Medical Device Manufacturer · US , Los Angeles , CA

Ceremed , Inc.

20 submissions · 20 cleared · Since 2004
20
Total
20
Cleared
0
Denied

Ceremed , Inc. — FDA 510(k) Submissions

Ceremed , Inc. has submitted 20 FDA 510(k) premarket notifications since 2004, of which 20 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Polymer, Ent Synthetic-polyamide (mesh Or Foil Material), Wax, Bone, Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction, Plate, Bone, Plate, Cranioplasty, Preformed, Alterable . Use the specialty filter in the sidebar to narrow results.

20 devices
1–20 of 20
Biopor Porous Polyethylene Implants
K161446 · GWO Plate, Cranioplasty,... · Neurology
Sep 2016 125d
Biopor, AOC Porous Polyethylene, Cerepor
K160988 · KKY Material,... · General & Plastic Surgery
Jul 2016 97d
BIOPOR AOC POROUS POLYETHYLENE, CEREPOR
K141880 · KKY Material,... · General & Plastic Surgery
Apr 2015 279d
ADAPTAIN, ADAPTAIN FASTWRAP, ENVELOCK, BIOWAI
K132198 · KHJ Polymer, Ent... · Ear, Nose, Throat
Sep 2013 58d
ADAPTAIN FASTWRAP, ENVELOCK, GRAFTAIN
K122561 · KHJ Polymer, Ent... · Ear, Nose, Throat
Nov 2012 97d
ADAPTAIN SOLUBLE IMPLANT MATERIAL
K120220 · KHJ Polymer, Ent... · Ear, Nose, Throat
Jun 2012 133d
CERETENE SOLUBLE IMPLANT MATERIAL
K103047 · KHJ Polymer, Ent... · Ear, Nose, Throat
Jan 2011 82d
OSTENE CT, AOC CT, OSTEOTENE, CERETENE
K102071 · MTJ Wax, Bone · General & Plastic Surgery
Oct 2010 77d
OSTENE CT, AOC CT, OSTEOTENE, CERETENE
K091636 · MTJ Wax, Bone · General & Plastic Surgery
Jun 2009 18d
OSTENE CT SOLUBLE BONE HEMOSTASIS IMPLANT MATERIAL, AOC CT, AOC, OSTENE, OSTEOTENE & CERETENE
K082491 · MTJ Wax, Bone · General & Plastic Surgery
Sep 2008 27d
AOC, OSTENE, AOC IMPLANT MATERIAL, CERETENE, OSTENE LUBE, AOC-LV
K082245 · KHJ Polymer, Ent... · Ear, Nose, Throat
Sep 2008 42d
AOC SOLUBLE IMPLANT MATERIAL
K081531 · KHJ Polymer, Ent... · Ear, Nose, Throat
Jul 2008 46d
AOC POROUS POLYETHYLENE, AOC POROUS HDPE, AOC POROUS POLYETHYLENE SURGICAL IMPLANT
K080507 · KKY Material,... · General & Plastic Surgery
Apr 2008 56d
OSTENE, AOC, OSTEOTENE, CERETENE, CEREPOR, APTENE, APATENE, ACTIPASTE
K070093 · KHJ Polymer, Ent... · Ear, Nose, Throat
Jan 2007 14d
OSTENE, AOC, OSTEOTENE, CERETENE, CEREPOR, APTENE, APATENE AND ACTIPASTE
K062280 · KHJ Polymer, Ent... · Ear, Nose, Throat
Dec 2006 126d
AOC BONE WAX OSTENE, OSTEOTENE AND CERETENE
K052528 · MTJ Wax, Bone · General & Plastic Surgery
Oct 2005 27d
CRANION CRANIAL FIXATION SYSTEM; FIXLOCK; CRANIAL SOLUTIONS; CEREMED FIXATION SYSTEM
K051293 · JEY Plate, Bone · Dental
Jun 2005 27d
AOC BONE WAX, OSTENE, OSTEOTENE, ORTHOSEAL, OSTEOSEAL, CERETENE, MODEL BW-12
K050440 · MTJ Wax, Bone · General & Plastic Surgery
Mar 2005 30d
AOC POROUS POLYETHYLENE, AOC POROUS HDPE, AOC POROUS POLYETHYLENE SURGICAL IMPLANT, CEREPOR
K043133 · KKY Material,... · General & Plastic Surgery
Mar 2005 110d
AOC BONE WAX
K041363 · MTJ Wax, Bone · General & Plastic Surgery
Jul 2004 67d
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