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