19 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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GERDX-System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668114216·LASIK CANNULA FLATTENED 23GA
BE-MOBILE 3-WHEELED ELECTRIC SCOOTER, MODEL DK S200
FDA 510(k)
FDA Class 2
·Physical Medicine
VARIAN MULTILEAF COLLIMATOR
FDA 510(k)
FDA Class 2
·Radiology
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code OZO·December 11, 2019
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code OZO·July 21, 2021
PLATE,FIXATION,BONE
FDA Adverse Event
Injury
·SYNTHES USA·Product code HRS·May 26, 2017
PLATE,FIXATION,BONE
FDA Adverse Event
Injury
·SYNTHES USA·Product code HRS·May 26, 2017
PLATE,FIXATION,BONE
FDA Adverse Event
Injury
·SYNTHES USA·Product code HRS·May 26, 2017
ENDURANT STENT GRAFT
FDA Adverse Event
Malfunction
·MEDTRONIC IRELAND·Product code MIH·August 10, 2020
ENDURANT STENT GRAFT
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code MIH·August 10, 2020
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·May 25, 2021
INGEVITY MRI
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code NVN·December 14, 2022
INTERSTIM II
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code EZW·November 6, 2014
JOSTENT ENDOSCOPIC STENT
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code FGE·September 2, 2011
STARCLOSE SE VASCULAR CLOSURE SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·July 18, 2013
PLATE, FIXATION, BONE
FDA Adverse Event
Malfunction
·SYNTHES (USA)·Product code HRS·April 9, 2015
PLATE, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code HRS·April 9, 2015
Philips Azurion system; Software Version Number: R3.1;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·January 28, 2026