12 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Neck Care Therapy, Model: SYK 509B
FDA 510(k)
FDA Class 2
·Neurology
RENOVIS SURGICAL HIP JOINT REPLACEMENT PROSTHESIS
FDA 510(k)
FDA Class 2
·Orthopedic
SENSE HEAD 16 MODEL 800647, SENSE SPINE 16 MODEL 800646; SENSE TORSO 16 MODEL 800645
FDA 510(k)
FDA Class 2
·Radiology
PULSE GEN MODEL 102R
FDA Adverse Event
Injury
·CYBERONICS, INC.·Product code LYJ·June 17, 2013
VITALITY 2
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 22, 2011
BRAVO
FDA Adverse Event
Malfunction
·ARIZONA DEVICE MANUFACTURING·Product code FFT·September 19, 2008
APPROACH CTO MICROWIRE WIRE GUIDE
FDA Adverse Event
Injury
·Product code DQX·May 21, 2021
APPROACH CTO MICROWIRE WIRE GUIDE
FDA Adverse Event
Injury
·COOK INC·Product code DQX·December 28, 2021
APPROACH CTO MICROWIRE WIRE GUIDE
FDA Adverse Event
Malfunction
·COOK INC·Product code DQX·October 17, 2023
APPROACH CTO MICROWIRE WIRE GUIDE
FDA Adverse Event
Malfunction
·COOK INC·Product code DQX·October 3, 2023
APPROACH CTO MICROWIRE WIRE GUIDE
FDA Adverse Event
Injury
·COOK INC·Product code DQX·October 31, 2023
Disposable Accessory Kit, 3-Arm (Box of 5) individually sealed in poly-Tyvek pouches / Rx Sterile / to used exclusively on the Intuitive Surgical Da Vinci Si Robotic system / Distributed by Intuitive Surgical Product Usage: Microtek Medical Equipment Drapes are intended to cover/wrap various surgical and/or nonsurgical instruments/equipment [e.g. robotic arms, microscopes, tables, x ray systems, light handles, etc]. They function as a physical barrier to prevent cross contamination between the instrument / equipment and medical staff and/or to allow the instrument/equipment to enter a hygienic area [e.g. sterile surgical field] in various clinical settings. They are typically made of flexible plastic and shaped to fit the type of instrument / equipment. They are a single use device [not to be reprocessed]
FDA Enforcement
Class II
·Terminated·Ecolab Inc·October 31, 2018