11 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Plasma Edge System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MEDRAD STELLANT CT INJECTOR SYSTEM WITH XDS ACCESSORY
FDA 510(k)
FDA Class 2
·Cardiovascular
SPECTRA OPTIA R APHERESIS SYSTEM
FDA 510(k)
FDA Unclassified
·Unknown
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·June 25, 2025
Widex
FDA UDI
Widex A/S·05706069819601·Widex UNIQUE U-FS (Metallic Blue ) 50, Telecoil...
Widex
FDA UDI
Widex A/S·05706069792904·Widex UNIQUE U-PA (Metallic Blue ) 50, RC coil
ACCU-CHEK ® MULTICLIX
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code FMK·June 11, 2013
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 15, 2011
INTEGRITY
FDA Adverse Event
Injury
·DENTSPLY CAULK·Product code EBG·September 15, 2008
GMK-REVISION 02.07.10.8651 TRIAL OFFSET 3MM
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code LXH·August 2, 2023
XP-XP Tibial Tray - Interlok 83 mm Item # 195759
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·September 18, 2019