14 results
·
19ms
·
Sources: EU EUDAMED, US FDA
CATHETER BUBBLE STAND
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Bioplate®
FDA UDI
Bioplate, Inc.·M3848134870·Drill Bit - Ø1.5 mm x 4.5 mm
HEMO-CATH 10F, HEMO-CATH 12.5F
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ACUSON P500 Ultrasound System
FDA 510(k)
FDA Class 2
·Radiology
INTERSTIM II
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·September 26, 2013
INTERSTIM II
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·April 9, 2012
INTERSTIM
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·February 4, 2014
INTERSTIM II
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·May 31, 2012
INTERSTIM II
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·October 22, 2012
INTERSTIM II
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·September 24, 2013
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·May 15, 2014
CARELINK
FDA Adverse Event
Malfunction
·MEDTRONIC, INC.·Product code KRG·October 31, 2012
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·June 2, 2015
RGDFIX FEM3.3MM ST BR XPIN KIT
FDA Adverse Event
Malfunction
·DEPUY MITEK LLC US·Product code MAI·January 21, 2019