13 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Atlas SPEEDER Header/Neck
FDA 510(k)
FDA Class 2
·Radiology
CDI™ Blood Parameter Monitoring System 500
FDA UDI
Terumo Cardiovascular Systems Corporation·00886799000397·Interface cable for TCVS Sarns 8000
OSS™ Orthopedic Salvage System
FDA UDI
Biomet Orthopedics, LLC·00880304674653·
Castroviejo Troutman Needle Holder
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896111868·Castroviejo Troutman Needle Holder With Lock De...
BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO., (BD)·Product code JKA·November 27, 2019
INTELLIVUE PATIENT MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
THE SONOACE R3 DIAGNOSTIC ULTRASOUND SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 6, 2011
BARD MONOPTY
FDA Adverse Event
Malfunction
·BARD PERITONEAL VASCULAR INC.·Product code KNW·June 4, 2013
VERSACARE
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·September 10, 2008
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
Integrity 1.1. Integrity is the interface and control software for the Elekta range of medical digital linear accelerators and is intended to assist a licensed practitioner in the delivery of radiation to defined target volumes.
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·April 9, 2014
Medtronic MiniMed(TM) Mio(TM) (MMT-921, 921T, 923, 923T, 925, 925T, 941, 941T, 943, 943T, 945, 945T, 961, 963, 963T, 965, 965T, 975, 975T)
FDA Enforcement
Class II
·Ongoing·Medtronic Inc.·November 29, 2017