11 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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b-ONER MOBIO Total Knee System
FDA 510(k)
FDA Class 2
·Orthopedic
Spark™
FDA UDI
METREX RESEARCH, LLC·00850036373797·Spark™ battery pack replacement kit
HEARTSPAN STEERABLE INTRODUCER KIT
FDA 510(k)
FDA Class 2
·Cardiovascular
MEDRAD TRANSFER SET
FDA 510(k)
FDA Class 2
·General Hospital
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 14, 2025
BARDIA FOLEY CATHETER SILICONE COATED K922431
FDA Adverse Event
Injury
·C.R. BARD, INC. (COVINGTON) -1018233·Product code KOD·November 1, 2021
SYNCHROMED II
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code LKK·November 5, 2008
LIGASURE ATLAS HANDSWITCHING 37CM
FDA Adverse Event
Malfunction
·COVIDIEN LLC (SHANGHAI)·Product code GEI·July 14, 2011
UNKNOWN IMPLANTABLE NEUROSTIMULATOR
FDA Adverse Event
Malfunction
·MEDTRONIC NEUROMODULATION·Product code LGW·July 12, 2013
SMR REVERSE HUMERAL BODY SHORT
FDA Adverse Event
Injury
·LIMACORPORATE S.P.A.·Product code PHX·January 17, 2023
SURGICAL PACK CONTENTS: (1) SUTURE BAG FLORAL (1) WRAPPER 30" X 30" (2) UTILITY BOWL 16oz (1) TRAY ORGANIZER FULL DEEP (1) SPECIMEN CONTAINER 4oz W/LID & LABEL (1) YANKAUER SUCTION TUBE WITHOUT VENT (5) LAP SPONGE PREWASH 18" X 18" XRD (1) BLADE SURG. #15 CARBON STEEL (2) NEEDLE & BLADE COUNTER 1Oc MAG/CLEAR (1) CAUTERY TIP POLISHER (1) BLADE SURG. #10 CARBON STEEL (2) LITE GLOVE (10) GAUZE SPONGE 4" X 4" 16PLY XRD (1) CAUTERY PENCIL ROCKER SWITCH (1) TIME OUT BEACON NON WOVEN ST Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
FDA Enforcement
Class I
·Terminated·Customed, Inc·September 10, 2014