17 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Puritan Bennett 840 Series Ventilator System
FDA 510(k)
FDA Class 2
·Anesthesiology
840 VENTILATOR
FDA Adverse Event
Injury
·COVIDIEN·Product code CBK·June 20, 2017
840 VENTILATOR
FDA Adverse Event
Injury
·COVIDIEN·Product code CBK·August 1, 2017
840 VENTILATOR
FDA Adverse Event
Malfunction
·COVIDIEN·Product code CBK·July 25, 2017
840 VENTILATOR
FDA Adverse Event
Malfunction
·COVIDIEN·Product code CBK·August 17, 2017
840 VENTILATOR
FDA Adverse Event
Malfunction
·COVIDIEN·Product code CBK·March 21, 2017
840 VENTILATOR
FDA Adverse Event
Injury
·COVIDIEN·Product code CBK·June 26, 2017
Oticon
FDA UDI
Oticon A/S·05707131287991·ALTA2 PRO, DESIGNRITE 10 WL CRED
CUSA EXCEL 23KHZ TUBING SET
FDA Adverse Event
Malfunction
·INTEGRA LIFESCIENCES (IRELAND) LTD.·Product code LFL·November 24, 2015
NEOTRACT ANCHOR SYSTEM MODEL: REF 11208
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MICROPUMP MP-101
FDA 510(k)
FDA Class 2
·General Hospital
BD TUBE SST PLH 13X100 5.0 PLBL GOLD BR
FDA Adverse Event
Malfunction
·BECTON DICKINSON IND. CIRURGICAS LTDA·Product code JKA·April 21, 2023
CONNECSCR F/INSERTION DHS BLADE
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code LXH·June 7, 2013
UNKNOWN HIP HEAD
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWY·June 30, 2011
COLIBRI
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HWE·October 8, 2014
Medical Linear Accelerator
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·September 14, 2016
cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Corporation·March 14, 2018