12 results
·
23ms
·
Sources: EU EUDAMED, US FDA
Calcium2
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ALINITY C CALCIUM2
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code CJY·March 5, 2026
ZEOS
FDA UDI
SANTA BARBARA IMAGING SYSTEMS, INC.·00812231032305·HIP BLUNT OBTURATOR
INTERSTIM II
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·November 9, 2012
MOLLI 2 System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
EFAI Bonesuite XR Bone Age Pro Assessment System (BAP-XR-100)
FDA 510(k)
FDA Class 2
·Radiology
INTERSTIM II
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·October 19, 2013
INTERSTIM II
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO·Product code EZW·January 6, 2012
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·September 12, 2011
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·November 11, 2014
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 24, 2013
SEE H-10
FDA Adverse Event
Injury
·STAAR SURGICAL COMPANY·Product code HQL·June 30, 2015