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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)
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Top companies in PGW

DateFirm and productCodeLinked 510(k)
Nov 4, 2025Integra LifeSciences Corp. (NeuroSciences)
TruDi Navigation System - Multi Instrument Adapter; - Manufacturer's Product Number (Catalog Number): EM-2025-000F Rev 00 or Rev 01;
Open, Classified
PGWK231862
Aug 5, 2024Integra LifeSciences Corp.
TruDi NAV Suction, 0 Degrees; Model/Catalog Number: TDNS000Z. TruDi" NAV Suction Instruments are intended for use with the TruDi" Navigation System during surgical procedures in ENT medicine and skul
Open, Classified
PGWK180948
May 23, 2024Stryker Leibinger GmbH & Co. KG
8000-021-002, Scopis ENT Software with TGS with Sofware Version: NOVA 3.6.0 RC16. Scopis is a next-generation solution for navigating functional endoscopic sinus surgery (FESS) offering surgeons highl
Open, Classified
PGWK221098
Oct 20, 2023Acclarent, Inc.
TruDi Navigation System, Model: FG-2000-00, Catalog: ENS022B, when used with TruDi Curette, Models: TDC0005Z and TDC0005
Open, Classified
PGWK192397
Nov 12, 2021Acclarent, Inc.
TruDi NAV Suction Instruments: 0-Degree, REF: TDNS000Z; 70-Degree, REF: TDNS070Z; and 90-Degree, REF: TDNS090Z
Open, Classified
PGWK180948
Mar 6, 2019Acclarent, Inc.
TruDi NAV Suction, TDNS090Z, 90 Degree Tip Angle, (01) 10705031245891
Terminated
PGWK180948
Mar 6, 2019Acclarent, Inc.
TruDi NAV Suction, TDNS070Z, 70 Degree Tip Angle (01) 10705031245884
Terminated
PGWK180948
Mar 6, 2019Acclarent, Inc.
TruDi NAV Suction, TDNS000Z, 0 Degree Tip Angle, (01)10705031245877
Terminated
PGWK180948
Jun 29, 2017Medtronic Navigation, Inc.
Medtronic ENT Prgm 9734636 Add Fusion Nav AxiEM, reusable, Rx. This kit includes 9733908 (which includes 9733452 containing 9733449, Straight Suction, 9733450, 70 deg Curved Suction, and 9733451, 90
Terminated
PGWK153555
Jun 29, 2017Medtronic Navigation, Inc.
Medtronic Set Supplemental INS AxiEM ENT, Ref. 9734378, reusable, RX. This kit contains 9734308, Small Straight suction. The firm name on the label is Medtronic Navigation, Inc., Louisville, CO. Th
Terminated
PGWK153555
Jun 29, 2017Medtronic Navigation, Inc.
Medtronic Instrument Kit 9733908 Fusion ENT, reusable, RX. This kit includes Kit 9733452 (containing 9733449, Straight Suction, 9733450, 70 deg Curved Suction, and 9733451, 90 deg Curved Suction). T
Terminated
PGWK153555
Jun 29, 2017Medtronic Navigation, Inc.
Medtronic Instrument Set EM ENT, Ref. #9733452 and #9733452-G02, reusable, RX. This kit contains 9733449, Straight Suction, 9733450, 70 deg Curved Suction, and 9733451, 90 deg Curved Suction. The
Terminated
PGWK153555
Jun 29, 2017Medtronic Navigation, Inc.
Medtronic Suction 9734308 Small AxiEM ENT, reusable, Rx. The firm name on the label is Medtronic Navigation, Inc., Louisville, CO. The suction devices are part of a family of reusable ENT instrument
Terminated
PGWK153555
Jun 29, 2017Medtronic Navigation, Inc.
Medtronic Curved Suction 90 9733451 EM ENT, reusable, Rx. The firm name on the label is Medtronic Navigation, Inc., Louisville, CO. The suction devices are part of a family of reusable ENT instrume
Terminated
PGWK153555
Jun 29, 2017Medtronic Navigation, Inc.
Medtronic Curved Suction 70 9733450 EM ENT, reusable, Rx. The firm name on the label is Medtronic Navigation, Inc., Louisville, CO. The suction devices are part of a family of reusable ENT instrumen
Terminated
PGWK153555
Jun 29, 2017Medtronic Navigation, Inc.
Medtronic Straight Suction 9733449 EM ENT, reusable, Rx. The firm name on the label is Medtronic Navigation, Inc., Louisville, CO. The suction devices are part of a family of reusable ENT instrument
Terminated
PGWK153555
Apr 19, 2017Stryker Instruments Div. of Stryker Corporation
Stryker PROFESS Registration Kit. The Stryker PROFESS Registration Kit is a member of the Navigation portfolio and is used as an intraoperative guidance system to enable intranasal and sinus computer-
Terminated
PGWK141551

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