12 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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CAPIOX SX18 HOLLOW FIBER OXYGENATOR WITH DETACHABLE HARDSHELL RESERVOIR, CAPIOX SX25 HOLLOW FIBER OXGENATOR WITH DETACHA
FDA 510(k)
FDA Class 2
·Cardiovascular
ArgenZ HT+ 98x18 ML C1B
FDA UDI
ARGEN CORPORATION, THE·D818130359·Dental porcelain/ceramic restoration kit
EVONOS
FDA UDI
Gyrus ACMI, LLC·00821925013766·RONIS SMOOTH CURRETTE
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450294871·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172973530·
KD-726 MEMORY WRIST AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
DARCO HEADED CANNULATED SCREW
FDA 510(k)
FDA Class 2
·Orthopedic
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 28, 2025
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·May 24, 2013
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·September 30, 2014
INRATIO2
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code GJS·May 9, 2011
The Merlin PCS 3650 programmer Model 3330 The Merlin PCS programmer model 3650 is a portable, dedicated programming system which operates using the Merlin PCS Model 3330 software and is designed to interrogate, program, display data from, and test Abbott Medical implantable devices and leads.
FDA Enforcement
Class II
·Ongoing·Abbott Medical·January 1, 2025