10 results
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32ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ADAPT for Gamma3
FDA 510(k)
FDA Class 2
·Neurology
Sklar®
FDA UDI
SKLAR CORPORATION·10649111389191·MURPHY TUBE OCCLUD FCP 6"
Skan-C Mobile C-Arm X-Ray System - 230V Variant, Skan-C Mobile C-Arm X-Ray System - 110V Variant
FDA 510(k)
FDA Class 2
·Radiology
WARMAIR MODEL 135 HYPERTHERMIA SYSTEM INCLUDING FILTEREDFLO BLANKETS
FDA 510(k)
FDA Class 2
·Cardiovascular
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 7, 2025
RIATA ST ACTIVE FIXATION
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC., CRMD·Product code NVY·October 15, 2014
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 24, 2011
DRILL BIT Ø1.5 W/STOP L44.5/6 2FLUTE
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HTW·June 17, 2013
3005180920-2018-00587
FDA Adverse Event
Injury
·July 31, 2018
DuraLife Autoclavable Double Swivel Elbow, REF 60-0010 (UltraSet Product Code 66-1991); Swivel Elbow with Suction Port for use with breathing circuits
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·May 24, 2023