19 results
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31ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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FDA 510(k)
FDA Class 2
·Radiology
HHM
FDA UDI
Oticon A/S·05707131258380·H160, MINIRITE 312 WL CNB HHM
LEONE SPA
FDA UDI
LEONE SPA·08033707067221·LIGATURES MINI modules TRANSP LARGE
ORION E ALLOY
FDA 510(k)
FDA Class 2
·Dental
GLUCOSE SHEPHERD BLOOD GLUCOSE MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 15, 2026
PERIPHERAL NERVE BLOCK SUPPORT TRAY
FDA Adverse Event
Malfunction
·I-FLOW, LLC·Product code CAZ·October 1, 2014
ENDOTAK RELIANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVY·October 1, 2014
SYNCHROMED II
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·May 29, 2013
SYSTEM 6 SAGITTAL SAW
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS KALAMAZOO·Product code KIJ·June 11, 2011
CONTINUOUS TRAY WITH 100MM NEEDLE, STIMULATING
FDA Adverse Event
Malfunction
·I-FLOW LLC·Product code CAZ·October 2, 2014
CONTINUOUS TRAY WITH 100MM NEEDLE 4IN ECHO NEE
FDA Adverse Event
Malfunction
·I-FLOW LLC·Product code CAZ·October 3, 2014
CONTINUOUS TRAY WITH 100MM NEEDLE, NON STIMULA
FDA Adverse Event
Malfunction
·I-FLOW LLC·Product code CAZ·October 1, 2014
PERIPHERAL NERVE BLOCK SUPPORT TRAY : CONTINUEOUS TRAY 100MM NEEDLE STIMULATING
FDA Adverse Event
Malfunction
·HALYARD - IRVINE·Product code CAZ·May 12, 2015
CONTINUOUS TRAY WITH 100MM NEEDLE STIMULATING & 61CM CATHETER
FDA Adverse Event
Malfunction
·HALYARD HEALTH - IRVINE·Product code CAZ·November 8, 2015
CONTINUOUS TRAY WITH 100MM NEEDLE STIMULATING
FDA Adverse Event
Malfunction
·HALYARD - IRVINE·Product code CAZ·July 1, 2015
ECHOBRIGHT T-BLOC TRAY 100MM NEEDLE, NON STIMU
FDA Adverse Event
Malfunction
·HALYARD·Product code CAZ·April 7, 2015
ECHOBRIGHT T-BLOC TRAY 100MM NEEDLE, NON STIMU
FDA Adverse Event
Malfunction
·HALYARD·Product code CAZ·April 7, 2015
Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Ingenuity Core, Ingenuity Core 128, Ingenuity CT 728321 - Ingenuity Core 728323 - Ingenuity Core 128 728326/728327 - Ingenuity CT
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·July 7, 2021