26 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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EPIC 10
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772813865·GENUMEDI PRO SILVER SIZE VI
SURGISTAR
FDA UDI
SURGISTAR, INC.·00878799006721·
ArgenZ Anterior 95x25 #2
FDA UDI
ARGEN CORPORATION, THE·D818121286·Dental porcelain/ceramic restoration kit
NOVO Health Services, LLC
FDA UDI
NOVO HEALTH SERVICES, LLC·00812564032096·BROWARD LIVER TRANSPLANT PK
Ambler Surgical
FDA UDI
AMBLER SURGICAL CORP.·10190660198579·Anterior chamber rycroft cannula, 27 gauge x 6....
MICROSELECTRON HDR- GENIE AFTERLOADING SYSTEM, MODEL 105.989 FOR 115VOLT DEVICES AND 105.988 FOR 230VOLT DEVICES
FDA 510(k)
FDA Class 2
·Radiology
SEDARA GAS MIXER, SEDARA SCAVENGER MODEL: 03, 04
FDA 510(k)
FDA Class 2
·Anesthesiology
CONTOUR® PLUS
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code NBW·September 10, 2025
CONTOUR® XT
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code NBW·April 23, 2026
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 20, 2013
BIOGEL SURGEONS SZ 7.5
FDA Adverse Event
Injury
·MOLNLYCKE HEALTHCARE·Product code KGO·September 22, 2014
ACCU-CHEK ® AVIVA TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·June 13, 2011
CONTOUR® PLUS
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code NBW·May 1, 2026
CONTOUR® XT
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code NBW·May 15, 2025
CONTOUR® PLUS
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code NBW·December 31, 2025
UNK MAMMARY IMPLANT
FDA Adverse Event
Injury
·ALLERGAN (COSTA RICA)·Product code FWM·July 1, 2025
CONTOUR® NEXT
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code NBW·May 12, 2026
UNK MAMMARY IMPLANT
FDA Adverse Event
Injury
·ALLERGAN (COSTA RICA)·Product code FWM·July 1, 2025
CONTOUR® PLUS
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code NBW·September 11, 2025