FDA 510(k) Applications for Medical Device Product Code "NHB"
|
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 |
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 |