14 results
·
22ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Gmate Origin Blood Glucose Monitoring System
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ProLift
FDA UDI
Life Spine, Inc.·00190837106232·Static Expandable Cage Trial, 10mm x 28mm x 9mm...
EVACUATED CONTAINER
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code GCY·January 14, 2022
EVACUATED CONTAINER
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code GCY·January 14, 2022
INFINITY ALPHA
FDA 510(k)
FDA Class 2
·Cardiovascular
WATERLASE MD TURBO PLUS MODEL 7200XXX
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
BD ANGIOCATH¿ IV CATHETER
FDA Adverse Event
Malfunction
·BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.·Product code FOZ·December 19, 2017
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·October 8, 2014
PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE
FDA Adverse Event
Injury
·RICE CREEK MFG·Product code LWP·June 7, 2013
ACCU-CHEK SPIRIT
FDA Adverse Event
Injury
·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code LZG·June 28, 2011
EVACUATED CONTAINER
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code GCY·January 18, 2022
BD ANGIOCATH IV CATHETER 20GA 1.88IN
FDA Adverse Event
Malfunction
·BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.·Product code FOZ·June 24, 2020
BD INSYTE¿ PERIPHERAL VENOUS CATHETER
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FOZ·March 20, 2018
SL & SLi Series (Mod 15/18/20/25) Linear Accelerator Used for radiation therapy treatments of malignant neoplastics diseases.
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·March 26, 2014