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Medtronic Xomed, Inc.

FDA Regulatory Profile

Summary

Total Recalls
26 (5 Class I)
510(k) Clearances
46
Inspections
7
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2461-2025Class IIIPC Powerease System REF 2300000 UDI-DI: 00613994448705 00643169406834. The IPC POWEREASE SystJuly 17, 2025
Z-1623-2025Class IINIM Vital Nerve Monitoring System: CONSOLE NIM4CM01 NIM 4.0, REF: NIM4CM01; CONSOLE NIM4CM01RF NMarch 10, 2025
Z-3130-2024Class IIMedtronic ENT Ultra Round Steel Cutting Bur, Model Number REF 31313069July 5, 2024
Z-2409-2024Class INIM Vital Nerve Monitoring systems (all serial numbers manufactured) with NIM Vital System versions:June 24, 2024
Z-0696-2024Class IINIM TriVantage EMG Endotracheal Tubes, Model (REF) Numbers and sizes: a) 8229706, 6.0MM ID; b) 82November 7, 2023
Z-1224-2022Class IINIM Vital Patient Interface 4.0 (P/N: NIM4CPB1) NIM with Software version 1.3.2May 3, 2022
Z-1223-2022Class IINIM Vital Console 4.0 (P/N: NIM4CM01) NIM with Software version 1.3.2May 3, 2022
Z-1521-2022Class INIM EMG Endotracheal Tube, Part Numbers: a) REF 8229307J b) REF 8229308J c) REF 8229306JApril 29, 2022
Z-1520-2022Class INIM EMG Endotracheal Tube, Part Numbers: a) REF 8229308 b) REF 8229307 c) REF 8229306April 29, 2022
Z-1519-2022Class INIM CONTACT EMG Endotracheal Tube, Part Numbers: a) REF 8229508 b) REF 8229507 c) REF 8229506April 29, 2022
Z-0743-2022Class IINIM TRIVANTAGE EMG Endotracheal TubeDecember 22, 2021
Z-0961-2022Class IISoftware 1898072 IPC upgrade v 2.7.3.0, IPC System: a) CONSOLE 1898001 IPC, Product Number 1898001;December 15, 2021
Z-0156-2022Class IIMedtronic sterile single-use blades that are components of the StraightShot M Series Handpiece and FAugust 31, 2021
Z-0158-2022Class IIMedtronic Sterile single-use blades that are components of the StraightShot M Series Handpiece and FAugust 31, 2021
Z-0157-2022Class IIMedtronic sterile single-use blades that are components of the StraightShot M Series Handpiece and FAugust 31, 2021
Z-2673-2020Class IISoftware 1898072 IPC upgrade v 2.7.3.0 - Product Usage: The IPC system is indicated for the incisionJune 12, 2020
Z-0734-2020Class IILamicel 20PK 5MM INTLNovember 13, 2019
Z-0735-2020Class IILamicel 10PK 10MM INTLNovember 13, 2019
Z-0733-2020Class IILamicel 20PK 3MM INTL Cervical dilatorNovember 13, 2019
Z-0901-2017Class IINIM EMG Endotracheal Tube, 6.0 mm I.D. x 8.8 mm O.D. (27 FR), Reinforced, Sterile, Rx only. IndividJune 28, 2016

Recent 510(k) Clearances

K-NumberDeviceDate
K251672NIM Essence™ EMG Endotracheal Tube (NIMEID060); NIM Essence™ EMG Endotracheal Tube (NIMEID065); NIM February 10, 2026
K230320NIM Standard Reinforced EMG Endotracheal Tube; CONTACT Reinforced EMG Endotracheal TubeOctober 26, 2023
K231580NIM™ 35cm long Surgeon Control Probe, 1mm Ball-Tip (NIMDTP35)August 30, 2023
K213246NIM Surgeon Control Probe, Prass Tip, NIM Surgeon Control Probe, 1mm Ball Tip, NIM Surgeon Control PMarch 21, 2022
K210841NuVent Eustachian Tube Dilation BalloonAugust 16, 2021
K202623Novapak Nasal Sinus Packing and StentDecember 8, 2020
K200759NIM Vital, Nerve Integrity MonitorOctober 28, 2020
K173855Sharpsite AC Rigid EndsocopeApril 20, 2018
K152121NuVent EM Sinus Dilation SystemDecember 1, 2015
K151758ALAR Nasal Valve StentOctober 29, 2015
K150728XPS Nexus System, XPS Nexus Foot Control, XPS Nexus IV PoleAugust 14, 2015
K151067Ventilation (Tympanostomy) TubesJuly 22, 2015
K132297EM SINUS DILATION SYSTEMNovember 5, 2013
K122391MEDTRONIC XOMED, INC.January 10, 2013
K122434MEROGEL INJECTABLE BIORESORBABLE NASAL DRESSING AND SINUS STENT AND OTOLOGIC GELOctober 31, 2012
K112686NEXT GEN EMG ENDOTRACHEAL TUBEJune 27, 2012
K110623PILLAR PALATAL IMPLANT SYSTEMFebruary 10, 2012
K112662MICROFRANCE(R) WORMALD VASCULAR CLAMPJanuary 20, 2012
K111520IPC POWEREASE SYSTEMOctober 26, 2011
K083124NIM 3.0February 27, 2009