13 results
·
21ms
·
Sources: EU EUDAMED, US FDA
INFUSION BROTH
FDA 510(k)
FDA Class 1
·Microbiology
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172971116·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172971208·
CAREMIBRAIN
FDA 510(k)
FDA Class 2
·Radiology
SHORT INTRODUCER SHEATH
FDA 510(k)
FDA Class 2
·Cardiovascular
TERUMO ADVANCED PERFUSION SYSTEM 1
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DTQ·March 27, 2014
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·November 14, 2012
SPRINT QUATTRO SECURE S
FDA Adverse Event
Injury
·MPRI·Product code LWS·June 10, 2015
PINNACLE MTL INS NEUT36IDX52OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC. 1818910·Product code KWA·April 3, 2014
ARTICULEZE M HEAD 36MM +5
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC. 1818910·Product code JDI·April 3, 2014
PINNACLE MTL INS NEUT36IDX52OD
FDA Adverse Event
Malfunction
·DEPUY ORTHOPAEDIC INC, 1818910·Product code KWA·January 25, 2012
PINNACLE 300 ACET CUP 52MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDIC INC, 1818910·Product code LPH·January 25, 2012
Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.
FDA Enforcement
Class II
·Terminated·Philips North America, LLC·March 25, 2020