Panels › Ear, Nose, Throat › Product code KHJ · Class 2
Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)
Regulation 874.3620
1510(k)s in 12 months (34 all time)
0recalls in 12 months (2 all time)
2recalls that name a 510(k)
Top companies in KHJ
| Company | 510(k)s | Recalls |
|---|---|---|
| Ceremed , Inc. | 8 | 0 |
| Xomed, Inc. | 5 | 0 |
| Cook Biotech Incorporated | 2 | 1 |
| Cook Biotech Incorprated | 2 | 0 |
| Curamedical, BV | 2 | 0 |
| Exmoor Plastics , Ltd. | 2 | 0 |
| Bioform, Inc. | 1 | 0 |
| Bioplexus Corp. | 1 | 0 |
| Cambridgemed | 1 | 0 |
| Doctor'S Research Group, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 18, 2026 | K260266 | Tympendi (810) Grace Medical, Inc. | KHJ |
| May 24, 2024 | 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 | KHJ |
| May 11, 2016 | K161000 | Biodesign Otologic Repair Graft Cook Biotech Incorporated | KHJ |
| Sep 16, 2015 | K150594 | Biodesign Otologic Repair Graft Cook Biotech Incorprated | KHJ |
| Sep 12, 2013 | K132198 | ADAPTAIN, ADAPTAIN FASTWRAP, ENVELOCK, BIOWAI Ceremed , Inc. | KHJ |
| Feb 27, 2013 | K121360 | BIODESIGN ENT REPAIR GRAFT Cook Biotech Incorprated | KHJ |
| Nov 27, 2012 | K122561 | ADAPTAIN FASTWRAP, ENVELOCK, GRAFTAIN Ceremed , Inc. | KHJ |
| Jun 6, 2012 | K120220 | ADAPTAIN SOLUBLE IMPLANT MATERIAL Ceremed , Inc. | KHJ |
| Jan 5, 2011 | K103047 | CERETENE SOLUBLE IMPLANT MATERIAL Ceremed , Inc. | KHJ |
| Dec 9, 2008 | K080022 | GEL-SPONGE ENT, ABSORBABLE GELATIN SPONGE, USP Vascular Solutions, Inc. | KHJ |
| Sep 18, 2008 | K082245 | AOC, OSTENE, AOC IMPLANT MATERIAL, CERETENE, OSTENE LUBE, AOC-LV Ceremed , Inc. | KHJ |
| Jul 18, 2008 | K081531 | AOC SOLUBLE IMPLANT MATERIAL Ceremed , Inc. | KHJ |
| Jan 24, 2007 | K070093 | OSTENE, AOC, OSTEOTENE, CERETENE, CEREPOR, APTENE, APATENE, ACTIPASTE Ceremed , Inc. | KHJ |
| Dec 11, 2006 | K062280 | OSTENE, AOC, OSTEOTENE, CERETENE, CEREPOR, APTENE, APATENE AND ACTIPASTE Ceremed , Inc. | KHJ |
| May 30, 2006 | K060561 | CLEARADEX GEL Cambridgemed | KHJ |
| Apr 13, 2006 | K060878 | GELITA-SPON ABSORBABLE GELATIN SPONGE, USP Curamedical, BV | KHJ |
| Dec 22, 2005 | K051487 | DRG LARYNGEAL AUGMENTATION IMPLANT DEVICE Doctor'S Research Group, Inc. | KHJ |
| Dec 6, 2005 | K051911 | GELITA-SPON Curamedical, BV | KHJ |
| Jul 11, 2005 | K043035 | SEPRAGEL ENT BIORESORBABLE PACKING/STENT Genzyme Corporation | KHJ |
| Jan 30, 2004 | K033796 | KURZ SILICONE STRIPS, MODELS SF-1, SF-1W, SF-1 BS Heinz Kurz GmbH Medizintechnik, NL | KHJ |
| Jan 9, 2002 | K013243 | COAPTITE LARYNGEAL AUGMENTATION SYSTEM 1CC & O.5CC, MODELS 0008021-1, 0008022-1 Bioform, Inc. | KHJ |
| Jul 3, 2001 | K003855 | HYALOMATRIX CO Fidia Advanced Biopolymers Srl, IT | KHJ |
| Dec 15, 2000 | K002972 | MEROGEL CONTROL GEL ENT SURGICAL DRESSING Medtronic Xomed | KHJ |
| Jun 3, 2000 | K001148 | MEROGEL OTOLOGIC PACK Xomed, Inc. | KHJ |
| May 18, 1999 | K991324 | TITANIUM VOCAL FOLD MEDIALIZING IMPLANT, MODELS 5001 001 (FEMALE), AND 5001 003 (MALE) Heinz Kurz, DE | KHJ |
| Nov 3, 1998 | K982870 | EPIFILM OTOLOGIC LAMINA Xomed, Inc. | KHJ |
| Sep 18, 1998 | K982294 | XOMED SILICONE PRE-FORM BLOCKS Xomed, Inc. | KHJ |
| Jul 16, 1998 | K972700 | EXMOOR ATTIC AND MASTOID ANTRUM MIDDLE EAR IMPLANT (EMMETT CAMPBELL MD FACS PATTERN) Exmoor Plastics , Ltd., GB | KHJ |
| Mar 4, 1998 | K974311 | VOCOM (VOCAL CORD MEDIALIZATION) IMPLANT Gyrus Ent LLC | KHJ |
| May 2, 1997 | K970910 | XOMED SILICONE BLOCK/STRIP Xomed, Inc. | KHJ |
| Jan 24, 1997 | K964484 | KARTUSH TM PATCHER Xomed, Inc. | KHJ |
| Aug 29, 1995 | K953013 | MEROCEL REINFORCED SILICONE SHEETS Merocel Corp. | KHJ |
| Dec 2, 1993 | K932176 | BIOSIL MEDICAL GRADE SILICONE SHEETING Bioplexus Corp. | KHJ |
| Nov 19, 1991 | K911503 | EXMOOR SILICONE RUBBER SHEET Exmoor Plastics , Ltd., GB | KHJ |
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