18 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MRCAT
FDA 510(k)
FDA Class 2
·Radiology
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B16741514350·
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B1674151435060·
ProLift
FDA UDI
Life Spine, Inc.·00190837137991·
ProLift
FDA UDI
Life Spine, Inc.·00190837086190·
UMBILI-CATH
FDA Adverse Event
Malfunction
·UTAH MEDICAL PRODUCTS·Product code FOS·January 7, 2016
ESENSOR CYSTIC FIBROSIS CARRIER DETECTION TEST , ESENSOR 4800 DNA DETECTION SYSTEM, MODEL 4800
FDA 510(k)
FDA Class 2
·Immunology
IMIX PANORAD AND SOMARAD
FDA 510(k)
FDA Class 2
·Radiology
BD AFFIRM¿ VPIII MICROBIAL IDENTIFICATION TEST
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code MLA·December 29, 2022
AMISTEM H HA COATED STD STEM SIZE 2
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·August 9, 2019
A-C RAPID-D/LINK
FDA Adverse Event
Malfunction
·FRESENIUS KABI DEUTSCHLAND GMBH·Product code FPA·June 7, 2013
FINELINE II
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVN·July 6, 2011
ACS HI-TORQUE IRON MAN GUIDE WIRE
FDA Adverse Event
Injury
·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code DQX·September 5, 2008
Precise Digital Accelerator Delivery of radiation to defined target volumes
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·September 26, 2012
Elekta Synergy XVI. Radiation Therapy Digital Imager. Product XVI R3.5.1, R4.2.1, and R4.5.1 Used as part of radiation therapy treatment process.
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·March 20, 2013
SL & SLi Series (Mod 15/18/20/25) Linear Accelerator Used for radiation therapy treatments of malignant neoplastics diseases.
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·March 26, 2014
Precise Treatment Table. To be used as part of radiation therapy treatment process.
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·April 17, 2013
All Elekta digital accelerators with electrons and beam modulator, MLCi/MLCi2, Agility or Asymmetric Heads Product Usage: Deliver of radiation to defined target volumes
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·March 12, 2014