7 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MALLEABLE SUCTION INSTRUMENTS
FDA 510(k)
FDA Class 2
·Neurology
CONMED R SABRE GENESIS TM ELECTROSURGICAL UNIT; CONED R SABRE GENESIS TM ELECTROSURGICAL UNIT (230V); CONMED HYFRESURG O
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
VENUS FLOW
FDA 510(k)
FDA Class 2
·Dental
INTERSTIM
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code EZW·May 29, 2013
MODEL NOT SPECIFIED
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code LZG·June 9, 2011
840 VENTILATOR
FDA Adverse Event
Malfunction
·PURITAN-BENNETT CORP·Product code CBK·August 20, 2008
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