9 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MENTOR PATHWAY INTRODUCER/DILATOR
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Polystar Selection EDITION
FDA UDI
Merz Dental GmbH·D7091981527·anteriors; shade BL4; mould BIM6
PROCARE
FDA UDI
DJO, LLC·00888912028882·IMPAX DIABETIC SHOE INSOLE, L
On Call Sure Blood Glucose Monitoring System, On Call Sure Sync Blood Glucose Monitoring System
FDA 510(k)
FDA Class 2
·Clinical Chemistry
LIGHT DIAGNOSTICS HSV 1/2 TYPING DFA KIT
FDA 510(k)
FDA Class 2
·Microbiology
SL-PLUS
FDA Adverse Event
Injury
·SMITH&NEPHEW -SWITZERLAND·Product code KWY·February 27, 2013
2800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·January 31, 2011
COREVALVE 31MM AORTIC VALVE
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code NPT·August 5, 2014
Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.
FDA Enforcement
Class II
·Terminated·Philips North America, LLC·March 25, 2020