FDA Product Code
FDA Product Code KHJ — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Ear, Nose, Throat
- 21 CFR Citation
- 874.3620
510(k) Clearances — 34 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K260266 | Tympendi (810) | Grace Medical, Inc. | 2026-08-18 | Traditional | PDF ↗ |
| K232646 | Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.4-0.6); Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.6-0.9) | Cook Biotech Incorporated | 2024-05-24 | Traditional | PDF ↗ |
| K161000 | Biodesign Otologic Repair Graft | Cook Biotech Incorporated | 2016-05-11 | Special | PDF ↗ |
| K150594 | Biodesign Otologic Repair Graft | Cook Biotech Incorprated | 2015-09-16 | Traditional | PDF ↗ |
| K132198 | ADAPTAIN, ADAPTAIN FASTWRAP, ENVELOCK, BIOWAI | Ceremed , Inc. | 2013-09-12 | Traditional | PDF ↗ |
| K121360 | BIODESIGN ENT REPAIR GRAFT | Cook Biotech Incorprated | 2013-02-27 | Traditional | PDF ↗ |
| K122561 | ADAPTAIN FASTWRAP, ENVELOCK, GRAFTAIN | Ceremed , Inc. | 2012-11-27 | Traditional | PDF ↗ |
| K120220 | ADAPTAIN SOLUBLE IMPLANT MATERIAL | Ceremed , Inc. | 2012-06-06 | Traditional | PDF ↗ |
| K103047 | CERETENE SOLUBLE IMPLANT MATERIAL | Ceremed , Inc. | 2011-01-05 | Traditional | PDF ↗ |
| K080022 | GEL-SPONGE ENT, ABSORBABLE GELATIN SPONGE, USP | Vascular Solutions, Inc. | 2008-12-09 | Traditional | PDF ↗ |
| K082245 | AOC, OSTENE, AOC IMPLANT MATERIAL, CERETENE, OSTENE LUBE, AOC-LV | Ceremed , Inc. | 2008-09-18 | Traditional | PDF ↗ |
| K081531 | AOC SOLUBLE IMPLANT MATERIAL | Ceremed , Inc. | 2008-07-18 | Traditional | PDF ↗ |
| K070093 | OSTENE, AOC, OSTEOTENE, CERETENE, CEREPOR, APTENE, APATENE, ACTIPASTE | Ceremed , Inc. | 2007-01-24 | Special | PDF ↗ |
| K062280 | OSTENE, AOC, OSTEOTENE, CERETENE, CEREPOR, APTENE, APATENE AND ACTIPASTE | Ceremed , Inc. | 2006-12-11 | Traditional | PDF ↗ |
| K060561 | CLEARADEX GEL | Cambridgemed | 2006-05-30 | Traditional | PDF ↗ |
| K060878 | GELITA-SPON ABSORBABLE GELATIN SPONGE, USP | Curamedical, BV | 2006-04-13 | Special | PDF ↗ |
| K051487 | DRG LARYNGEAL AUGMENTATION IMPLANT DEVICE | Doctor'S Research Group, Inc. | 2005-12-22 | Traditional | PDF ↗ |
| K051911 | GELITA-SPON | Curamedical, BV | 2005-12-06 | Traditional | PDF ↗ |
| K043035 | SEPRAGEL ENT BIORESORBABLE PACKING/STENT | Genzyme Corporation | 2005-07-11 | Traditional | PDF ↗ |
| K033796 | KURZ SILICONE STRIPS, MODELS SF-1, SF-1W, SF-1 BS | Heinz Kurz GmbH Medizintechnik | 2004-01-30 | Traditional | PDF ↗ |
| K013243 | COAPTITE LARYNGEAL AUGMENTATION SYSTEM 1CC & O.5CC, MODELS 0008021-1, 0008022-1 | Bioform, Inc. | 2002-01-09 | Traditional | PDF ↗ |
| K003855 | HYALOMATRIX CO | Fidia Advanced Biopolymers Srl | 2001-07-03 | Traditional | PDF ↗ |
| K002972 | MEROGEL CONTROL GEL ENT SURGICAL DRESSING | Medtronic Xomed | 2000-12-15 | Traditional | PDF ↗ |
| K001148 | MEROGEL OTOLOGIC PACK | Xomed, Inc. | 2000-06-03 | Traditional | PDF ↗ |
| K991324 | TITANIUM VOCAL FOLD MEDIALIZING IMPLANT, MODELS 5001 001 (FEMALE), AND 5001 003 (MALE) | Heinz Kurz | 1999-05-18 | Traditional | PDF ↗ |
| K982870 | EPIFILM OTOLOGIC LAMINA | Xomed, Inc. | 1998-11-03 | Traditional | PDF ↗ |
| K982294 | XOMED SILICONE PRE-FORM BLOCKS | Xomed, Inc. | 1998-09-18 | Traditional | PDF ↗ |
| K972700 | EXMOOR ATTIC AND MASTOID ANTRUM MIDDLE EAR IMPLANT (EMMETT CAMPBELL MD FACS PATTERN) | Exmoor Plastics , Ltd. | 1998-07-16 | Traditional | PDF ↗ |
| K974311 | VOCOM (VOCAL CORD MEDIALIZATION) IMPLANT | Gyrus Ent LLC | 1998-03-04 | Traditional | PDF ↗ |
| K970910 | XOMED SILICONE BLOCK/STRIP | Xomed, Inc. | 1997-05-02 | Traditional | PDF ↗ |
| K964484 | KARTUSH TM PATCHER | Xomed, Inc. | 1997-01-24 | Traditional | PDF ↗ |
| K953013 | MEROCEL REINFORCED SILICONE SHEETS | Merocel Corp. | 1995-08-29 | Traditional | PDF ↗ |
| K932176 | BIOSIL MEDICAL GRADE SILICONE SHEETING | Bioplexus Corp. | 1993-12-02 | Traditional | PDF ↗ |
| K911503 | EXMOOR SILICONE RUBBER SHEET | Exmoor Plastics , Ltd. | 1991-11-19 | Traditional | PDF ↗ |
Product code KHJ · Class II · Ear, Nose, Throat. Data: openFDA.