10 results
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19ms
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Sources: EU EUDAMED, US FDA
SHARPSCAN
FDA 510(k)
FDA Class 2
·General Hospital
CASCADIA™ Interbody System
FDA UDI
VB Spine LLC·10888857554610·Trial Size 14x18x12 mm, Convex
MODIFICATION TO ALKP
FDA 510(k)
FDA Class 2
·Clinical Chemistry
IVAS 2-10MM (10 GUAGE) BALLON CATHETER
FDA 510(k)
FDA Class 2
·Orthopedic
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code PAH·May 22, 2013
ATTAIN OTW
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·June 14, 2011
BIPOL LEAD MODEL 300
FDA Adverse Event
Malfunction
·CYBERONICS, INC.·Product code LYJ·August 15, 2008
Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000
FDA Enforcement
Class I
·Ongoing·Covidien·November 8, 2023
Marathon Flow Directed Micro Catheter, UltraFlow HPC Flow Directed Micro Catheter Marathon Flow: The device is intended to access periphera and neurovasculature for the controlled selective infusion of physician-specified therapeutics agents such as embolization materials and of diagnostic materials such as contrast media. UltraFlow HPC Flow: The device is intended for the controlled selective infusion of physician-specified pharmacologic agents or contrast media into the distal vasculature of the peripheral and neuroanatomy. It is not intended for use in the coronary vasculature. Catalog No. 105-5055V02 105-5055V02 105-5055V05 105-5065V02 105-5065V05 105-5066V02 105-5066V05
FDA Enforcement
Class I
·Terminated·Micro Therapeutics Inc, Dba Ev3 Neurovascular·November 16, 2016
The Merlin PCS 3650 programmer Model 3330 The Merlin PCS programmer model 3650 is a portable, dedicated programming system which operates using the Merlin PCS Model 3330 software and is designed to interrogate, program, display data from, and test Abbott Medical implantable devices and leads.
FDA Enforcement
Class II
·Ongoing·Abbott Medical·January 1, 2025