59 results
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29ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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IN-CERAM SPINELL KIT FOR CELAV MODEL V56-001/E63013
FDA 510(k)
FDA Class 2
·Dental
Eye Shield
FDA UDI
KATENA PRODUCTS, INC.·00841668111161·FOX EYE SHIELD GARTERS WHITE PACK OF 50
PicoSure Workstation
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
VITROS IMMUNODIAGNOSTIC PRODUCTS CORTISOL REAGENT PACK AND CALIBRATORS AND METABOLISM CONTROLS
FDA 510(k)
FDA Class 2
·Clinical Chemistry
SYNCHRON URIC ACID
FDA Adverse Event
BECKMAN COULTER INC.·Product code KNK·June 10, 2011
ALARIS 17 INCH EXT SET W/.2MF & VLV PORT
FDA Adverse Event
Malfunction
·CAREFUSION·Product code FPA·February 11, 2020
ALARIS 17 INCH EXT SET W/.2MF & VLV PORT
FDA Adverse Event
Malfunction
·CAREFUSION·Product code FPA·February 18, 2020
PUMP IN STYLE ADVANCED BREAST PUMP GO TOTE
FDA Adverse Event
Malfunction
·MEDELA INC.·Product code HGX·June 24, 2014
MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM
FDA Adverse Event
Injury
·MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH·Product code MCM·February 11, 2013
PRECISION XTRA
FDA Adverse Event
Malfunction
·Product code NBW·January 13, 2011
XP-XP Tibial Tray - Interlok 87 mm Item # 195760
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·September 18, 2019
ALARIS SMARTSITE EXTENSION SET
FDA Adverse Event
Malfunction
·CAREFUSION·Product code FPA·December 28, 2019
SMARTSITE EXTENSION SET
FDA Adverse Event
Malfunction
·CAREFUSION·Product code FPA·March 5, 2020
BD ALARIS SMARTSITE LOW SORBING SET
FDA Adverse Event
Malfunction
·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·April 19, 2022
BD SMARTSITE¿ NEEDLE-FREE CONNECTOR
FDA Adverse Event
Malfunction
·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·July 29, 2022
BD SMARTSITE¿ NEEDLE-FREE CONNECTOR
FDA Adverse Event
Malfunction
·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·November 14, 2022
SMALLBORE 6 INCH EXT VLV
FDA Adverse Event
Malfunction
·Product code FPA·June 9, 2021
SMALLBORE 6 INCH EXT VLV
FDA Adverse Event
Malfunction
·Product code FPA·May 10, 2021
BD SMARTSITE¿ NEEDLE-FREE CONNECTOR
FDA Adverse Event
Malfunction
·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·January 13, 2023
LL VLV ADPT(STAND ALONE)
FDA Adverse Event
Malfunction
·CFN MEXICO 215 SA DE CV·Product code FPA·August 24, 2020