15 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CONCORDE BULLET SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
INCLUDER CLAMP
FDA 510(k)
FDA Class 2
·Cardiovascular
COLORED POWDER FREE AND POLYMER COATED EXAMINATION GLOVE (BLUE, BLACK AND PINK) WITH A PROTEIN CLAIM OF LESS THAN
FDA 510(k)
FDA Class 1
·General Hospital
BD INSYTE AUTOGUARD
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·November 5, 2024
BAXANO IO-FLEX SYSTEM
FDA Adverse Event
Other
·BAXANO, INC.·Product code HAE·July 2, 2012
HARMONIC SCALPEL CURVED SHEAR (EXACT CODE UNKNOWN)
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY, LLC.·Product code GEI·December 23, 2019
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
VERTEBRAL AUGMENTATION ACCESS KIT
FDA Adverse Event
Malfunction
·SYNTHES USA·Product code NDN·May 14, 2013
530G INSULIN PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OZO·September 23, 2014
ACTIVE® INHIBIN A ELISA, 4X96 WELLS
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code NDR·June 1, 2011
BD INSYTE AUTOGUARD
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·November 5, 2024
BD INSYTE AUTOGUARD
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·November 6, 2024
Video Duodenoscope
FDA Enforcement
Class II
·Terminated·Pentax Medical Company·June 8, 2016
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