12 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VELASHAPE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
BD CONNECTA STOPCOCK
FDA Adverse Event
Malfunction
·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FMG·July 20, 2020
HYPERQ AD-100 SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
STRYKER NAVIGATION SYSTEM-KNEE MODULE
FDA 510(k)
FDA Class 2
·Neurology
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·May 21, 2013
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·September 18, 2014
CONSULTA CRT-D
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code NIK·June 14, 2011
BD CONNECTA¿ STOPCOCK
FDA Adverse Event
Malfunction
·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FMG·January 2, 2020
MALIBU
FDA Adverse Event
Injury
·SEASPINE INC.·Product code NKB·February 12, 2020
MALIBU
FDA Adverse Event
Injury
·SEASPINE INC.·Product code NKB·February 12, 2020
Achieva TX Interventional Coil 3.0T
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·December 4, 2024
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