11 results
·
26ms
·
Sources: EU EUDAMED, US FDA
FELTLOC CAST PADDING
FDA 510(k)
FDA Class 1
·Physical Medicine
KENTEX
FDA UDI
KENTRON HEALTHCARE, INC.·00852244007471·FULLY AUTOMATIC ARM BLOOD PRESSURE MONITOR
Hereaeus Poseidon Microcatheter
FDA 510(k)
FDA Class 2
·Cardiovascular
CLEARPATH
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·May 5, 2014
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·October 15, 2012
COATED VICRYL PLUS (POLYGLACTIN 910) SUTURE
FDA Adverse Event
Malfunction
·ETHICON, INC.·Product code GAM·August 2, 2010
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
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
PROPONENT DR SL (Model L201)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025