FDA 510(k) Applications for Medical Device Product Code: NHB (Polymer, Ear, Nose And Throat, Synthetic, Absorbable)

FDA 510(k) Applications for Medical Device Product Code "NHB"
(Polymer, Ear, Nose And Throat, Synthetic, Absorbable)

FDA 510(k) Number	Applicant	Device Name	Decision Date
K183015	3-D Matrix, Inc.	PuraSinus	04/12/2019
K192661	Entellus Medical, Inc. (Aka Stryker ENT)	LATERA Absorbable Nasal Implant System	11/10/2019
K092590	ETHICON, INC.	PDS PLATES	02/17/2010
K210411	Hemostasis LLC	PosiSep EAR Fragmentable Ear Dressing	05/05/2022
K012769	MACROPORE BIOSURGERY, INC.	MACROPORE ENT RECONSTRUCTION FILM	10/25/2001
K070886	MEDTRONIC INC.	MEROGEL INJECTABLE BIORESORBABLE STENT	04/26/2007
K122434	MEDTRONIC XOMED	MEROGEL INJECTABLE BIORESORBABLE NASAL DRESSING AND SINUS STENT AND OTOLOGIC GEL	10/31/2012
K070715	Polyganics BV	NASOPORE EAR	05/07/2007
K233569	Spirair, Inc.	SeptAlign	03/22/2024
K223167	Spirair, Inc.	Spirair Nasal Septal Strap	08/17/2023
K152958	SPIROX, INC.	INEX Absorbable Nasal Implant	12/04/2015
K161191	SPIROX, INC.	Latera Absorbable Nasal Implant	06/23/2016
K132920	SPIROX, INC.	SPIROX INEX DEVICE	06/10/2014
K012409	WALTER LORENZ SURGICAL, INC.	LORENZ LACTOSORB LARYNGOTRACHEAL RECONSTRUCTION IMPLANTS	10/18/2001