11 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
UNIPOR BREATHING CIRCUIT FILTER
FDA 510(k)
FDA Class 2
·Anesthesiology
PALL ULTIPOR 25 BREATHING SYSTEM FILTER
FDA Adverse Event
Injury
·PALL NEWQUAY·Product code CAH·July 13, 2018
PALL ULTIPOR 100 BREATHING SYSTEM FILTER
FDA Adverse Event
Injury
·PALL NEWQUAY·Product code CAH·April 18, 2017
KENTEX
FDA UDI
KENTRON HEALTHCARE, INC.·00852244007495·DELUXE FULLY AUTOMATIC ARM BLOOD PRESSURE MONITOR
Palm Bladder Scanner - PBSV5.1
FDA 510(k)
FDA Class 2
·Radiology
AUTO SYRINGE MODEL AS-3A
FDA 510(k)
FDA Class 2
·General Hospital
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·May 5, 2014
VIRTUOSO II DR
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL, INC.·Product code LWS·October 15, 2012
MARQUIS SERIES STOPCOCKS
FDA Adverse Event
Malfunction
·MERIT MEDICAL SYSTEMS, INC.·Product code DTL·August 6, 2010
PROPONENT DR SL (Model L201)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025
TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·May 20, 2015