7 results
·
33ms
·
Sources: EU EUDAMED, US FDA
THIO W/SUPPLEMENT
FDA 510(k)
FDA Class 1
·Microbiology
GUM MACHINE
FDA 510(k)
FDA Class 1
·Dental
VENTURE II MONITORING SYSTEM
FDA 510(k)
FDA Class 1
·Cardiovascular
OT VERIO TEST STRIPS
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 28, 2014
ACCU-CHEK ® MULTICLIX
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code FMK·November 15, 2012
HYDRATOME RX SPHINCTEROTOME
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - SPENCER·Product code KNS·September 14, 2010
PSS Select medical products***Biopsy Punches*** Disposable manual instrument for skin biopsy.
FDA Enforcement
Class II
·Terminated·Clorox Healthcare Holdings, LLC (dba HealthLink)·July 10, 2013