243 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Revive Reusable Bladder Support
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Vanguard® Knee System
FDA UDI
Biomet Orthopedics, LLC·00880304271258·
Vanguard Knee System
FDA UDI
Biomet Orthopedics, LLC·00880304466173·
CARESENS N BLOOD GLUCOSE MONITORING SYSTEM, CARESENS N METER, MODEL GM5051A OR GM5051B OR GM5051C (COLOR)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
STOCKERT CENTRIFUGAL PUMP (SCP PLUS) (COMPLETE) OR (FOR S5/C5 SYSTEMS)
FDA 510(k)
FDA Class 2
·Cardiovascular
EVOLUTION DUODENAL CONTROLLED-RELEASE STENT - UNCOVERED
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code MUM·December 10, 2019
EVOLUTION® COLONIC CONTROLLED-RELEASE STENT - UNCOVERED
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code MQR·April 7, 2022
EVOLUTION COLONIC CONTROLLED-RELEASE STENT - UNCOVERED
FDA Adverse Event
Injury
·COOK IRELAND LTD·Product code MQR·June 15, 2021
530G INSULIN PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·October 18, 2014
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 22, 2013
OT ULTRA2 METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·July 29, 2011
EVOLUTION DUODENAL CONTROLLED-RELEASE STENT - UNCOVERED
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code MUM·September 9, 2019
EVOLUTION® COLONIC CONTROLLED-RELEASE STENT - UNCOVERED
FDA Adverse Event
Injury
·COOK IRELAND LTD·Product code MQR·October 18, 2018
EVOLUTION® COLONIC CONTROLLED-RELEASE STENT - UNCOVERED
FDA Adverse Event
Injury
·COOK IRELAND LTD·Product code MQR·August 20, 2020
EVOLUTION® DUODENAL CONTROLLED-RELEASE STENT - UNCOVERED
FDA Adverse Event
Injury
·COOK IRELAND LTD·Product code MUM·September 1, 2020
EVOLUTION® COLONIC CONTROLLED-RELEASE STENT - UNCOVERED
FDA Adverse Event
Injury
·COOK IRELAND LTD·Product code MQR·August 20, 2020
EVOLUTION® COLONIC CONTROLLED-RELEASE STENT - UNCOVERED
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code MQR·May 31, 2019
EVOLUTION® COLONIC CONTROLLED-RELEASE STENT - UNCOVERED
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code MQR·April 25, 2019
EVOLUTION® DUODENAL CONTROLLED-RELEASE STENT - UNCOVERED
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code MUM·February 15, 2023
EVOLUTION® COLONIC CONTROLLED-RELEASE STENT - UNCOVERED
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code MQR·January 5, 2024