FDA 510(k) Applications for Medical Device Product Code "KHJ"
(Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material))
FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K013243 |
BIOFORM, INC. |
COAPTITE LARYNGEAL AUGMENTATION SYSTEM 1CC & O.5CC, MODELS 0008021-1, 0008022-1 |
01/09/2002 |
K060561 |
CAMBRIDGEMED |
CLEARADEX GEL |
05/30/2006 |
K070093 |
CEREMED INC. |
OSTENE, AOC, OSTEOTENE, CERETENE, CEREPOR, APTENE, APATENE, ACTIPASTE |
01/24/2007 |
K122561 |
CEREMED, INC. |
ADAPTAIN FASTWRAP, ENVELOCK, GRAFTAIN |
11/27/2012 |
K120220 |
CEREMED, INC. |
ADAPTAIN SOLUBLE IMPLANT MATERIAL |
06/06/2012 |
K132198 |
CEREMED, INC. |
ADAPTAIN, ADAPTAIN FASTWRAP, ENVELOCK, BIOWAI |
09/12/2013 |
K081531 |
CEREMED, INC. |
AOC SOLUBLE IMPLANT MATERIAL |
07/18/2008 |
K082245 |
CEREMED, INC. |
AOC, OSTENE, AOC IMPLANT MATERIAL, CERETENE, OSTENE LUBE, AOC-LV |
09/18/2008 |
K103047 |
CEREMED, INC. |
CERETENE SOLUBLE IMPLANT MATERIAL |
01/05/2011 |
K062280 |
CEREMED, INC. |
OSTENE, AOC, OSTEOTENE, CERETENE, CEREPOR, APTENE, APATENE AND ACTIPASTE |
12/11/2006 |
K161000 |
COOK BIOTECH INCORPORATED |
Biodesign Otologic Repair Graft |
05/11/2016 |
K121360 |
COOK BIOTECH INCORPRATED |
BIODESIGN ENT REPAIR GRAFT |
02/27/2013 |
K150594 |
COOK BIOTECH INCORPRATED |
Biodesign Otologic Repair Graft |
09/16/2015 |
K051911 |
CURAMEDICAL, BV |
GELITA-SPON |
12/06/2005 |
K060878 |
CURAMEDICAL, BV |
GELITA-SPON ABSORBABLE GELATIN SPONGE, USP |
04/13/2006 |
K051487 |
DOCTOR'S RESEARCH GROUP, INC. |
DRG LARYNGEAL AUGMENTATION IMPLANT DEVICE |
12/22/2005 |
K972700 |
EXMOOR PLASTICS LTD. |
EXMOOR ATTIC AND MASTOID ANTRUM MIDDLE EAR IMPLANT (EMMETT CAMPBELL MD FACS PATTERN) |
07/16/1998 |
K003855 |
FIDIA ADVANCED BIOPOLYMERS SRL |
HYALOMATRIX CO |
07/03/2001 |
K043035 |
GENZYME CORPORATION |
SEPRAGEL ENT BIORESORBABLE PACKING/STENT |
07/11/2005 |
K974311 |
GYRUS ENT L.L.C. |
VOCOM (VOCAL CORD MEDIALIZATION) IMPLANT |
03/04/1998 |
K991324 |
HEINZ KURZ |
TITANIUM VOCAL FOLD MEDIALIZING IMPLANT, MODELS 5001 001 (FEMALE), AND 5001 003 (MALE) |
05/18/1999 |
K033796 |
HEINZ KURZ GMBH MEDIZINTECHNIK |
KURZ SILICONE STRIPS, MODELS SF-1, SF-1W, SF-1 BS |
01/30/2004 |
K002972 |
MEDTRONIC XOMED |
MEROGEL CONTROL GEL ENT SURGICAL DRESSING |
12/15/2000 |
K080022 |
VASCULAR SOLUTIONS, INC. |
GEL-SPONGE ENT, ABSORBABLE GELATIN SPONGE, USP |
12/09/2008 |
K982870 |
XOMED, INC. |
EPIFILM OTOLOGIC LAMINA |
11/03/1998 |
K964484 |
XOMED, INC. |
KARTUSH TM PATCHER |
01/24/1997 |
K001148 |
XOMED, INC. |
MEROGEL OTOLOGIC PACK |
06/03/2000 |
K970910 |
XOMED, INC. |
XOMED SILICONE BLOCK/STRIP |
05/02/1997 |
K982294 |
XOMED, INC. |
XOMED SILICONE PRE-FORM BLOCKS |
09/18/1998 |
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