8 results
·
25ms
·
Sources: EU EUDAMED, US FDA
OMEGA III ANGIOGRAPHIC TABLE, ROTATION & STEPPER
FDA 510(k)
FDA Class 2
·Radiology
ReddyPort NIV Access Elbow
FDA 510(k)
FDA Class 2
·Anesthesiology
ALWAYS MENSTRUAL PADS
FDA 510(k)
FDA Class 1
·Obstetrics/Gynecology
SYNCHROMED EL
FDA Adverse Event
Injury
·RICE CREEK MFG·Product code LKK·June 13, 2014
SYNCHRON CX5CE CLINICAL SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code JJE·October 16, 2010
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·December 13, 2012
SPRYSTEP VECTOR KAFO, Custom made device dynamic ankle-foot orthosis (KAFO) non locking, REF #s: 17VKCUS and 17VKCUSX
FDA Enforcement
Class II
·Completed·Townsend Design·January 17, 2024
STERRAD 100NX Sterilization System, P/N 10104 Product Usage: The STERRAD 100NX Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD 100NX process to inactivate microorganisms on a board range of medical devices and surgical instruments.
FDA Enforcement
Class II
·Terminated·Advanced Sterilization Products·April 10, 2013