11 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DIAG FAST-CATH DUO & TRIO REMOVABLE HEMOSTASIS ADAPTERS W/SIDEPORTS & 3-WAY STOPCOCKS
FDA 510(k)
FDA Class 2
·Cardiovascular
RUMI II KOH-EFFICIENT
FDA Adverse Event
Injury
·COOPERSURGICAL, INC.·Product code HEW·October 20, 2022
AVALON GENERAL PURPOSE SCANNER, PREVIEW GP
FDA 510(k)
FDA Class 2
·Cardiovascular
MINIPAC (TM)
FDA 510(k)
FDA Class 2
·Neurology
KOH-EFFICIENT,RUMI
FDA Adverse Event
Injury
·COOPERSURGICAL, INC.·Product code HEW·November 4, 2022
KOH-EFFICIENT,RUMI
FDA Adverse Event
Injury
·COOPERSURGICAL, INC.·Product code HEW·November 3, 2022
ELECTRODE, PACEMAKER, PERMANENT
FDA Adverse Event
Injury
·MPRI·Product code DTB·February 11, 2013
ARTICULEZE M HEAD 36MM +5
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDIC INC, 1818910·Product code JDI·January 5, 2011
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 24, 2014
IMPELLA CP
FDA Adverse Event
Injury
·ABIOMED, INC.·Product code OZD·December 24, 2025
Presource PBDS, Extremity, Kit, Circulator
FDA Enforcement
Class I
·Terminated·Cardinal Health, Medical Products & Services·May 15, 2013