14 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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TERASON USMART3200 AND BENQ UP200ULTRASOUND SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613017774·K-Wire, Double Ended, Trocar Point, Diameter Si...
PORTA SOLDER 1090 W
FDA 510(k)
FDA Class 2
·Dental
POLYTEL(R) APT MODEL: PWA-08-01
FDA 510(k)
FDA Class 2
·Cardiovascular
SYRINGE 1.0ML 29GA 1/2IN BLS 500 AU
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMF·March 25, 2020
BD VENFLON¿ PRO SAFETY PERIPHERAL SAFETY IV CATHETER
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FOZ·February 7, 2022
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·November 16, 2018
FEMORAL COMPONENT
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code JDH·May 31, 2013
PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·June 27, 2011
ACCU-CHEK COMFORT CURVE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·August 28, 2008
SYRINGE 1.0ML 29GA 1/2IN BLS 500 AU
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMF·March 23, 2020
CORAIL2 STD SIZE 12
FDA Adverse Event
Malfunction
·DEPUY IRELAND - 9616671·Product code LZO·May 30, 2024
TrueBeam Radiotherapy Delivery System and EDGE" Radiotherapy Delivery System, K140528. The TrueBeam and Edge Systems are intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation therapy is indicated for adults and pediatric patients.
FDA Recall
Terminated
·Vision RT Ltd Dove House, Arcadia Avenue London United Kingdom·Product code IYE·June 30, 2016
TrueBeam¿ Radiotherapy Delivery System and EDGE" Radiotherapy Delivery System, K140528. The TrueBeam and Edge Systems are intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation therapy is indicated for adults and pediatric patients.
FDA Enforcement
Class II
·Terminated·Vision RT Ltd·August 31, 2016