102 results · 31ms · Sources: EU EUDAMED, 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