21 results · 23ms · Sources: EU EUDAMED, US FDA

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Tri-Ex Extraction Balloon with Multiple Sizing

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

CoRoent

FDA UDI
Nuvasive, Inc.·00887517568267·CoRoent Ant TLIF PEEK, 9x13x34mm 4°

INFUSION SETS

FDA 510(k)
FDA Class 2 ·General Hospital

STEREOS WORKSTATION

FDA 510(k)
FDA Class 2 ·Radiology

PRIM SYM SET 2 CL W/FILTERTEK VALVE

FDA Adverse Event
Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·March 21, 2012

PRIM SYM SET 2 CL W/FILTERTEK VALUE

FDA Adverse Event
Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FPA·February 21, 2012

PRIM SYM SET 2 CL W/FILTERTEK VALVE

FDA Adverse Event
Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·July 9, 2012

RESOLUTION CLIP DEVICE

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code MND·October 7, 2008

CERCL-CABLE W/CRIMP Ø1.7

FDA Adverse Event
Malfunction ·SYNTHES, USA·Product code LRN·June 27, 2013

MESH - COMPOSIX KUGEL

FDA Adverse Event
Injury ·DAVOL INC.·Product code FTL·July 26, 2011

PRIM SYM SET 2 CL W/FILTERTEK VALVE

FDA Adverse Event
Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FPA·February 14, 2012

PRIM SYM SET 2 CL W/FILTERTEK VALVE

FDA Adverse Event
Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FPA·July 5, 2012

PRIM SYM SET 2 CL W/FILTERTEK VALVE

FDA Adverse Event
Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·July 5, 2012

PRIM SYM SET 2 CL W/FILTERTEK VALVE

FDA Adverse Event
Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·July 5, 2012

PRIM SYM SET2 CL W/FILTERTEK VALVE

FDA Adverse Event
Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·July 5, 2012

COBAS E 411 RACK

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·December 30, 2021

PRIM SYM SET 2 CL W/ FILTERTEK VALVE

FDA Adverse Event
Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FPA·July 5, 2012

PRIM SYM SET 2 CL W/FILTERTEK VALVE

FDA Adverse Event
Malfunction ·HOSPIRA COSTA RICA LTD·Product code FPA·January 16, 2012

PRIM SYM 2 CL W/FILTERTEK VALVE

FDA Adverse Event
Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FPA·February 21, 2012

St. Jude Medical CONFIRM Rx Insertable Cardiac Monitor, Sterile EO, Model #: DM3500 The Confirm Rx ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.

FDA Enforcement
Class II ·Terminated·St Jude Medical Inc.·July 11, 2018