12 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Nester Embolization Coils, Tornado Embolization Coils
FDA 510(k)
FDA Class 2
·Cardiovascular
UNKNOWN
FDA Adverse Event
Injury
·COOK INC·Product code KRD·November 6, 2020
UNKNOWN
FDA Adverse Event
Injury
·COOK INC·Product code KRD·November 6, 2020
UNKNOWN
FDA Adverse Event
Injury
·COOK INC·Product code KRD·November 6, 2020
NESTER PLATINUM EMBOLIZATION COIL
FDA Adverse Event
Injury
·COOK INC·Product code KRD·June 14, 2020
NESTER PLATINUM EMBOLIZATION COIL
FDA Adverse Event
Injury
·COOK INC·Product code KRD·February 19, 2020
LEFORTE NEURO SYSTEM BONE PLATE
FDA 510(k)
FDA Class 2
·Dental
EXCELSIOR XT-27 MICROCATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 8, 2014
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MPRI·Product code DTB·June 8, 2013
COLLEAGUE PRE 1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 8, 2011
ELEKTA LIMITED Versa HD, REF XRT 2121, 2131; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
FDA Enforcement
Class II
·Ongoing·Elekta, Inc.·December 13, 2023