2004