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 |
| K232646 | Cook Biotech Incorporated | Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.4-0.6); Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.6-0.9) | 05/24/2024 |
| 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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