11 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DIAMOND-5A/6A/8A
FDA 510(k)
FDA Class 2
·Radiology
BINAX NOW COVID-19 AG CARD KIT 40T EUA
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·June 22, 2023
BINAX NOW COVID-19 AG CARD KIT 40T EUA
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·June 22, 2023
BINAX NOW COVID-19 AG CARD KIT 40T EUA
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·June 22, 2023
BINAX NOW COVID-19 AG CARD KIT 40T EUA
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·June 22, 2023
STERISPINEPS PEDICLE SCREW
FDA 510(k)
FDA Class 2
·Orthopedic
MIDAS TOUCH, NITRILE EXAMINATION GLOVES, POWDER-FREE, GREY
FDA 510(k)
FDA Class 1
·General Hospital
INFINITI VISION SYSTEM
FDA Adverse Event
Injury
·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·July 27, 2011
ADVIA 1800
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code JJE·June 27, 2013
ACCU-CHEK TENDER INFUSION SET
FDA Adverse Event
Injury
·DISETRONIC MEDICAL SYSTEMS·Product code FOZ·October 7, 2008
TrueBeam Radiotherapy Delivery System version 2.0 and 2.5 EDGE Radiotherapy Delivery System version 2.0 and 2.5 Product Usage: The TrueBeam delivery systems are intended to provide radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems·October 10, 2018