10,000 results
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36ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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IO-FLEX
FDA UDI
SPINAL ELEMENTS·00840916103804·IO-Flex Neuro Check® w/ Wire
AESTHETIC ABUTMENTS
FDA UDI
DENTIN IMPLANTS TECHNOLOGIES LTD·07290113354098·Straight Curve Wide Three
BAXANO IO-FLEX SYSTEM
FDA Adverse Event
Other
·BAXANO, INC.·Product code HAE·July 2, 2012
BAXANO IO-FLEX SYSTEM
FDA Adverse Event
Other
·BAXANO, INC.·Product code HAE·July 2, 2012
BAXANO IO-FLEX SYSTEM
FDA Adverse Event
Other
·BAXANO, INC.·Product code HAE·July 2, 2012
BAXANO IO-FLEX WIRE (PACKAGED WITH IO-NCW)
FDA Adverse Event
Other
·BAXANO, INC.·Product code HAE·January 10, 2012
LIGHT HEAD E 668 NC W/O PAD
FDA Adverse Event
Malfunction
·BERCHTOLD CORP·Product code FSY·December 28, 2015
AUTOSOFT XC
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·August 16, 2024
GENTEK¿ HEXALOBULAR SCREWDRIVER, 21 MM
FDA Adverse Event
Malfunction
·ZIMVIE US CORP LLC·Product code NDP·January 9, 2026
VOYAGER NC CORONARY DILATATION CATHETER
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code LOX·March 10, 2011
Atellica IM HER-2/neu (H2n) assay, 50 Test Kit, Catalog No. SMN 10995591, UDI Codes: (01)00630414599151(10)98034139(17)20210130 and (01)00630414599151(10)32478139(17)20210130 Atellica IM HER-2/neu (H2n) calibrator, 2 Pack, Catalog No. SMN 10995592, UDI Code (01)00630414599168(10)22695A49(17)20201211 ADVIA Centaur HER-2/neu (H2n) assay, 50 Test Kit, Catalog No. SMN 10308994, UDI codes : (01)00630414471235(10)43157138(17)20210130 (01)00630414471235(10)81653138(17)20210130 (01)00630414471235(10)99728138(17)20210130 (01)00630414471235(10)24043138(17)20210130 (01)00630414471235(10)32477138(17)20210130 Advia Centaur Systems HER-2/neu (H2n) calibrator, 2 Pack, Catalog No. SMN 10308993, UDI Codes: (01)00630414471228(10)64661A48(17)20201112 (01)00630414471228(10)81211A48(17)20201112 (01)00630414471228(10)91743A48(17)20201112 (01)00630414471228(10)22124A49(17)20201211 Product Usage: This product is intended to be used for in vitro diagnostic use in calibrating the ADVIA Centaur systems HER-2/neu assay.
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc·Product code NCW·August 25, 2020
System, Test, Her-2/Neu, Monitoring
FDA classification
FDA Class 2
·System, Test, Her-2/Neu, Monitoring
DCW Carson
FDA registration
DCW Carson·2 products·🇺🇸 United States
NCS LAB SRL
FDA registration
NCS LAB SRL·6 products·🇮🇹 Italy
NCC (UK) LTD
FDA registration
NCC (UK) LTD·2 products·🇬🇧 United Kingdom
BCW ADVANTAGE WHEELCHAIR
FDA 510(k)
FDA Class 1
·Physical Medicine
WHEELCHAIR BCW 6000
FDA 510(k)
FDA Class 1
·Physical Medicine
Band Assemblies
FDA UDI
Ortho Organizers, Inc.·00190707129989·Elite.022/.045 UR6 Conv TplBT Epic/Sheath 4
Elite
FDA UDI
Ortho Organizers, Inc.·00190707148942·Elite.022/.045 UR6 Conv Tpl BT Epic/Sheath 3
Elite
FDA UDI
Ortho Organizers, Inc.·00190707148935·Elite.022/.045 UL6 Conv Tpl BT Epic/Sheath 3