21 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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INOMAX DSIR (DELIVERY SYSTEM)
FDA 510(k)
FDA Class 2
·Anesthesiology
ArgenIS
FDA UDI
ARGEN CORPORATION, THE·D818131686·TiBase MS NP .8G E
3.5MM CORTEX SCREW SELF-TAPPING 55MM
FDA Adverse Event
Injury
·SYNTHES MONUMENT·Product code HWC·January 26, 2017
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HWC·July 25, 2018
FDR IMAGE STITCHING OPTION
FDA 510(k)
FDA Class 2
·Radiology
AEROMIST LT, MODEL HCS15004
FDA 510(k)
FDA Class 2
·Anesthesiology
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES USA·Product code HWC·November 18, 2015
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HWC·June 7, 2018
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 28, 2025
3.5MM CORTEX SCREW SELF-TAPPING 16MM
FDA Adverse Event
Injury
·SYNTHES USA·Product code HWC·January 6, 2016
3.5MM CORTEX SCREW SELF-TAPPING 14MM
FDA Adverse Event
Injury
·SYNTHES USA·Product code HWC·January 6, 2016
FINELINE II
FDA Adverse Event
Malfunction
·CPI - DEL CARIBE·Product code DTB·October 1, 2014
BONE HOLDING FORCEPS SELF-CENTER SOFTLO
FDA Adverse Event
Malfunction
·SYNTHES USA·Product code HTD·May 29, 2013
CARELINK PROGRAM W/TELEMETRY C
FDA Adverse Event
Malfunction
·MEDTRONIC, INC.·Product code DXY·June 16, 2011
CORTSCR 3.5 SELF-TAP L65 TI
FDA Adverse Event
Malfunction
·SYNTHES (USA)·Product code HWC·April 29, 2013
3.5MM CORTEX SCREW SELF-TAPPING 22MM
FDA Adverse Event
Injury
·SYNTHES USA·Product code HWC·December 21, 2015
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code HWC·January 4, 2016
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES USA·Product code HWC·July 14, 2016
3.5MM TI CORTEX SCREW 36MM
FDA Adverse Event
Malfunction
·SYNTHES TRAUMA : OBERDORF : SYNTHES PRODUKTIONS GM·Product code HWC·February 9, 2018
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