Company ยท US
Ceremed , Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2004 to 2016. Name variants (Inc, Corp, punctuation) are merged.
20510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 27, 2016 | K161446 | Biopor Porous Polyethylene Implants Ceremed , Inc. | GWO |
| Jul 14, 2016 | K160988 | Biopor, AOC Porous Polyethylene, Cerepor Ceremed , Inc. | KKY |
| Apr 16, 2015 | K141880 | BIOPOR AOC POROUS POLYETHYLENE, CEREPOR Ceremed , Inc. | KKY |
| Sep 12, 2013 | K132198 | ADAPTAIN, ADAPTAIN FASTWRAP, ENVELOCK, BIOWAI Ceremed , Inc. | KHJ |
| Nov 27, 2012 | K122561 | ADAPTAIN FASTWRAP, ENVELOCK, GRAFTAIN Ceremed , Inc. | KHJ |
| Jun 6, 2012 | K120220 | ADAPTAIN SOLUBLE IMPLANT MATERIAL Ceremed , Inc. | KHJ |
| Jan 5, 2011 | K103047 | CERETENE SOLUBLE IMPLANT MATERIAL Ceremed , Inc. | KHJ |
| Oct 8, 2010 | K102071 | OSTENE CT, AOC CT, OSTEOTENE, CERETENE Ceremed , Inc. | MTJ |
| Jun 22, 2009 | K091636 | OSTENE CT, AOC CT, OSTEOTENE, CERETENE Ceremed , Inc. | MTJ |
| Sep 24, 2008 | K082491 | OSTENE CT SOLUBLE BONE HEMOSTASIS IMPLANT MATERIAL, AOC CT, AOC, OSTENE, OSTEOTENE & CERETENE Ceremed , Inc. | MTJ |
| Sep 18, 2008 | K082245 | AOC, OSTENE, AOC IMPLANT MATERIAL, CERETENE, OSTENE LUBE, AOC-LV Ceremed , Inc. | KHJ |
| Jul 18, 2008 | K081531 | AOC SOLUBLE IMPLANT MATERIAL Ceremed , Inc. | KHJ |
| Apr 21, 2008 | K080507 | AOC POROUS POLYETHYLENE, AOC POROUS HDPE, AOC POROUS POLYETHYLENE SURGICAL IMPLANT Ceremed , Inc. | KKY |
| Jan 24, 2007 | K070093 | OSTENE, AOC, OSTEOTENE, CERETENE, CEREPOR, APTENE, APATENE, ACTIPASTE Ceremed , Inc. | KHJ |
| Dec 11, 2006 | K062280 | OSTENE, AOC, OSTEOTENE, CERETENE, CEREPOR, APTENE, APATENE AND ACTIPASTE Ceremed , Inc. | KHJ |
| Oct 11, 2005 | K052528 | AOC BONE WAX OSTENE, OSTEOTENE AND CERETENE Ceremed , Inc. | MTJ |
| Jun 14, 2005 | K051293 | CRANION CRANIAL FIXATION SYSTEM; FIXLOCK; CRANIAL SOLUTIONS; CEREMED FIXATION SYSTEM Ceremed , Inc. | JEY |
| Mar 24, 2005 | K050440 | AOC BONE WAX, OSTENE, OSTEOTENE, ORTHOSEAL, OSTEOSEAL, CERETENE, MODEL BW-12 Ceremed , Inc. | MTJ |
| Mar 2, 2005 | K043133 | AOC POROUS POLYETHYLENE, AOC POROUS HDPE, AOC POROUS POLYETHYLENE SURGICAL IMPLANT, CEREPOR Ceremed , Inc. | KKY |
| Jul 27, 2004 | K041363 | AOC BONE WAX Ceremed , Inc. | MTJ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||