13 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
ARTISTE SOLUTION WITH SYS_VC10C AND SYNGO RT THERAPIST WORKSPACE, V4.3.1 UPGRADE KIT, ARIA CONNECTIVITY OPTION FOR SIEME
FDA 510(k)
FDA Class 2
·Radiology
Medline
FDA UDI
GRI Medical & Electronic Technology Co., Ltd.·16931918142074·Impervious Interventional Femoral Angiography D...
SIGNATURE CARE
FDA UDI
BETTER LIVING BRANDS LLC·00021130771295·ALBERTSON DIGISCAN THERMOMETER
INFRARED EAR THERMOMETER, MODELS TM819, TM820, TM817, TM810A, TM810B, TM818 AND TM818A
FDA 510(k)
FDA Class 2
·General Hospital
EPI-SCAN, MODEL P 100
FDA 510(k)
FDA Class 2
·Neurology
INTERSTIM II
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·April 6, 2012
INTERSTIM
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·January 13, 2015
INTERSTIM II
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·July 31, 2012
MITRACLIP
FDA Adverse Event
Malfunction
·ABBOTT MEDICAL·Product code NKM·September 30, 2024
ICP EXPRESS IEC
FDA Adverse Event
Injury
·CODMAN & SHURTLEFF·Product code GWM·October 1, 2014
SHILEY XLT
FDA Adverse Event
Injury
·COVIDIEN·Product code JOH·May 23, 2013
CLENZ CAPILLARY MAINTENANCE SOLUTION KIT
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code JCB·June 17, 2011
Ultraview SL Command Modules, Model 91496, with the Masimo SpO2 PCBA, PN: 010-1636-02. The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use.
FDA Enforcement
Class II
·Terminated·Spacelabs Healthcare Inc·May 13, 2015