Stylet, Surgical, General & Plastic Surgery
General, Plastic Surgery · 21 CFR 878.4800
Recent MDR events
37 adverse event reports on file
- VISUALASEJul 28, 2026MalfunctionMedtronic Neuromodulation2182207-2026-02067
- VISUALASEJul 10, 2026MalfunctionMedtronic Navigation, Inc.1723170-2026-00986
- VISUALASEMay 7, 2026MalfunctionMedtronic Navigation, Inc.1723170-2026-00718
- VISUALASEOct 30, 2025MalfunctionMedtronic Navigation, Inc.1723170-2025-03598
- VISUALASEAug 25, 2025MalfunctionMedtronic Navigation, Inc.1723170-2025-03057
- VISUALASEAug 19, 2025MalfunctionMedtronic Navigation, Inc.1723170-2025-03000
- VISUALASEJul 21, 2025MalfunctionMedtronic Navigation, Inc.1723170-2025-02746
- VISUALASEJul 1, 2025MalfunctionMedtronic Navigation, Inc1723170-2025-02565
- VISUALASEJun 19, 2025MalfunctionMedtronic Navigation, Inc.1723170-2025-02390
- VISUALASEMay 23, 2025MalfunctionMedtronic Navigation, Inc1723170-2025-02073
Event type breakdown
Recalls
3 recall events for this product code
- Medtronic Navigation, Inc.TerminatedOct 28, 2016
Visualase Visualization Stylets PN 020-2301. The individual components within the Visualase Body Accessory Kit are packaged in Tyvek pouches. The packaged devi
Medtronic Navigation, Inc. announces a voluntary field action for the Visualase Visualization Stylets and Visualase Body Accessory Kit because when the Visualization Stylet is placed in the magnetic field of a magnetic resonance imaging system it pulls and/or bends toward the field.
Z-0322-2017 · View FDA record ↗ - Medtronic Navigation, Inc.TerminatedOct 28, 2016
Visualase Body Accessory Kit PN 020-3000. The individual components within the Visualase Body Accessory Kit are packaged in Tyvek pouches. The packaged devices
Medtronic Navigation, Inc. announces a voluntary field action for the Visualase Visualization Stylets and Visualase Body Accessory Kit because when the Visualization Stylet is placed in the magnetic field of a magnetic resonance imaging system it pulls and/or bends toward the field.
Z-0323-2017 · View FDA record ↗ - CLINICAL LASERTHERMIA SYSTEMS ABTerminatedUnknown
Tranberg MR Cannula, REF: 4013-05, Rx Only, Sterile EO - Product Usage: used with the Tranberg MR Introducer; a device used to aid the insertion of the Laser Ap
single use devices labeled as sterile may not have been adequately sterilized
Z-1780-2021 · View FDA record ↗
Registered firms
97 firms currently registered for this product code
Spineguard, Sa
Vincennes Paris, FR
Diamond Orthopedic
Gastonia, NC, US
Med Saver, Inc.
PHOENIXVILLE, PA, US
Wexler Surgical, Inc.
HOUSTON, TX, US
Perfect Ophthalmic Instruments Fze
Dubai Dubayy, AE
3d Instrumentation Sdn Bhd
Bukit Mertajam Pulau Pinang, MY
Garish Apparels
Wazirabad Punjab, PK
Integra Microfrance Sas
SAINT AUBIN LE MONIAL Auvergne-Rhone-Alpes, FR
Millennium Surgical Corp
Schaumburg, IL, US
Aesculap Ag
TUTTLINGEN, DONAU Baden-Wurttemberg, DE
Rumex Baltics Sia
Riga, LV
Synthes Gmbh
Zuchwil Solothurn, CH
Jarit Gmbh
Rietheim-Weilheim Baden-Wurttemberg, DE
Steris Corporation
Saint Louis, MO, US
Green Or Llc
Lakeville, MN, US
Medartis Inc.
Warsaw, IN, US
Orthofix Us Llc
Lewisville, TX, US
Hgr Instrumente Gmbh
TUTTLINGEN Baden-Wurttemberg, DE
Waldemar Link Gmbh & Co. Kg
Norderstedt Schleswig-Holstein, DE
Merit Medical Canada Ltd.
Markham Ontario, CA
Coba Biomedical Pty (ltd)
Bloemfontein Free State, ZA
Maitland Engineering
South Bend, IN, US
Integra Lifesciences Corporation
Princeton, NJ, US
Novo Surgical, Inc.
Westmont, IL, US
Merit Medical Uk Limited
Earley Reading, GB
510(k) clearances
7 clearances for this product code
- Venx, LLCApr 22, 2011
K110355 · VENX REVOLUTION
- Advanced Medical Products, Inc.May 17, 2000
K000932 · ARACHNOPHLEBECTOMY NEEDLE
- Barry Markman, M.D.Nov 20, 1997
K970306 · MARKMAN TEMPLATE SYSTEM
- Apex Medical Products, LLCOct 27, 1997
K972918 · RAPID FIRE HAIR IMPLANTER CAROUSEL
- Sil-Med Corp.Oct 1, 1997
K972521 · NAVIGATOR (STYLET) 2006
- Medicamat S.A.Oct 3, 1995
K952737 · CALVITRON HAIR TRANSPLANT SYSTEM
- Padgett Instruments, Inc.Oct 27, 1977
K770970 · HAIR TRANSPLANT PUNCH, MULTIPLH