Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)
FDA product code KHJ · 33 cleared devices
Class 2
Ear, Nose, Throat
- Regulation
- 21 CFR 874.3620
- Review panel
- EN
- Implant
- Yes
- Life sustaining
- No
- Third party review
- No
- GMP exempt
- No
- Clearance span
- 1991-11-19 – 2026-08-18
KHJ
2026-08-18
KHJ
2024-05-24
Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.4-0.6); Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.6-0.9)
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KHJ
2016-05-11
Biodesign Otologic Repair Graft
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KHJ
2013-09-12
ADAPTAIN, ADAPTAIN FASTWRAP, ENVELOCK, BIOWAI
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KHJ
2013-02-27
BIODESIGN ENT REPAIR GRAFT
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KHJ
2012-11-27
ADAPTAIN FASTWRAP, ENVELOCK, GRAFTAIN
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KHJ
2012-06-06
ADAPTAIN SOLUBLE IMPLANT MATERIAL
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KHJ
2011-01-05
CERETENE SOLUBLE IMPLANT MATERIAL
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KHJ
2008-12-09
GEL-SPONGE ENT, ABSORBABLE GELATIN SPONGE, USP
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KHJ
2008-09-18
AOC, OSTENE, AOC IMPLANT MATERIAL, CERETENE, OSTENE LUBE, AOC-LV
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KHJ
2008-07-18
AOC SOLUBLE IMPLANT MATERIAL
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KHJ
2007-01-24
OSTENE, AOC, OSTEOTENE, CERETENE, CEREPOR, APTENE, APATENE, ACTIPASTE
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KHJ
2006-12-11
OSTENE, AOC, OSTEOTENE, CERETENE, CEREPOR, APTENE, APATENE AND ACTIPASTE
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KHJ
2006-05-30
CLEARADEX GEL
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KHJ
2006-04-13
GELITA-SPON ABSORBABLE GELATIN SPONGE, USP
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KHJ
2005-12-22
DRG LARYNGEAL AUGMENTATION IMPLANT DEVICE
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KHJ
2005-12-06
GELITA-SPON
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KHJ
2005-07-11
SEPRAGEL ENT BIORESORBABLE PACKING/STENT
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KHJ
2004-01-30
KURZ SILICONE STRIPS, MODELS SF-1, SF-1W, SF-1 BS
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KHJ
2002-01-09
COAPTITE LARYNGEAL AUGMENTATION SYSTEM 1CC & O.5CC, MODELS 0008021-1, 0008022-1
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KHJ
2001-07-03
HYALOMATRIX CO
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KHJ
2000-12-15
MEROGEL CONTROL GEL ENT SURGICAL DRESSING
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KHJ
2000-06-03
MEROGEL OTOLOGIC PACK
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KHJ
1999-05-18
TITANIUM VOCAL FOLD MEDIALIZING IMPLANT, MODELS 5001 001 (FEMALE), AND 5001 003 (MALE)
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KHJ
1998-11-03
EPIFILM OTOLOGIC LAMINA
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KHJ
1998-09-18
XOMED SILICONE PRE-FORM BLOCKS
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KHJ
1998-07-16
EXMOOR ATTIC AND MASTOID ANTRUM MIDDLE EAR IMPLANT (EMMETT CAMPBELL MD FACS PATTERN)
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KHJ
1998-03-04
VOCOM (VOCAL CORD MEDIALIZATION) IMPLANT
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KHJ
1997-05-02
XOMED SILICONE BLOCK/STRIP
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KHJ
1997-01-24
KARTUSH TM PATCHER
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KHJ
1995-08-29
MEROCEL REINFORCED SILICONE SHEETS
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KHJ
1993-12-02
BIOSIL MEDICAL GRADE SILICONE SHEETING
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KHJ
1991-11-19
EXMOOR SILICONE RUBBER SHEET
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