11 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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LightMed Dental Laser System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Polysorb
FDA UDI
Covidien LP·20884521126807·Absorbable Single Stitch Reload
STAINLESS STEEL FEMORAL NAILING SYSTEM
FDA UDI
ORTHOFIX SRL·18032568033564·INTERNAL TEMPLATE D 10 MM FEMORAL NAIL
INFX-8000V WITH
FDA 510(k)
FDA Class 2
·Radiology
ALIGN URETHRAL SUPPORT SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PEN NDL 32G 4MM PRO 100 BOX 1200 US
FDA Adverse Event
Malfunction
·EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND·Product code FMI·May 22, 2025
PEN NDL 32G 4MM PRO 100 BOX 1200 US
FDA Adverse Event
Malfunction
·EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND·Product code FMI·May 27, 2025
LTV
FDA Adverse Event
Injury
·CAREFUSION 203, INC.·Product code CBK·June 5, 2013
CURRENT RF VR
FDA Adverse Event
Injury
·ST. JUDE MEDICAL INC., CRMD·Product code LWS·January 13, 2014
ACCU-CHEK SPIRIT
FDA Adverse Event
Injury
·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code LZG·July 13, 2011
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