12 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Zavation IBF System
FDA 510(k)
FDA Class 2
·Orthopedic
Border-Lock® Upper Tray #46R
FDA UDI
DEN-MAT HOLDINGS, LLC·00359883007119·Dental impression tray, single-use
Border-Lock® Upper Tray #46R
FDA UDI
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.·07540172015882·Dental impression tray, single-use
HAMILTON-C1
FDA Adverse Event
Malfunction
·HAMILTON MEDICAL AG·Product code CBK·August 30, 2024
SPIRALE DRUG DELIVERY SYSTEM
FDA 510(k)
FDA Class 2
·Anesthesiology
TT-102
FDA 510(k)
FDA Unclassified
·Unknown
ACCU-CHEK COMFORT CURVE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code NBW·April 3, 2006
DEVICE 0158/181246 IMPLANTED 05-FEB-2009
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWP·February 10, 2010
PROGRAMMING SOFTWARE
FDA Adverse Event
Malfunction
·CYBERONICS, INC.·Product code LYJ·July 8, 2011
BHR
FDA Adverse Event
Injury
·SMITH & NEPHEW ORTHOPAEDICS LTD·Product code NXT·June 21, 2013
FLOGARD
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·October 17, 2014
Merlin PCS Programmer software model 3330, used with Confirm Rx Insertable Cardiac Monitor (ICM), Model DM3500, Sterile. The firm name on the label of the ICM is St. Jude Medical Cardiac Rhythm Management Division, Sylmar, CA. - Product Usage: The Confirm Rx insertable cardiac monitor is designed to detect arrhythmias and wirelessly transmit data to the Merlin.net Patient Care Network. The Confirm Rx ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.
FDA Enforcement
Class II
·Terminated·St Jude Medical, Cardiac Rhythm Management Division·January 22, 2020