14 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Luggie Super
FDA 510(k)
FDA Class 2
·Physical Medicine
FAMILY OF SELECTA OPHTHALMIC LASER SYSTEMS (SELECTA 1064, SELECTA SLT, SELECTA DUO), DELIVERY DEVICE AND ACCESSORIES
FDA 510(k)
FDA Class 2
·Ophthalmic
NB3D BONE VOID FILLER
FDA 510(k)
FDA Class 2
·Orthopedic
PASSEO-18 5/200/90
FDA Adverse Event
Malfunction
·BIOTRONIK AG, BUELACH, SWITZERLAND·Product code LIT·September 28, 2021
PASSEO-18 6/200/90
FDA Adverse Event
Malfunction
·BIOTRONIK AG, BUELACH, SWITZERLAND·Product code LIT·September 28, 2021
SEDLINE KIT
FDA Adverse Event
Malfunction
·MASIMO - 40 PARKER·Product code MWI·December 7, 2017
PASSEO-18 2.5/170/130
FDA Adverse Event
Malfunction
·BIOTRONIK AG, BUELACH, SWITZERLAND·Product code LIT·January 20, 2021
SEDLINE KIT
FDA Adverse Event
Malfunction
·MASIMO - 40 PARKER·Product code MWI·January 8, 2017
SEDLINE KIT
FDA Adverse Event
Malfunction
·MASIMO - 40 PARKER·Product code GWQ·July 21, 2017
TI MATRIX LOCKING CAP
FDA Adverse Event
Injury
·SYNHES (USA) BRANDYWINE·Product code NKB·June 7, 2013
TARGIS SYSTEM
FDA Adverse Event
Malfunction
·UROLOGIX, INC.·Product code MEQ·July 7, 2011
PYXIS ANESTHESIA SYSTEM 3500
FDA Adverse Event
Malfunction
·CARDINAL HEALTH - PYXIS PRODUCTS·Product code BRY·September 5, 2008
BD INSYTE¿ AUTOGUARD¿
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·December 20, 2018
ELEKTA LIMITED Precise Digital Accelerator, REF MRT 6001, MRT 6011; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
FDA Enforcement
Class II
·Ongoing·Elekta, Inc.·December 13, 2023