FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K140992 |
ARTHROCARE CORPORATION |
ARTHROCARE NASASTENT CMC NASAL DRESSING |
06/16/2014 |
K230142 |
BioMed ENT, Inc. |
Epi-Stop Nasal Gel/epistaxis pack |
03/22/2023 |
K972096 |
BOSTON MEDICAL PRODUCTS, INC. |
BIVALVE NASAL SPLINT |
07/15/1997 |
K972082 |
BOSTON MEDICAL PRODUCTS, INC. |
CUSTOM NASAL SPLINT |
07/03/1997 |
K972151 |
BOSTON MEDICAL PRODUCTS, INC. |
DOYLE COMBO NASAL AIRWAY SPLINT |
07/07/1997 |
K972092 |
BOSTON MEDICAL PRODUCTS, INC. |
NASAL AIRWAY SPLINT |
07/08/1997 |
K070496 |
CARBYLAN BIOSURGERY |
ADVACOAT SINUS GEL AND STENT |
03/15/2007 |
K063308 |
CARBYLAN BIOSURGERY |
ADVACOAT SINUS GEL, MODEL 9100, ADVA SINUS STENT, MODEL 9200 |
12/04/2006 |
K172179 |
Chitogel Ltd |
Chitogel Endoscopic Sinus Surgery Kit |
10/17/2017 |
K113585 |
COGENT THERAPEUTICS, LLC |
NASAL/EPISTAXIS PACK |
04/25/2012 |
K130354 |
ENTRIGUE SURGICAL, INC. |
MEDIENT MIDDLE TURBINATE IMPLANT; (SINGLE PACK-1 PAIR, FOUR PACK-4 PAIR) |
05/29/2013 |
K012532 |
GENZYME CORP. |
SEPRAGEL SINUS |
10/30/2001 |
K181696 |
Gyrus ACMI, Inc |
ChitoZolve |
11/30/2018 |
K122494 |
HEMOSTASIS, LLC |
POSISEP AND POSISEP X HEMOSTAT DRESSING/INTRANASAL SPLINT |
03/27/2013 |
K141704 |
MEDTRONIC INC. |
NOVASHIELD INJECTABLE NASAL PACKING AND STENT |
10/06/2014 |
K202623 |
Medtronic Xomed |
Novapak Nasal Sinus Packing and Stent |
12/08/2020 |
K041381 |
MEDTRONIC XOMED, INC. |
MEROPACK BIORESORBABLE NASAL PACKING AND SINUS STENT |
09/10/2004 |
K141816 |
Polyganics BV |
HEMOPORE |
10/23/2014 |
K052099 |
Polyganics BV |
NASOPORE NASAL DRESSING, MODEL NDOX-YYY/ZZ |
11/21/2005 |
K141423 |
Polyganics BV |
NASOPORE-FD |
08/07/2014 |
K981374 |
POREX SURGICAL, INC. |
POREX NOSTRIL RETAINERS |
07/02/1998 |
K011544 |
SEIKAGAKU CORP. |
HADGEL, 4 GRAM/SYRINGE |
08/15/2001 |
K980221 |
SILIMED, LLC. |
SILIMED NASAL RETAINER |
04/02/1998 |
K092401 |
SINEXUS, INC. |
SINEXUS SINUS STENT GEN 2, MODEL 1999-25 |
11/17/2009 |
K132721 |
SPIWAY LLC |
SPIWAY ENDONASAL ACCESS GUIDE |
01/29/2014 |
K153686 |
SPIWAY LLC |
SPIWay Endonasal Access Guide |
01/28/2016 |
K180141 |
SPIWay, LLC |
SPIWay Endonasal Access Guide |
02/16/2018 |
K213153 |
SPIWay, LLC |
SPIWay Endonasal Access Guide |
10/27/2021 |
K170913 |
STS Medical |
Composite Removable Sinus Stent System |
12/15/2017 |
K082276 |
SYNTHEMED, INC. |
SYNTHEMED DEVICE |
11/18/2008 |
K002131 |
WALTER LORENZ SURGICAL, INC. |
LACTOSORB ETHMOID STENT |
04/13/2001 |
K080247 |
Z-MEDICA CORPORATION |
QUIKCLOT NOSEBLEED |
02/27/2008 |