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Sources: EU EUDAMED, US FDA
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Surgical microscope The device is used to improve the visibility of objects through magnification and illumination and can be applied for observation and documentation and for human veterinary medical treatment.
FDA Enforcement
Class II
·Terminated·Leica Microsystems (Schweiz) Ag·September 18, 2013
AXS Infinity LS Long Sheath:((6F/.088in)/ x 70cm GEN-10800-70, (6F/.088in)/ x 80cm GEN-10800-80, (6F/.088in)/ x 90cm GEN-10800-90) Made in Ireland, Sterile EO. The AXS Infinity LS Long Sheath system contents are: One (1) AXS Infinity LS Long Sheath, One (1) Hemostasis valve with extension tubing, One Long Dilator.
FDA Enforcement
Class II
·Terminated·Stryker Neurovascular·October 10, 2018
Surgical microscope The device is used to improve the visibility of objects through magnification and illumination and can be applied for observation and documentation and for human veterinary medical treatment.
FDA Enforcement
Class II
·Terminated·Leica Microsystems (Schweiz) Ag·September 18, 2013
Coaxial Micro-Introducer Kit. Greatbatch Part Number/Bard Access Systems Order Number/Part Description 10636-001 8004011 Kit Coax 10 Pack 4FR Bard 10636-002 8005011 Kit Coax 10 Pack 5FR Bard 10636-007 8004012 Kit Coax 10 Pack 4FR Bard 10636-008 8005012 Kit Coax 10 Pack 5FR Bard 10636-009 8004022 Kit Coax 10 Pack 5FR Bard 10636-010 8005022 Kit Coax 10 Pack 5FR Bard The Coaxial Micro-Introducer set contains a 21 gauge disposable introducer needle, 0.018 inch floppy tip guidewire, and a radiopaque Coaxial Micro Introducer consisting of a sheath and dilator. The Coaxial Micro-Introducer Set is used to introduce up to a 0.038 inch guidewire or catheter into the vascular system following a small 21 gauge needle stick.
FDA Enforcement
Class II
·Terminated·Greatbatch Medical·May 21, 2014
Ventstar Coax, MP03373
FDA Enforcement
Class I
·Terminated·Draeger Medical, Inc.·May 24, 2023
Ventstar Coax 180, MP03374
FDA Enforcement
Class I
·Terminated·Draeger Medical, Inc.·May 24, 2023
Ventstar Coax 230, MP03376
FDA Enforcement
Class I
·Terminated·Draeger Medical, Inc.·May 24, 2023
ID Coax 180, MP03375
FDA Enforcement
Class I
·Terminated·Draeger Medical, Inc.·May 24, 2023
Anesthesia Set Coax 180, MP03384
FDA Enforcement
Class I
·Terminated·Draeger Medical, Inc.·May 24, 2023
VentStar Coax (P) 150, MP00379
FDA Enforcement
Class I
·Terminated·Draeger Medical, Inc.·May 24, 2023
Anesthesia Circuit Kit Coax HEPA, MP17102
FDA Enforcement
Class I
·Terminated·Draeger Medical, Inc.·May 24, 2023
Anesthesia Circuit Kit Coax 3, MP02732
FDA Enforcement
Class I
·Terminated·Draeger Medical, Inc.·May 24, 2023
Anesthesia Circuit Kit Coax 1, MP02730
FDA Enforcement
Class I
·Terminated·Draeger Medical, Inc.·May 24, 2023
Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DC use in conjunction with the SmartDrive MX2+ Wheelchair Power Assist component.
FDA Enforcement
Class I
·Ongoing·Max Mobility LLC·September 24, 2025
Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DCK use in conjunction with the SmartDrive MX2+ Wheelchair Power Assist component.
FDA Enforcement
Class I
·Ongoing·Max Mobility LLC·September 24, 2025
Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DCMC use in conjunction with the SmartDrive MX2+ Wheelchair Power Assist component.
FDA Enforcement
Class I
·Ongoing·Max Mobility LLC·September 24, 2025
The product is a handheld ultraviolet-C germicidal wand and contains two, narrow-diameter, tubular lamps with a peak emission wavelength in the 254 nm range with an intended use of disinfecting surfaces.
FDA Enforcement
Class II
·Ongoing·MAX LUX CORP·December 8, 2021
Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DCK use in conjunction with the SmartDrive MX2+ Wheelchair Power Assist component.
FDA Enforcement
Class I
·Ongoing·Max Mobility LLC·February 19, 2025
Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DC use in conjunction with the SmartDrive MX2+ Wheelchair Power Assist component.
FDA Enforcement
Class I
·Ongoing·Max Mobility LLC·February 19, 2025
Artix MT Thrombectomy Device, REF: 32-102
FDA Enforcement
Class II
·Ongoing·Inari Medical - Oak Canyon·May 14, 2025