81 results
·
21ms
·
Sources: EU EUDAMED, US FDA
TEMPUSIC PATIENT MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
Malecot
FDA UDI
COOK INCORPORATED·00827002144316·Malecot Nephrostomy Catheter/Stent Set
MODIFICATION TO COROMETRICS MODEL 120IS MATERNAL/FETAL MONITORING SYSTEM.
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
ULTRA CARE 2 LATEX EXAMINATION GLOVES MADE FROM ALLOTEX (ENZYME TREATED) NATURAL RUBBER LATEX WITH A PROTEIN CONTENT LAB
FDA 510(k)
FDA Class 1
·General Hospital
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·December 22, 2017
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·September 26, 2017
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS·Product code KWP·June 9, 2017
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS·Product code KWP·March 8, 2019
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 8, 2025
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·February 3, 2026
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·September 26, 2018
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS·Product code KWP·November 8, 2019
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·April 29, 2013
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·April 27, 2011
PIC
FDA Adverse Event
Malfunction
·WELCH ALLYN PROTOCOL, INC.·Product code MKJ·July 22, 2008
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS·Product code KWP·March 8, 2019
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·September 18, 2013
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS·Product code KWP·October 18, 2018
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·September 27, 2017
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS·Product code KWP·March 7, 2018