13 results
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25ms
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Sources: EU EUDAMED, US FDA
OPTUM(TM) AUTOMATED PATIENT ASSIST DEVICE
FDA 510(k)
FDA Class 2
·General Hospital
TLX
FDA UDI
Nuvasive, Inc.·00887517730480·TLX Implant, 8x13x40mm 10°
UniTip Catheter
FDA UDI
Unisensor AG·07640172972410·
UniTip Catheter
FDA UDI
Unisensor AG·07640172973776·
EnVisio Navigation Sytem
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CUSTOM COMFORT NIGHTGUARD
FDA 510(k)
FDA Unclassified
·Unknown
ACTIVA
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·December 21, 2012
COAGUCHEK® XS SYSTEM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code GJS·June 19, 2014
HOYER LIFT
FDA Adverse Event
Other
·APEX HEALTHCARE MFG INC·Product code FNG·September 16, 2010
OMNIPOD 5 AUTOMATED INSULIN DELIVERY SYSTEM
FDA Adverse Event
Injury
·INSULET CORPORATION·Product code QFG·September 3, 2025
Biosense Webster's Reprocessed SOUNDSTAR eco Diagnostic Ultrasound Catheters, Catalog Nos: M-5723-115, Model Number BIO10438577.
FDA Recall
Terminated
·STERILMED, INC.·Product code OWQ·September 24, 2014
Folysil Silicone Foley Catheters, Device Reference Numbers AA6106, AA6108, AA6110, AA6112, AA6114, AA6116, AA6118, AA6120, AA6122, AA6124, AA6308, AA6310, AA6312, AA6314, AA6316, AA6318, AA6320, AA6322, AA6324, AA6408, AA6410, AA6412, AA6414, AA6416, AA6418, AA6420, AA6422, AA6424, AA6C18, AA6C20, AA6C22, and AA6C24.
FDA Enforcement
Class II
·Ongoing·Coloplast Manufacturing US, LLC·January 22, 2025
Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 12, 2020