Atlas FDA

KHJ

33 FDA 510(k) clearances · Product code

88 daysmedian time to decision
268 days90th percentile
33clearances measured

FDA profile

Official device name
Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)
Device class
Class II (moderate risk)
Regulation
21 CFR 874.3620
Medical specialty
Ear, Nose, Throat
Flags
Implant
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RecordFirmDate
Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.4-0.6); Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.6-0.9) (K232646)Cook Biotech Incorporated2024-05-24
Biodesign Otologic Repair Graft (K161000)Cook Biotech Incorporated2016-05-11
Biodesign Otologic Repair Graft (K150594)Cook Biotech Incorprated2015-09-16
ADAPTAIN, ADAPTAIN FASTWRAP, ENVELOCK, BIOWAI (K132198)Ceremed , Inc.2013-09-12
BIODESIGN ENT REPAIR GRAFT (K121360)Cook Biotech Incorprated2013-02-27
ADAPTAIN FASTWRAP, ENVELOCK, GRAFTAIN (K122561)Ceremed , Inc.2012-11-27
ADAPTAIN SOLUBLE IMPLANT MATERIAL (K120220)Ceremed , Inc.2012-06-06
CERETENE SOLUBLE IMPLANT MATERIAL (K103047)Ceremed , Inc.2011-01-05
GEL-SPONGE ENT, ABSORBABLE GELATIN SPONGE, USP (K080022)Vascular Solutions, Inc.2008-12-09
AOC, OSTENE, AOC IMPLANT MATERIAL, CERETENE, OSTENE LUBE, AOC-LV (K082245)Ceremed , Inc.2008-09-18
AOC SOLUBLE IMPLANT MATERIAL (K081531)Ceremed , Inc.2008-07-18
OSTENE, AOC, OSTEOTENE, CERETENE, CEREPOR, APTENE, APATENE, ACTIPASTE (K070093)Ceremed , Inc.2007-01-24
OSTENE, AOC, OSTEOTENE, CERETENE, CEREPOR, APTENE, APATENE AND ACTIPASTE (K062280)Ceremed , Inc.2006-12-11
CLEARADEX GEL (K060561)Cambridgemed2006-05-30
GELITA-SPON ABSORBABLE GELATIN SPONGE, USP (K060878)Curamedical, BV2006-04-13
DRG LARYNGEAL AUGMENTATION IMPLANT DEVICE (K051487)Doctor'S Research Group, Inc.2005-12-22
GELITA-SPON (K051911)Curamedical, BV2005-12-06
SEPRAGEL ENT BIORESORBABLE PACKING/STENT (K043035)Genzyme Corporation2005-07-11
KURZ SILICONE STRIPS, MODELS SF-1, SF-1W, SF-1 BS (K033796)Heinz Kurz GmbH Medizintechnik2004-01-30
COAPTITE LARYNGEAL AUGMENTATION SYSTEM 1CC & O.5CC, MODELS 0008021-1, 0008022-1 (K013243)Bioform, Inc.2002-01-09
HYALOMATRIX CO (K003855)Fidia Advanced Biopolymers Srl2001-07-03
MEROGEL CONTROL GEL ENT SURGICAL DRESSING (K002972)Medtronic Xomed2000-12-15
MEROGEL OTOLOGIC PACK (K001148)Xomed, Inc.2000-06-03
TITANIUM VOCAL FOLD MEDIALIZING IMPLANT, MODELS 5001 001 (FEMALE), AND 5001 003 (MALE) (K991324)Heinz Kurz1999-05-18
EPIFILM OTOLOGIC LAMINA (K982870)Xomed, Inc.1998-11-03
XOMED SILICONE PRE-FORM BLOCKS (K982294)Xomed, Inc.1998-09-18
EXMOOR ATTIC AND MASTOID ANTRUM MIDDLE EAR IMPLANT (EMMETT CAMPBELL MD FACS PATTERN) (K972700)Exmoor Plastics , Ltd.1998-07-16
VOCOM (VOCAL CORD MEDIALIZATION) IMPLANT (K974311)Gyrus Ent LLC1998-03-04
XOMED SILICONE BLOCK/STRIP (K970910)Xomed, Inc.1997-05-02
KARTUSH TM PATCHER (K964484)Xomed, Inc.1997-01-24
MEROCEL REINFORCED SILICONE SHEETS (K953013)Merocel Corp.1995-08-29
BIOSIL MEDICAL GRADE SILICONE SHEETING (K932176)Bioplexus Corp.1993-12-02
EXMOOR SILICONE RUBBER SHEET (K911503)Exmoor Plastics , Ltd.1991-11-19

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Every clearance here is in the API, with alerts when new ones post.