7 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PROCLEAR (OMAFILCON A) DAILY DISPOSABLE/DAILY WEAR SOFT CONTACT LENS
FDA 510(k)
FDA Class 2
·Ophthalmic
HOFFMAN II HYBRID RING CLAMP
FDA 510(k)
FDA Class 2
·Orthopedic
CVPROFILOR D0-2020 CARDIOVASCULAR PROFILING SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
5MM CANNULA ACCESSORY
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL,INC.·Product code NAY·April 16, 2013
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·September 4, 2014
ITREL 3
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·April 6, 2011
CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD, Inc.·June 24, 2015