10 results
·
32ms
·
Sources: EU EUDAMED, US FDA
THERMOELASTOMER HOT/COLD COMPRESS BK7186
FDA 510(k)
FDA Class 1
·Physical Medicine
WRISTECH
FDA UDI
HEALTH & LIFE CO., LTD.·04719872480167·wrist type blood pressure monitor
VITIQUE SYSTEM
FDA 510(k)
FDA Class 2
·Dental
VERTICALE® Navigation Instruments
FDA 510(k)
FDA Class 2
·Neurology
COBAS 8000 C702 MODULE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·April 1, 2025
COBAS 8000 C 702 MODULE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·November 26, 2024
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·May 1, 2014
TURON SHOULDER
FDA Adverse Event
Other
·ENCORE MEDICAL, L.P.·Product code KWS·October 25, 2012
ACCURUS HIGH BRIGHTNESS ILLUMINATOR SYSTEM
FDA Adverse Event
Malfunction
·ALCON - IRVINE TECHNOLOGY CENTER·Product code MPA·August 27, 2010
Zimmer, Cuff Tourniquet Dual Hose Single Bladder Maroon Reprocessed by Sterilmed, Sterile EO, Rx only.
FDA Enforcement
Class II
·Terminated·STERILMED, INC.·December 16, 2015