102 results
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31ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Pulse Oximeter
FDA 510(k)
FDA Class 2
·Cardiovascular
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B16741914300·
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B1674191430060·
General Instruments
FDA UDI
ALPHATEC SPINE, INC.·00840180543504·Blunt Tip Stainless Steel Guidewire 30"
MLS-AC DERMA SCANNER
FDA 510(k)
FDA Class 2
·Physical Medicine
CARE PAL, MODEL CPW-10X
FDA 510(k)
FDA Class 2
·Cardiovascular
ID NOW COVID-19
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·February 24, 2021
EVOLUTION® BILIARY CONTROLLED-RELEASE STENT - FULLY COVERED
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FCG·January 3, 2017
EVOLUTION® BILIARY CONTROLLED-RELEASE STENT - FULLY COVERED
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FGE·February 2, 2016
EVOLUTION® BILIARY CONTROLLED-RELEASE STENT - FULLY COVERED
FDA Adverse Event
Injury
·COOK IRELAND LTD·Product code FGE·September 27, 2016
FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL
FDA Adverse Event
Injury
·COOK INC·Product code FGE·January 29, 2020
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 4, 2011
IVT DISPOSABLE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MALTA·Product code KPE·June 26, 2013
OPTI-PLAST XT PTA BALLOON DILATATION CATHETER
FDA Adverse Event
Malfunction
·BARD PERIPHERAL VASCULAR, INC.·Product code LIT·September 25, 2008
ID NOW COVID-19 ASSAY
FDA Adverse Event
Malfunction
·ABBOTT DAIGNOSTICS SCARBOROUGH, INC.·Product code QJR·June 28, 2021
ID NOW COVID-19 ASSAY
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC·Product code QJR·May 7, 2021
ID NOW COVID-19
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCABOROUGH·Product code QJR·September 15, 2021
EVOLUTION BILIARY CONTROLLED-RELEASE STENT-FULLY COVERED
FDA Adverse Event
Injury
·COOK IRELAND LTD·Product code FGE·March 25, 2015
EVOLUTION BILIARY CONTROLLED-RELEASE STENT - FULLY COVERED
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FGE·April 24, 2015
HARVEST(R) TERUMOBCT, BMAC2-120-01Bone Marrow Procedure Pack, REF 51423, Rx Only, STERILE EO
FDA Enforcement
Class II
·Terminated·Terumo BCT, Inc.·November 22, 2017