ClearanceBrief
Panels › Neurology › Product code PGW · Class 2

Ear, Nose, And Throat Stereotaxic Instrument

Regulation 882.4560

3510(k)s in 12 months (38 all time)
1recalls in 12 months (17 all time)
17recalls that name a 510(k)
Get daily alerts for PGWSample briefCSV

Top companies in PGW

Company510(k)sRecalls
Medtronic Navigation, Inc.68
Acclarent, Inc.85
Fiagon GmbH110
Biosense Webster20
Scopis GmbH20
Stryker Corporation20
Stryker Ent20
Brainlab AG10
Claronav10
Integra LifeSciences Corp.01
Decided510(k)Device and applicantCode
Sep 4, 2026K262235ApexCut ™ Blade with Automated EM Tracking (187BL4012EM);ApexCut ™ Blade with Automated EM Tracking (187BL4040EM);ApexCu
Medtronic Xomed, Inc.
PGW
Jun 2, 2026K261540Cube 4D Navigation System, VirtuEye Pro
Fiagon GmbH, DE
PGW
Mar 16, 2026K253395Stealth AXiS™ ENT clinical application
Medtronic Navigation, Inc.
PGW
Jun 20, 2025K243053Navient Image Guided Navigation System (ENT) (955-NC-NC)
Claronav, CA
PGW
Jul 21, 2023K231862TruDi® Navigation System V3 (FG-2000-00)
Acclarent, Inc.
PGW
Apr 27, 2023K223734ENT EM
Brainlab AG, DE
PGW
Jul 20, 2022K221037TruDi Shaver Blade
Acclarent, Inc.
PGW
Jul 12, 2022K221098Scopis ENT Software, Scopis ENT Software with TGS, Scopis Planning Software, Electromagnetic Navigation Unit
Stryker Corporation, DE
PGW
Jul 19, 2021K211291Cube Navigation System, VirtuEye V2, Navigation Sensor NanoRest, Navigation Unit Cube 4D
Fiagon GmbH, DE
PGW
Oct 9, 2020K202609Instrument Clamps Electromagnetic
Stryker Corporation, DE
PGW
Aug 12, 2020K201174TruDi Curette
Acclarent, Inc.
PGW
Jun 26, 2020K200723StealthStation FlexENT (9736242), StealthStation S8 ENT Software (9735762)
Medtronic Navigation, Inc.
PGW
Mar 23, 2020K193453TruDi Probe
Acclarent, Inc.
PGW
Mar 10, 2020K200041FlexPointer 1.5 Single Use, FlexTube 3 Single Use
Fiagon GmbH, DE
PGW
Feb 21, 2020K193118TGS Guidewire and updated Scopis Software
Stryker Ent
PGW
Feb 14, 2020K193502TGS Universal Headrest with Mounting Arm
Stryker Ent
PGW
Jan 30, 2020K192397TruDi Navigation System
Biosense Webster
PGW
May 3, 2019K190532TruDi NAV Wire
Acclarent, Inc.
PGW
Jul 20, 2018K180948TruDi NAV Suction Instruments
Acclarent, Inc.
PGW
Mar 10, 2018K173628Acclarent ENT Navigation System
Acclarent, Inc.
PGW
Sep 27, 2017K171661Scopis Extended Instrument Set EM
Scopis GmbH, DE
PGW
May 19, 2017K170018StealthStationTM S8 ENT Software
Medtronic Navigation, Inc.
PGW
Feb 16, 2017K163416Fiagon Navigation – PointerTube Straight and PointerTube Keat
Fiagon GmbH, DE
PGW
Feb 9, 2017K161491Scopis Hybrid Navigation System EM
Scopis GmbH, DE
PGW
Dec 1, 2016K162176Fiagon Navigation System
Fiagon GmbH, DE
PGW
Oct 24, 2016K161701CARTO ENT System
Biosense Webster
PGW
Oct 24, 2016K161697Acclarent NavWire Sinus Navigation Guidewire
Acclarent, Inc.
PGW
Oct 21, 2016K161555KARL STORZ NAV1 Electromagnetic Navigation System
Karl Storz Endoscopy America, Inc.
PGW
Sep 18, 2016K161940Guidewire 0.6 Single Use
Fiagon GmbH, DE
PGW
Apr 7, 2016K153555EM ENT Navigated Suctions
Medtronic Navigation, Inc.
PGW
Mar 23, 2016K160479PointerShell Universal, PointerShell LS
Fiagon GmbH, DE
PGW
Mar 10, 2016K160369GuideWire
Fiagon GmbH, DE
PGW
Feb 18, 2016K153247Fusion Compact Navigation System
Medtronic Navigation, Inc.
PGW
Apr 16, 2015K150473FlexPointer 1.5 mm
Fiagon GmbH, DE
PGW
Oct 8, 2014K141456THE FIAGON NAVIGATION - EXTENDED INSTRUMENT SET ENT, REGISTRATIONPOINTER, VENTERAPOINTER, GUIDEWIRE, POINTERSHELL
Fiagon GmbH, DE
PGW
Sep 8, 2014K141551PROFESS SOFTWARE, PROFESS CURVED 70 (DEGREES) SUCTION, PROFESS CURVED 70 (DEGREES) SUCTION, PROFESS CURVED 90 (DEGREES)
Stryker Corporate
PGW
Apr 30, 2014K133573FIAGON NAVIGATION SYSTEM
Fiagon GmbH, DE
PGW
Mar 13, 2014K133665MALLEABLE SUCTION INSTRUMENTS
Medtronic Navigation, Inc.
PGW

Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.