Data / Medical devices / United States / Medtronic Xomed, Inc.
Medtronic Xomed, Inc.: FDA-registered device maker in Jacksonville, FL, United States, 116 510(k) clearances
Medtronic Xomed, Inc. is registered with the FDA (registration 1045254) in Jacksonville, FL, United States. It lists 82 device types. The FDA files 116 510(k) clearances under its listings, the newest dated September 4, 2026. 25 recall events name it as the recalling firm (3 Class I). Registered through 2027. FDA data exported November 3, 2026.
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- FDA registration number
- 1045254
- Address
- 6743 Southpoint DR. North, Jacksonville, FL, United States, 32216
- Owner or operator
- Medtronic, Inc. (2112641)
- Roles
- Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- July 20, 1992
- Registered through
- 2027
- Brand names listed
- , MOTORS, ALAR Nasal Valve Stent, AUSTIN ENDOLYMPH DISPERSMENT SHUNT, AccuGuide Injection Monitor, Airvance, Alinity i HAVAb IgG Controls (LN 08P2710), Anti-snoring device, ApexCut EM Navigated Blades and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance. Newest 100 of 116.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 4, 2026 | K262235 | ApexCut Blade with Automated EM Tracking (187BL4012EM);ApexCut Blade with Automated EM Tracking (187BL4040EM);ApexCut Blade with Automated EM Tracking (187BL4060EM);ApexCut Blade with Automated EM Tracking (187BL2975EM);ApexCut Blade with Automated EM Tracking (187BL3590EM);ApexCut Blade with Automated EM Tracking (187BL4000LEM) | PGW | Substantially Equivalent | Medtronic Xomed, Inc. | accessdata.fda.gov |
| March 13, 2026 | K253391 | Visualase Cooled Laser Applicator System (9735559); Visualase Cooled Laser Applicator System (9735560); Visualase Cooled Laser Applicator System (9735561) | ONO | Substantially Equivalent | Medtronic Navigation, Inc. | accessdata.fda.gov |
| February 10, 2026 | K251672 | NIM Essence EMG Endotracheal Tube (NIMEID060); NIM Essence EMG Endotracheal Tube (NIMEID065); NIM Essence EMG Endotracheal Tube (NIMEID070); NIM Essence EMG Endotracheal Tube (NIMEID075); NIM Essence EMG Endotracheal Tube (NIMEID080) | ETN | Substantially Equivalent | Medtronic Xomed, Inc. | accessdata.fda.gov |
| October 26, 2023 | K230320 | NIM Standard Reinforced EMG Endotracheal Tube; CONTACT Reinforced EMG Endotracheal Tube | ETN | Substantially Equivalent | Medtronic Xomed, Inc. | accessdata.fda.gov |
| August 30, 2023 | K231580 | NIM 35cm long Surgeon Control Probe, 1mm Ball-Tip (NIMDTP35) | ETN | Substantially Equivalent | Medtronic Xomed, Inc. | accessdata.fda.gov |
| March 21, 2022 | K213246 | NIM Surgeon Control Probe, Prass Tip, NIM Surgeon Control Probe, 1mm Ball Tip, NIM Surgeon Control Probe, 1mm Ball Tip, 35cm Long | ETN | Substantially Equivalent | Medtronic Xomed, Inc. | accessdata.fda.gov |
| January 7, 2022 | K211269 | Visualase MRI-Guided Laser Ablation System (SW 3.4) | ONO | Substantially Equivalent | Medtronic Navigation, Inc. | accessdata.fda.gov |
| August 16, 2021 | K210841 | NuVent Eustachian Tube Dilation Balloon | PNZ | Substantially Equivalent | Medtronic Xomed, Inc. | accessdata.fda.gov |
| December 8, 2020 | K202623 | Novapak Nasal Sinus Packing and Stent | LYA | Substantially Equivalent | Medtronic Xomed | accessdata.fda.gov |
| October 28, 2020 | K200759 | NIM Vital, Nerve Integrity Monitor | GWF | Substantially Equivalent | Medtronic Xomed, Inc. | accessdata.fda.gov |
| May 12, 2019 | K183515 | MR8 Drill System, Midas Rex MR8 ClearView Tools | HBC | Substantially Equivalent | Medtronic Powered Surgical Solutions | accessdata.fda.gov |
| March 6, 2019 | K181859 | Visualase Thermal Therapy System | LLZ | Substantially Equivalent | Medtronic Navigation, Inc. | accessdata.fda.gov |
| January 11, 2019 | K182928 | CD Horizon Spinal System | NQP | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| November 2, 2018 | DEN170056 | Parathyroid Detection (Model PTeye) System | QDF | Unknown | Aibiomed, Corp. | accessdata.fda.gov |
| April 20, 2018 | K173855 | Sharpsite AC Rigid Endsocope | EOB | Substantially Equivalent | Medtronic Xomed, Inc. | accessdata.fda.gov |
| March 8, 2018 | K173249 | CD HORIZON Spinal System | NKB | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| May 15, 2017 | K170312 | IPC systems, Legend EHS handpieces and Legend Stylus Touch handpiece, Microsaw handpieces,Triton electric high torque handpiece, Attachments and surgical dissecting tools | HBC | Substantially Equivalent | Medtronic Powered Surgical Solutions | accessdata.fda.gov |
| December 1, 2015 | K152121 | NuVent EM Sinus Dilation System | LRC | Substantially Equivalent | Medtronic Xomed, Inc. | accessdata.fda.gov |
| October 29, 2015 | K151758 | ALAR Nasal Valve Stent | GAT | Substantially Equivalent | Medtronic Xomed, Inc. | accessdata.fda.gov |
| August 14, 2015 | K150728 | XPS Nexus System, XPS Nexus Foot Control, XPS Nexus IV Pole | ERL | Substantially Equivalent | Medtronic Xomed, Inc. | accessdata.fda.gov |
| July 22, 2015 | K151067 | Ventilation (Tympanostomy) Tubes | ETD | Substantially Equivalent | Medtronic Xomed, Inc. | accessdata.fda.gov |
| November 5, 2013 | K132297 | EM SINUS DILATION SYSTEM | LRC | Substantially Equivalent | Medtronic Xomed, Inc. | accessdata.fda.gov |
| August 7, 2013 | K130608 | QUADCUT | HAW | Substantially Equivalent | Medtronic Navigation, Inc. | accessdata.fda.gov |
| January 10, 2013 | K122391 | MEDTRONIC XOMED, INC. | LRK | Substantially Equivalent | Medtronic Xomed, Inc. | accessdata.fda.gov |
| August 27, 2012 | K121264 | TRITON ELECTRIC HIGH TORQUE HANDPIECE AND SOFTWARE MODULE | HBE | Substantially Equivalent | Medtronic Surgical Technologies | accessdata.fda.gov |
| June 27, 2012 | K112686 | NEXT GEN EMG ENDOTRACHEAL TUBE | ETN | Substantially Equivalent | Medtronic Xomed, Inc. | accessdata.fda.gov |
| October 26, 2011 | K111520 | IPC POWEREASE SYSTEM | HBE | Substantially Equivalent | Medtronic Xomed, Inc. | accessdata.fda.gov |
| May 18, 2010 | K100193 | OTOMAG BONE CONDUCTION HEARING SYSTEM | LXB | Substantially Equivalent | Sophono, Inc. | accessdata.fda.gov |
| July 20, 2009 | K090838 | STIMULUS/DISSECTION INSTRUMENTS | ETN | Substantially Equivalent | Axon Systems, Inc. | accessdata.fda.gov |
| February 27, 2009 | K083124 | NIM 3.0 | GWF | Substantially Equivalent | Medtronic Xomed, Inc. | accessdata.fda.gov |
| October 17, 2008 | K081475 | ELECTRIC DRILL SYSTEM [XPS 4000 SYSTEM, MIDAS REX LEGEND EHS SYSTEM, INTEGRATED POWER CONSOLE (IPC)] | HBE | Substantially Equivalent | Medtronic Xomed, Inc. | accessdata.fda.gov |
| September 5, 2008 | K081277 | XPS 4000 SYSTEM, MIDAS REX LEGEND EHS SYSTEM, INTEGRATED POWER CONS0LE (IPC) | ERL | Substantially Equivalent | Medtronic Xomed, Inc. | accessdata.fda.gov |
| September 18, 2007 | K072315 | MIDAS REX CURVED BUR | HBE | Substantially Equivalent | Medtronic Powered Surgical Solutions | accessdata.fda.gov |
| August 29, 2007 | K072088 | FLEXIBLE TRANS-NASAL VIDEO ESOPHAGOSCOPE WITH DIGITAL VIDEO PROCESSOR AND DISPOSABLE ENDOSHEATH SYSTEMS | EOX | Substantially Equivalent | Vision-Sciences, Inc. | accessdata.fda.gov |
| August 2, 2007 | K071903 | ENDOSHEATH SYSTEMS FOR USE WITH VISION-SCIENCES TNE SCOPE | EOX | Substantially Equivalent | Vision-Sciences, Inc. | accessdata.fda.gov |
| January 12, 2007 | K062996 | DISPOSABLE MONOPOLAR AND BIPOLAR STIMULATOR PROBES | GXZ | Substantially Equivalent | Axon Systems, Inc. | accessdata.fda.gov |
| December 19, 2006 | K062198 | SUNSPOTS PRE-GELLED SURFACE ELECTRODES | GXY | Substantially Equivalent | Axon Systems, Inc. | accessdata.fda.gov |
| November 29, 2006 | K063305 | STIMULATING BUR GUARD | ETN | Substantially Equivalent | Medtronic Xomed, Inc. | accessdata.fda.gov |
| November 1, 2006 | K061639 | ECLIPSE TCD NEUROVASCULAR WORKSTATION; ELCLIPSE NEUROLOGICAL WORKSTATION WITH TCD AND VASCULAR DOPPLER; CARDIOMON | GWF | Substantially Equivalent | Axon Systems, Inc. | accessdata.fda.gov |
| September 25, 2006 | K062606 | CD HORIZON SPINAL SYSTEM | MNI | Substantially Equivalent | Medtronic Sofamor Danek | accessdata.fda.gov |
| May 23, 2006 | K061113 | ORTHOMON | GWF | Substantially Equivalent | Axon Systems, Inc. | accessdata.fda.gov |
| March 1, 2006 | K053087 | VISUALASE COOLED LASER APPLICATOR SYSTEM, LASER DIFFUSING FIBER, COOLING CATHETER SYSTEM | GEX | Substantially Equivalent | Biotex, Inc. | accessdata.fda.gov |
| August 15, 2005 | K050798 | ECLIPSE NEUROLOGICAL WORKSTATION | GWF | Substantially Equivalent | Axon Systems, Inc. | accessdata.fda.gov |
| April 26, 2005 | K050194 | AXON SYSTEMS SUBDERMAL NEEDLE ELECTRODES | GXZ | Substantially Equivalent | Axon Systems, Inc. | accessdata.fda.gov |
| March 3, 2005 | K050162 | CONTACT EMG ROTATABLE ENDOTRACHEAL TUBE | ETN | Substantially Equivalent | Medtronic Xomed, Inc. | accessdata.fda.gov |
| February 23, 2005 | K043602 | QUADRANT RETRACTOR SYSTEM | GAD | Substantially Equivalent | Medtronic Sofamor Danek | accessdata.fda.gov |
| September 10, 2004 | K041381 | MEROPACK BIORESORBABLE NASAL PACKING AND SINUS STENT | LYA | Substantially Equivalent | Medtronic Xomed, Inc. | accessdata.fda.gov |
| August 12, 2004 | K041985 | XPS CURVED BUR | EQJ | Substantially Equivalent | Medtronic Xomed, Inc. | accessdata.fda.gov |
| July 23, 2004 | K041523 | XPS 3000 SYSTEM | ERL | Substantially Equivalent | Medtronic Xomed, Inc. | accessdata.fda.gov |
| July 12, 2004 | K041413 | XPS 3000 SYSTEM | ERL | Substantially Equivalent | Medtronic Xomed, Inc. | accessdata.fda.gov |
| August 5, 2003 | K031786 | TNE-2000 ESOPHAGOSCOPE WITH ECS-D ENDOSHEATH SYSTEM | EOX | Substantially Equivalent | Vision-Sciences, Inc. | accessdata.fda.gov |
| July 2, 2003 | K031790 | SLIDE-ON ENDOSHEATH SYSTEM FOR SENSORY TESTING | EOB | Substantially Equivalent | Vision-Sciences, Inc. | accessdata.fda.gov |
| June 18, 2003 | K031510 | NIM-SPINE | ETN | Substantially Equivalent | Medtronic Xomed | accessdata.fda.gov |
| April 11, 2003 | K031003 | STIMULUS/DISSECTION INSTRUMENTS, BALL-TIP PROBES | ETN | Substantially Equivalent | Medtronic Xomed, Inc. | accessdata.fda.gov |
| January 9, 2003 | K024095 | MODIFICATION TO VISION SCIENCES ENDOSHEATH SYSTEM | EOB | Substantially Equivalent | Vision-Sciences, Inc. | accessdata.fda.gov |
| January 6, 2003 | K024316 | NIM-PRS | IKN | Substantially Equivalent | Medtronic Xomed, Inc. | accessdata.fda.gov |
| July 15, 2002 | K012543 | VISION SCIENCES ENDOSHEATH SYSTEM | EOB | Substantially Equivalent | Vision-Sciences, Inc. | accessdata.fda.gov |
| January 22, 2002 | K014165 | STIMULUS - DISSECTION INSTRUMENTS | ETN | Substantially Equivalent | Medtronic Xomed, Inc. | accessdata.fda.gov |
| August 15, 2001 | K002992 | DISPOSABLE HYPODERMIC NEEDLE ELECTRODE, MODEL 9013S0421,9013S0431,9013S0441,9013S0451,9013S0461,1013S0421,103S0431 | IKT | Substantially Equivalent | Medtronic Functional Diagnostics A/S | accessdata.fda.gov |
| June 26, 2001 | K011321 | MODIFICATION TO XPS 3000 SYSTEM | ERL | Substantially Equivalent | Medtronic Xomed, Inc. | accessdata.fda.gov |
| December 4, 2000 | K002224 | XPS 3000 SYSTEM | ERL | Substantially Equivalent | Medtronic Xomed | accessdata.fda.gov |
| October 11, 2000 | K002897 | TITANIUM MIDDLE EAR PROSTHESES | ETB | Substantially Equivalent | Xomed, Inc. | accessdata.fda.gov |
| February 8, 2000 | K994262 | FRONTAL SINUS TREPHINATION CANNULA | KAM | Substantially Equivalent | Xomed, Inc. | accessdata.fda.gov |
| January 21, 2000 | K992855 | XPS STRAIGHTSHOT OR MODEL 2000 MICRODEBRIDER SYSTEM OR XPS POWERSCULPT | QPB | Substantially Equivalent | Xomed, Inc. | accessdata.fda.gov |
| November 10, 1999 | K993021 | METRX SYSTEM | HRX | Substantially Equivalent | Surgical Navigation Technologies, Inc. | accessdata.fda.gov |
| October 22, 1999 | K990793 | ACCUGUIDE MUSCLE INJECTION MONITOR | GXZ | Substantially Equivalent | Medtronic Xomed | accessdata.fda.gov |
| October 7, 1999 | K992869 | XOMED BALL-TIP MONOPOLAR STIMULATOR PROBE | ETN | Substantially Equivalent | Xomed, Inc. | accessdata.fda.gov |
| August 27, 1999 | K981677 | REPOSE BONE SCREW SYSTEM | LRK | Substantially Equivalent | Influence, Inc. | accessdata.fda.gov |
| July 13, 1999 | K991560 | NASO-LARYNGO-PHARYNGOSCOPE | EOB | Substantially Equivalent | Fiber Imaging Technologies, Inc. | accessdata.fda.gov |
| November 6, 1998 | K983025 | XOMED FEATHERTOUCH XPS POWER RASP ATTACHMENT | HRX | Substantially Equivalent | Xomed, Inc. | accessdata.fda.gov |
| October 21, 1998 | K983224 | XPS DRILL SYSTEM | ERL | Substantially Equivalent | Xomed, Inc. | accessdata.fda.gov |
| September 4, 1998 | K982595 | NIM4 | ETN | Substantially Equivalent | Xomed, Inc. | accessdata.fda.gov |
| August 27, 1998 | K982594 | ENDO-SCRUB/ENDO-SCRUB 2 | EOB | Substantially Equivalent | Xomed, Inc. | accessdata.fda.gov |
| January 30, 1998 | K973499 | XPS STRAIGHTSHOT MICROBRIDER SYSTEM OR TREBAY SHAVER SYSTEM | HRX | Substantially Equivalent | Xomed, Inc. | accessdata.fda.gov |
| January 21, 1998 | K974187 | STEALTHSTATION SYSTEM | HAW | Substantially Equivalent | Surgical Navigation Technologies, Inc. | accessdata.fda.gov |
| May 2, 1997 | K970910 | XOMED SILICONE BLOCK/STRIP | KHJ | Substantially Equivalent | Xomed, Inc. | accessdata.fda.gov |
| January 24, 1997 | K964484 | KARTUSH TM PATCHER | KHJ | Substantially Equivalent | Xomed, Inc. | accessdata.fda.gov |
| September 23, 1996 | K963246 | TREBAY MICRODEBRIDER OR XPS STRAIGHT SHOT | ERL | Substantially Equivalent | Medtronic Xomed | accessdata.fda.gov |
| July 1, 1996 | K961873 | ACTIVENT ANTIMICROBIAL VENTILATION TUBES | ETD | Substantially Equivalent | Xomed, Inc. | accessdata.fda.gov |
| April 3, 1996 | K960853 | ACE SYSTEM | EQJ | Substantially Equivalent | Xomed, Inc. | accessdata.fda.gov |
| March 24, 1995 | K940028 | ENDOSCOPE SHEATH | EOB | Substantially Equivalent | Xomed-Treace, Inc. | accessdata.fda.gov |
| March 14, 1995 | K941407 | TYMPANOSTOMY (VENTILATION) TUBE | ETD | Substantially Equivalent | Xomed-Treace, Inc. | accessdata.fda.gov |
| May 13, 1994 | K934426 | NERVE INTEGRITY MONITOR-2 (NIM-2 XL) | ETN | Substantially Equivalent | Xomed-Treace, Inc. | accessdata.fda.gov |
| August 17, 1993 | K925640 | XOMED-TREACE EMG ENDOTRACHEAL TUBEEN | ETN | Substantially Equivalent | Xomed-Treace, Inc. | accessdata.fda.gov |
| April 15, 1993 | K922880 | XOMED TREACE JET VENTILATION TUBE | BTR | Substantially Equivalent | Xomed-Treace, Inc. | accessdata.fda.gov |
| August 28, 1992 | K923027 | NEURAY SURGICAL PATTIES AND STRIPS | HBA | Substantially Equivalent | Martland Healthcare, Inc. | accessdata.fda.gov |
| June 21, 1991 | K904239 | SOFT HYDROXYLAPATITE OSSICULAR MALLEABLE PROSTHES | ETA | Substantially Equivalent | Microbio-Medics, Inc. | accessdata.fda.gov |
| April 19, 1991 | K905035 | AXOSTIM NERVE STIMULATOR, MODIFICATION | ETN | Substantially Equivalent | Singer Medical Products, Inc. | accessdata.fda.gov |
| October 31, 1990 | K902683 | SCOPESCRUBBER(TM) | EOB | Substantially Equivalent | Healthtek Microsurgical, Inc. | accessdata.fda.gov |
| June 22, 1989 | K893491 | MODEL M2-150/I-150/M2-150T/M3-150/M2-150,300-300 | FST | Substantially Equivalent | Cuda Products Co. | accessdata.fda.gov |
| April 19, 1989 | K885201 | OSSICULAR PROSTHESES 4 PARTIAL, 4 TOTAL, 2 CONVERT | ETA | Substantially Equivalent | Microbio-Medics, Inc. | accessdata.fda.gov |
| January 13, 1989 | K883727 | BUCKET PROSTHESIS PORP | ETB | Substantially Equivalent | Treace Medical, Inc. | accessdata.fda.gov |
| November 20, 1987 | K873964 | NICOLET DISPOSABLE PRASS PROBE | ETN | Substantially Equivalent | Nicolet Biomedical Instruments | accessdata.fda.gov |
| July 2, 1987 | K872112 | XOMED PLATINUM WIRE TEFLON PISTION | ETB | Substantially Equivalent | Xomed, Inc. | accessdata.fda.gov |
| January 30, 1987 | K864408 | EMG-1, MOTOR NERVE MONITOR | IKN | Substantially Equivalent | Algotek, Inc. | accessdata.fda.gov |
| January 6, 1986 | K852387 | GOODE T-TUBE WHITE SILICONE TYMPANOSTOMY TUBE | ETD | Substantially Equivalent | Xomed, Inc. | accessdata.fda.gov |
| April 11, 1985 | K850108 | EMG SURFACE, DIGITAL RING, BAR, GROUNDING, EEG | GXY | Substantially Equivalent | Nicolet Biomedical Instruments | accessdata.fda.gov |
| April 11, 1985 | K850107 | CONCENTRIC NEEDLE ELECTRODES-VARIOUS SIZES W/CONNE | GXZ | Substantially Equivalent | Nicolet Biomedical Instruments | accessdata.fda.gov |
| March 18, 1985 | K844377 | SILICONE | Substantially Equivalent | Treace Medical, Inc. | accessdata.fda.gov | |
| October 4, 1984 | K843490 | TUBE-STAT | BSR | Substantially Equivalent | Concept, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| July 17, 2025 | 97266 | Class II | Ongoing | IPC Powerease System REF 2300000 UDI-DI: 00613994448705 00643169406834. The IPC POWEREASE System is indicated for drilling, tapping, and driving screws and working end attachments during spinal surgery, including open an | Due to out of the box wobble of the driver. | accessdata.fda.gov |
| March 10, 2025 | 96511 | Class II | Ongoing | NIM Vital Nerve Monitoring System: CONSOLE NIM4CM01 NIM 4.0, REF: NIM4CM01; CONSOLE NIM4CM01RF NIM 4.0 REFURBISHED, REF: NIM4CM01RF; PATIENT INTERFACE NIM4CPB1 NIM 4.0, REF: NIM4CPB1; PATIENT INTFC NIM4CPB1RF NIM 4.0 REF | Nerve Monitoring System with certain software versions has potential for increased stimulus artifact, which may require troubleshooting, and may lead to procedure delay, extubation, and medical intervention. | accessdata.fda.gov |
| July 5, 2024 | 95162 | Class II | Ongoing | Medtronic ENT Ultra Round Steel Cutting Bur, Model Number REF 31313069 | Product was distributed past expiration date. | accessdata.fda.gov |
| June 24, 2024 | 94876 | Class I | Ongoing | NIM Vital Nerve Monitoring systems (all serial numbers manufactured) with NIM Vital System versions: v1.0.0, v1.1.1, v1.3.2, v1.4.3. NIM Vital Nerve Integrity Monitor with below product descriptions. 1. CONSOLE NIM4CM01 | Potential for false negative response on the NIM Vital Nerve Monitoring System | accessdata.fda.gov |
| November 7, 2023 | 93600 | Class II | Ongoing | NIM TriVantage EMG Endotracheal Tubes, Model (REF) Numbers and sizes: a) 8229706, 6.0MM ID; b) 8229707, 7.0MM ID; c) 8229708, 8.0MM ID; d) 8229736, 6MM ID 3PK; e) 8229737, 7MM ID 3 PK; f) 8229738, 8MM ID 3 PK | Firm received reports of customers experiencing noise from the NIM System, lead-off or high impedance issues, or loss of/intermittent nerve monitoring | accessdata.fda.gov |
| May 3, 2022 | 90163 | Class II | Ongoing | NIM Vital Console 4.0 (P/N: NIM4CM01) NIM with Software version 1.3.2 | Software anomaly was identified. | accessdata.fda.gov |
| April 29, 2022 | 90711 | Class I | Ongoing | NIM CONTACT EMG Endotracheal Tube, Part Numbers: a) REF 8229508 b) REF 8229507 c) REF 8229506 | The firm received reports of events related to airway obstruction while using NIM Standard Reinforced EMG Endotracheal Tubes & NIM CONTACT Reinforced EMG Endotracheal Tubes. | accessdata.fda.gov |
| December 22, 2021 | 89280 | Class II | Ongoing | NIM TRIVANTAGE EMG Endotracheal Tube | There is potential for multiple issues due to a manufacturing nonconformity. | accessdata.fda.gov |
| December 15, 2021 | 89847 | Class II | Terminated | Software 1898072 IPC upgrade v 2.7.3.0, IPC System: a) CONSOLE 1898001 IPC, Product Number 1898001; b) CONSOLE IPC REFURB, Product Number EC300RF; c) MASTER CONSOLE EC300 LEGEND EHS, Product Number EC300 | As a result of Medtronic's integrated power console (authentication number: 222ACBZX00018000) being used with software version: v2.7.3.0, it was discovered that there was a defect that resulted in a difference between the set number of rotations and the actual number of rotations in a specific mode when the product was used with our company's M5 handpiece. | accessdata.fda.gov |
| August 31, 2021 | 88586 | Class II | Ongoing | Medtronic sterile single-use blades that are components of the StraightShot M Series Handpiece and Fusion ENT Navigation Software, and the Midas Rex Microsaw and Triton System with the following product numbers: (1) REF | There was an increase in complaints related to tip breaks and wobble/vibration. | accessdata.fda.gov |
| June 12, 2020 | 85886 | Class II | Terminated | Software 1898072 IPC upgrade v 2.7.3.0 - Product Usage: The IPC system is indicated for the incision/cutting removal, drilling and sawing of soft and hard tissue and bone in surgical procedures. | During internal testing execution of the next generation of Integrated Power Console (IPC) prototype it was noted that the M5 Microdebrider was rotating at a higher speed than the set value in the cosole. | accessdata.fda.gov |
| November 13, 2019 | 84332 | Class II | Ongoing | Lamicel 20PK 3MM INTL Cervical dilator | Routine sterilization dose does not meet the required Sterility Assurance Level. | accessdata.fda.gov |
| June 28, 2016 | 74834 | Class II | Terminated | NIM EMG Endotracheal Tube, 6.0 mm I.D. x 8.8 mm O.D. (27 FR), Reinforced, Sterile, Rx only. Individually packaged. | Wire in tubing can become exposed, posing potential harm to the intubated patient. | accessdata.fda.gov |
| August 23, 2013 | 66355 | Class II | Terminated | Universal Titanium Prosthesis, Round Head, with Flex H/A titanium shoe. The ear prosthesis is implantable and indicated for hearing loss. | One lot of the product was assembled using the Cam Head version of the same prosthesis instead of the Round head Shaft. | accessdata.fda.gov |
| July 9, 2013 | 65837 | Class II | Terminated | Tray Surgical, ENT (various instrument trays) Used for stot age and transportation of reusable surgical instruments utilized in various ear, nose and throat (ENT) and head and neck surgical procedures. | The firm will recall and replace the identified instrument trays in the field, with trays that have improved labeling, including lids that contain the statement indicating 'PREVACUUM ONLY" | accessdata.fda.gov |
| March 4, 2013 | 64631 | Class I | Terminated | REF 8229705 x1 NIM TriVantage EMG Endotracheal Tube 5.0 mm I.D. x 6.5 mm O.D. Medtronic Xomed, Inc., 6743 Southpoint Drive North, Jacksonville, FL 32216-0980 USA STERILE Rx Only The electrodes are designed to make contac | In March 2013, Medtronic issued a recall of the NIM TriVantage EMG Endotracheal Tube due to cuff leakage in the intraoperative cuff deflation which then requires re-inflation or replacement of the deflated tube in order to ensure the continued ventilation of the patient. | accessdata.fda.gov |
| February 21, 2011 | 58075 | Not yet classified | Terminated | An external nasal splint is a rigid or partially rigid device intended for the use externally for immobilization of part of the nose. An external nasal splint is a rigid or partially rigid device intended for the use ext | Medtronic Xomed, Inc. Jacksonville, FL issued a recall on Feb 21, 2011 for all lots of the alcohol pad packaged with the Medtronic's External Nasal Splints REF 1528116 (sm), 1528126 (med), 1528136 (lg) and the Thermasplints REF 1529100 (sm), 1529110 (med), and 1529120 (lg) distributed from Jan 2008 through Aug 2010. The alcohol supplier, Cardinal Health, iss | accessdata.fda.gov |
| September 27, 2010 | 63008 | Class II | Terminated | Interfaces subject to recall: Medtronic NIM (Nerve Integrity Monitor) 3.0 Patient Interfaces 8253200 (Response) LABELING: Box Label: REF 8253200 x1***NIM-Response 3.0 Patient Interface***Medtronic Xomed, Inc., 6743 South | In January 2010, Medtronic issued a recall of Medtronic NIM 3.0 Patient Interfaces after Medtronic identified a trend of open channel conditions (signal loss from the electrode). When the NIM 3.0 detects the signal loss from the electrode (i.e. open channel), it fails the electrode check and provides an audible and visual warning to the user which could also | accessdata.fda.gov |
| July 27, 2009 | 52837 | Not yet classified | Terminated | Repose G2 Bone Screw System, Sterile, REF 76353200; Lot # 62450300. Distributed by Medtronic Xomed, Inc. Jacksonville, Florida 32216 U.S.A. The Repose G@ Bone Screw System is composed of the Repose Bone Screw (a miniatur | Medtronic Xomed, Inc. is recalling the Repose Bone Screw System product and Bone Screw product due to improper labeling. The labeling for the Repose System was inadvertently placed on the Repose Screw and vice versa. | accessdata.fda.gov |
| July 17, 2009 | 53603 | Not yet classified | Terminated | Medtronic Integrated Power Console System, IP X1 REF 1898001 or REF EC300 Medtronic Xomed, Inc., 6743 Southpoint Drive North, Jacksonville, FL 32216-0980 USA. Distributed by: Medtronic Powered Surgical Solutions, 4620 No | An error code (Code 13) is displayed on some of the consoles when a Medtronic Stylus or EHS handpiece is connected to the IPC indicating that the handpiece has not been recognized by the console. | accessdata.fda.gov |
| November 21, 2008 | 50736 | Not yet classified | Terminated | VARI-STIM III Nerve Locator/Stimulator, Sterile, Medtronic Xomed, Inc. The Vari-Stim III nerve locator/stimulator is a sterile, single-use disposable, hand-held, battery-operated device intended to stimulate motor nerves | Device may fail to operate or operate intermittently during use and such operation could result in a lack of nerve stimulation when nerve tissue is actually contacted by the stimulator. | accessdata.fda.gov |
| January 22, 2007 | 37298 | Not yet classified | Terminated | AccuGuide Injection Needles (Surface electrodes) The AccuGuide EMG Injection Needle, product 8263210, contains 5 individually packaged and sterilized injection needles and 10 nonsterile surface electrodes that are packag | A labeling discrepancy was internally identified for the surface electrode component of REF 8263210 AccuGuide EMG Injection Needle, 30G X 25MM. The outside box label correctly indicates 'Content: 5 sterile Injection Needles and 10 non-sterile Surface electrodes'; however, the pouches for the 10 surface electrodes inside the box are incorrectly labeled as 'st | accessdata.fda.gov |
| October 29, 2004 | 30357 | Not yet classified | Terminated | Brand name: NIM EMG Endotracheal Tube REF 82-29106, 82-29107, 82-29108 NIM EMG Reinforced Endotracheal Tube REF 82-29306, 82-29307, 82-29308 [All products are packaged one unit per box.] | The firm received six reports of tubes with wires 'out of channel' two of which involved injuried patients. In one case in Germany it was reported that the patient had soreness of the throat and was discharged after four days. In the next case the patient had a tracheal wound. It was not clear what caused the wound. | accessdata.fda.gov |
| January 29, 2004 | 28980 | Not yet classified | Terminated | Product is a surgical nasal/sinus surgical device labeled as a RAD Frontal Finesse Bur, Reference Number 18-83070 | The curve in the shaft of the bur was only 15 degrees not the labeled 40 degrees. | accessdata.fda.gov |
| January 25, 2002 | 25706 | Not yet classified | Terminated | Product is labeled as ''Oto-''Flex Bur'', Medtronic-Xomed brand, packed into a sterile pouch. Product is further packaged into a shelf box with similar labeling as follows: Part Number 31-55631 Oto-Flex carbide 1.0mm Bur | Product packaging pouches may be open thereby compomising the sterile barrier. | accessdata.fda.gov |
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Updated September 4, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.