15 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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HYPAFIX DRESSING RETENTION SHEET
FDA 510(k)
FDA Class 1
·General Hospital
LONESTAR
FDA UDI
Orthofix US LLC·18257200090433·DIA 4.0MM X 16MM RESCUE BONE SCREW - SELF TAPPING
CARTO 3 EP NAVIGATION SYSTEM, VERSION 4.2
FDA 510(k)
FDA Class 2
·Cardiovascular
GRI-BAG, GRI-BAG AP
FDA 510(k)
FDA Class 2
·General Hospital
DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SANTIAGO·Product code KPO·May 27, 2014
BRAVO
FDA Adverse Event
Malfunction
·GIVEN IMAGING LTD.·Product code FFT·November 7, 2012
ATTAIN PERFORMA
FDA Adverse Event
Injury
·MPRI·Product code OJX·June 10, 2015
CARTO® 3 SYSTEM
FDA Adverse Event
Malfunction
·BIOSENSE WEBSTER INC·Product code DQK·May 21, 2024
CARTO® 3 SYSTEM
FDA Adverse Event
Malfunction
·BIOSENSE WEBSTER INC·Product code DQK·June 3, 2024
CARTO® 3 SYSTEM
FDA Adverse Event
Malfunction
·BIOSENSE WEBSTER INC·Product code DQK·April 17, 2024
CARTO® 3 SYSTEM
FDA Adverse Event
Malfunction
·BIOSENSE WEBSTER INC·Product code DQK·June 3, 2024
CARTO® 3 SYSTEM
FDA Adverse Event
Malfunction
·BIOSENSE WEBSTER (ISRAEL) LTD.·Product code DQK·December 22, 2016
CARTO® 3 SYSTEM
FDA Adverse Event
Malfunction
·BIOSENSE WEBSTER INC·Product code DQK·January 10, 2024
Isopure Sodium Bicarbonate Mixing and Distribution System (IsoMix PRO)
FDA Enforcement
Class II
·Ongoing·Isopure Corp·July 20, 2022
Zimmer, Cuff Tourniquet Dual Hose Single Bladder Maroon Reprocessed by Sterilmed, Sterile EO, Rx only.
FDA Enforcement
Class II
·Terminated·STERILMED, INC.·December 16, 2015