30 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MODULAR ROTATING HINGE KNEE CROSSOVER TIBIAL BEARING COMPONENTS
FDA 510(k)
FDA Class 2
·Orthopedic
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·10304040061272·Screw Post Gold Plated
RMO
FDA UDI
Rmo, Inc.·00885797099686·MAX MLR BDS ASST 100 SE ASIA
ActivHeal
FDA UDI
ADVANCED MEDICAL SOLUTIONS LIMITED·15032749001545·SILICONE FOAM NON BORDER ADHESIVE 5X5CM
artVeneer life
FDA UDI
Merz Dental GmbH·D7092001548·artVeneer life lower anteriors, UCL, BL1
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970874·
LIGHT BOND (QUICK CURE)
FDA 510(k)
FDA Class 2
·Dental
MEROGEL OTOLOGIC PACK
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
TUFF UNICON IMPLANT
FDA Adverse Event
Malfunction
·NORIS MEDICAL LTD·Product code DZE·September 7, 2025
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·January 2, 2026
CHARGING SYSTEM
FDA Adverse Event
Injury
·ST JUDE MEDICAL - NEUROMODULATION·Product code LGW·March 5, 2013
OBTRYX SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·February 25, 2011
TWO-LUMEN INTRAVENOUS SET
FDA Adverse Event
Injury
·ARRROW INTERNATIONAL INC·Product code FOZ·February 21, 2008
DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code PQF·July 9, 2018
YPSOPUMP® INSET
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·October 23, 2024
Baxter Minivolume T-Connector Extension Set with 0.22 Micron High Pressure Pediatric Filter, catalog 2C5683; Baxter Healthcare Corporation, Deerfield, IL 60015; 48 units per case
FDA Recall
Terminated
·Baxter Healthcare Corp. Rt·Product code FPA·October 17, 2002
Baxter Minivolume Extension Set with 0.22 Micron High Pressure Pediatric Filter, catalog 2C5693; Baxter Healthcare Corporation, Deerfield, IL 60015; 48 units per case
FDA Recall
Terminated
·Baxter Healthcare Corp. Rt·Product code FPA·October 17, 2002
AUTOSOFT XC
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·July 17, 2024
AUTOSOFT XC
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·July 17, 2024
AUTOSOFT XC
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·July 17, 2024