10 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ADMIRE
FDA 510(k)
FDA Class 2
·Radiology
INTELLIVUE MX40 PATIENT MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
TRIFIT 700
FDA 510(k)
FDA Class 2
·Cardiovascular
OCTRODE
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 20, 2013
ENDO GIA UNIVERSAL 12MM SINGLE USE INST
FDA Adverse Event
Injury
·UNITED STATES SURGICAL·Product code GDW·June 8, 2011
840 VENTILATOR
FDA Adverse Event
Malfunction
·PURITAN-BENNETT CORP.·Product code CBK·August 20, 2008
ALTRX +4 10D 40IDX58OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code LPH·June 10, 2019
PLATE, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES USA·Product code HRS·October 3, 2016
PLATE, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code HRS·August 26, 2016
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