ClearanceBrief
Panels › Ear, Nose, Throat › Product code NHB · Class 2

Polymer, Ear, Nose And Throat, Synthetic, Absorbable

Regulation 874.3620

2510(k)s in 12 months (16 all time)
0recalls in 12 months (15 all time)
14recalls that name a 510(k)
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Top companies in NHB

Company510(k)sRecalls
Stryker Corporation014
Spirair, Inc.40
Spirox, Inc.30
3-D Matrix, Inc.11
Entellus Medical, Inc. (Aka Stryker Ent)10
ETHICON, Inc.10
Hemostasis, LLC10
Macropore Biosurgery, Inc.10
Medtronic, Inc.10
Medtronic Xomed10
Decided510(k)Device and applicantCode
Jul 30, 2026K260620SeptAlign (SPLN001)
Spirair, Inc.
NHB
Jan 16, 2026K251790SeptAlign
Spirair, Inc.
NHB
Mar 22, 2024K233569SeptAlign
Spirair, Inc.
NHB
Aug 17, 2023K223167Spirair Nasal Septal Strap
Spirair, Inc.
NHB
May 5, 2022K210411PosiSep EAR Fragmentable Ear Dressing
Hemostasis, LLC
NHB
Nov 10, 2019K192661LATERA Absorbable Nasal Implant System
Entellus Medical, Inc. (Aka Stryker Ent)
NHB
Apr 12, 2019K183015PuraSinus
3-D Matrix, Inc.
NHB
Jun 23, 2016K161191Latera Absorbable Nasal Implant
Spirox, Inc.
NHB
Dec 4, 2015K152958INEX Absorbable Nasal Implant
Spirox, Inc.
NHB
Jun 10, 2014K132920SPIROX INEX DEVICE
Spirox, Inc.
NHB
Oct 31, 2012K122434MEROGEL INJECTABLE BIORESORBABLE NASAL DRESSING AND SINUS STENT AND OTOLOGIC GEL
Medtronic Xomed
NHB
Feb 17, 2010K092590PDS PLATES
ETHICON, Inc.
NHB
May 7, 2007K070715NASOPORE EAR
Polyganics B.V.,, NL
NHB
Apr 26, 2007K070886MEROGEL INJECTABLE BIORESORBABLE STENT
Medtronic, Inc.
NHB
Oct 25, 2001K012769MACROPORE ENT RECONSTRUCTION FILM
Macropore Biosurgery, Inc.
NHB
Oct 18, 2001K012409LORENZ LACTOSORB LARYNGOTRACHEAL RECONSTRUCTION IMPLANTS
Walter Lorenz Surgical, Inc.
NHB

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