15 results
·
22ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
PATHWAY MODEL 07XXXX
FDA 510(k)
FDA Class 2
·Orthopedic
21 G X 1.25 IN BD ECLIPSE¿ BLOOD COLLECTION NEEDLE WITH LUER ADAPTER
FDA Adverse Event
Injury
·BECTON, DICKINSON & CO., (BD)·Product code FMI·August 2, 2017
MONARCH III IOL DELIVERY SYSTEM; MONARCH III P CATRIDGE; MONARCH III HANDPIECE (H4)
FDA 510(k)
FDA Class 1
·Ophthalmic
R120 MODULAR TOTAL HIP SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
ANIMAS INSULIN CARTRIDGE
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·May 14, 2013
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·September 23, 2014
INFLATABLE PENILE PROSTHESIS
FDA Adverse Event
Injury
·AMERICAN MEDICAL SYSTEMS, INC.·Product code FAE·May 25, 2011
21 G X 1.25 IN BD ECLIPSE¿ BLOOD COLLECTION NEEDLE WITH LUER ADAPTER
FDA Adverse Event
Injury
·BECTON, DICKINSON & CO., (BD)·Product code FMI·July 29, 2017
Y-KNOT FLEX 1.3MM ALL-SUTURE ANCHOR WITH ONE NO. 2 WHITE/BLUE HI-FI SUTURE
FDA Adverse Event
Malfunction
·CONMED CORPORATION·Product code MBI·April 23, 2019
ADVIA CENTAUR XP HIV AG/AB COMBO (CHIV) ASSAY
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code MZF·March 20, 2018
ADVIA CENTAUR XP HIV AG/AB COMBO (CHIV) ASSAY
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code MZF·March 20, 2018
ADVIA CENTAUR XP HIV AG/AB COMBO (CHIV) ASSAY
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code MZF·March 20, 2018
ADVIA CENTAUR XP HIV AG/AB COMBO (CHIV) ASSAY
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code MZF·March 20, 2018
ADVIA CENTAUR XP HIV AG/AB COMBO (CHIV) ASSAY
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code MZF·March 20, 2018
INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021