36 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Invacare Platinum 5NXG Oxygen Concentrator
FDA 510(k)
FDA Class 2
·Anesthesiology
Ophthalmic Knife
FDA UDI
KATENA PRODUCTS, INC.·00841668113271·STAB KNIFE 15 DEGREE (BX/5)
Responsive Respiratory
FDA UDI
RESPONSIVE RESPIRATORY, INC.·00851440007728·Adult Nebulizer Kit w/ Mouthpiece
UNIVERSAL NEURO 2
FDA UDI
Stryker Leibinger GmbH & Co. KG·07613154750566·LOW PROFILE PLATE, WITH TAB
Needle aspiration and injection
FDA UDI
KATENA PRODUCTS, INC.·00841668113592·PERIBULBAR NEEDLE 25GA 16MM
KARL STORZ MODEL 203210 O1 UNIMAT PLUS
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
SEEDLINKS, MODELS 70301, 70302, 70303
FDA 510(k)
FDA Class 2
·Radiology
TYVEK SELF-SEAL POUCHES WITH STERRAD, TYVEK ROLLS WITH STERRAD, TYVEK HEAT-SEAL WITH STERRAD CHEMICAL INDICATORS
FDA 510(k)
FDA Class 2
·General Hospital
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·December 16, 2022
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·February 14, 2022
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 30, 2025
LIFEVEST WCD 3000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·October 9, 2008
ENRHYTHM DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code DXY·August 11, 2011
TOTAL ASR ACET IMP SIZE 48
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD - 8010379·Product code KWA·July 2, 2013
SPRINT FIDELIS
FDA Adverse Event
Death
·MEDTRONIC, INC.·Product code LWS·July 17, 2012
TRUE METRIX
FDA Adverse Event
Malfunction
·TRIVIDIA HEALTH INC·Product code NBW·December 14, 2021
CAPSUREFIX NOVUS LEAD MRI SURESCAN
FDA Adverse Event
Injury
·MEDTRONIC, INC.·Product code DTB·August 12, 2024
ULTRATHANE BILIARY DRAINAGE CATHETER
FDA Adverse Event
Injury
·COOK INC·Product code FGE·August 11, 2020
ULTRATHANE BILIARY DRAINAGE CATHETER
FDA Adverse Event
Injury
·COOK INC·Product code GBO·August 11, 2020
ULTRATHANE BILIARY DRAINAGE CATHETER
FDA Adverse Event
Injury
·COOK INC·Product code FGE·August 11, 2020