Medtronic Navigation, Inc.
Medtronic Navigation, Inc. holds FDA 510(k) medical device clearances, first cleared 2005, most recent 2026, with 91 FDA device recalls on record.
Top product codes for Medtronic Navigation, Inc.
FDA recalls by Medtronic Navigation, Inc.
10 most recent of 91- Z-1022-2025 — Medtronic PIN, 100mm STERILE PERCUTANEOUS REF: 9733235 Medtronic PIN, 150MM, STERILE PERCUTANEOUS REF: 97733236 The Sterile Percutaneous Reference Pin Set is intended to be used to place and remove a pin percutaneously into bony patient anatomy for rigid attachment of a patient reference during image-guided surgeries using a Medtronic computer-assisted surgery system.
- Z-0050-2025 — StealthStation S8 App versions 1.3.0 and 1.3.2, (Model # 9735762) The StealthStation System, with StealthStation Spine software, is intended as an aid for precisely locating anatomical structures in either open or percutaneous neurosurgical and orthopedic procedures.
- Z-1776-2024 — Stealth S8 Clinical Software Application, REF: 9735762, CE0344, Rx Only. Used in the StealthStation System as an aid for locating anatomical structures in either open or percutaneous neurosurgical procedures.
- Z-0698-2024 — Medtronic, REF 9733235, Pin, 100mm, STERILE, PERCUTANEOUS
- Z-0699-2024 — Medtronic, REF 9733236, Pin, 150mm, STERILE, PERCUTANEOUS
- Z-0188-2024 — StealthStation S8 Application version 2.0 and 2.0.1 (Part 9735762) The StealthStation System, with StealthStation Cranial software, is intended as an aid for locating anatomical structures in either open or percutaneous neurosurgical procedures. The StealthStation FlexENT System, with StealthStation ENT software, is intended as an aid for locating anatomical structures in either open or percutaneous ENT procedures.
- Z-1630-2023 — StealthStation Cranial Software, Models: 9735585, 9735586 (kit), 9735587 (kit), used with StealthStation S7/i7 systems
- Z-1666-2023 — StealthStation Cranial Software, Model: 9735585, used with StealthStation S7/i7 systems
- Z-1039-2023 — AxiEM" Non-Invasive Patient Tracker
- Z-0953-2023 — RadiaLux Lighted Retractor (Pink), REF: 50-101-1
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Medtronic Navigation, Inc.
- K253379 — Stealth AXiS Cranial clinical application
- K253395 — Stealth AXiS ENT clinical application
- K253391 — Visualase Cooled Laser Applicator System (3 models)
- K253381 — Stealth AXiS Surgical System with Stealth AXiS Spine clinical application
- K251282 — StealthStation S8 Spine Software
- K242464 — Stealth Spine Clamps; ModuLeX Shank Mounts
- K240465 — O-arm O2 Imaging System
- K231976 — StealthStation Cranial Software, v3.1.5 (9735585)
- K221087 — Synergy Cranial v2.2.9, StealthStation Cranial v3.1.4
- K211269 — Visualase MRI-Guided Laser Ablation System (SW 3.4)
- K203639 — StealthStation Cranial Software v1.3.2
- K200723 — StealthStation FlexENT (9736242), StealthStation S8 ENT Software (9735762)
- K201175 — StealthStation Cranial Software v1.3.0
- K201189 — Stealthstation S8 Spine Software v1.3.0
- K191597 — Stealth Autoguide System, Midas Rex Legend Depth Stop System
- K190672 — StealthStation Synergy Cranial S7 Software v.2.2.8, StealthStation Cranial Software v3.1.1
- K181859 — Visualase Thermal Therapy System
- K170018 — StealthStationTM S8 ENT Software
- K162655 — StealthConnect Remote Viewing, Planning and Collaboration System
- K162309 — StealthStation S8 System Platforms and StealthStation Cranial Software
- K162604 — Cranial Reducing Tubes
- K153660 — StealthStation System with Cranial Software
- K153555 — EM ENT Navigated Suctions
- K153247 — Fusion Compact Navigation System
- K150216 — Synergy Cranial
- K141833 — STYLET, 23CM, SKULL-MOUNT PATIENT TRACKER, NON-INVASIVE PATIENT TRACKER, TRACER POINTER, TOUCH-N-GO POINTER, NAVIGATION
- K133444 — STEALTHSTATION S7 / I7 / FUSION NAVIGATION SYSTEMS, AXIEM NAVIGATION SYSTEM
- K133665 — MALLEABLE SUCTION INSTRUMENTS
- K131425 — NAVIGATED CAPSTONE TRIALS, CLYDESDALE TRIALS, CAPSTONE & CLYDESDALE INSERTER
- K130608 — QUADCUT
- K124004 — NAVIGATED CD HORIZON SOLERA SCREWDRIVERS, TAPS, ILIAC TAPS, LEGACY TAPS
- K081512 — STEALTHVIZ ADVANCED PLANNING APPLICATION WITH STEALTHDTI PACKAGE
- K061248 — AXIEM IMAGELESS HIP MODULE FOR THE STEALTHSTATION SYSTEM
- K052623 — IMAGELESS HIP MODULE FOR THE STEALTHSTATION SYSTEM
- K050651 — MEDTRONIC ORTHOPAEDIC TRAUMA APPLICATION
Data sourced from openFDA. This site is unofficial and independent of the FDA.