15 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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NEURO CHECK DEVICE WITH IO-FLEX WIRE
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
BAXANO IO-FLEX SYSTEM
FDA Adverse Event
Other
·BAXANO, INC.·Product code HAE·July 2, 2012
BAXANO IO-FLEX SYSTEM
FDA Adverse Event
Other
·BAXANO, INC.·Product code HAE·July 2, 2012
BAXANO IO-FLEX SYSTEM
FDA Adverse Event
Other
·BAXANO, INC.·Product code HAE·July 2, 2012
MOTIONLOC SCREW FOR NCB POLYAXIAL LOCKING PLATING SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
BECKMAN COULTER DNASE B CALIBRATOR
FDA 510(k)
FDA Class 2
·Clinical Chemistry
TAMPAX RADIANT TAMPON UNSCENTED, ABSORBENCY UNKNOWN
FDA Adverse Event
Malfunction
·TAMBRANDS MANUFACTURING, INC·Product code HEB·March 10, 2021
TAMPAX RADIANT TAMPON UNSCENTED, ABSORBENCY UNKNOWN
FDA Adverse Event
Malfunction
·TAMBRANDS MANUFACTURING, INC·Product code HEB·March 3, 2021
BD INSYTE AUTOGUARD
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·October 14, 2024
ASR UNI FEMORAL IMPL SIZE 47
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·May 14, 2013
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·September 23, 2014
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·June 1, 2011
EMBLEM S-ICD Model A209
FDA Enforcement
Class I
·Terminated·Boston Scientific Corporation·February 17, 2021
Smiths Medical Medfusion Model 3500 Syringe pumps, Item Numbers: a) 3500 b) 3500-0600-00 c) 3500-0600-01 d) 3500-0600-249 e) 3500-0600-50 f) 3500-0600-51 g) 3500-0600-82 h) 3500-306 i) 3500-402 j) 3500-414 k) 3500-415 l) 3500-500 m) 3500E n) 3500VX-306 o) 3500VX-500
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·April 24, 2024
EMBLEM S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A209
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·February 3, 2021