10 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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THERMOFLO HCH, THERMOFLO FILTER
FDA 510(k)
FDA Class 2
·Anesthesiology
Phonak
FDA UDI
Phonak AG·07612847819078·Phonak Ambra SP (purple transparent)
CANNULATED PLUS SCREW SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
WHEELCHAIR, MODELS H001A, 4422
FDA 510(k)
FDA Class 1
·Physical Medicine
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 17, 2025
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·May 2, 2013
FREESTYLE
FDA Adverse Event
Injury
·Product code LFR·September 15, 2014
EASYOUT
FDA Adverse Event
Malfunction
·DEPUY ORTHOPAEDICS, INC.·Product code LXH·April 27, 2011
HARMONIC ACE 36 CM
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY, LLC.·Product code LFL·December 16, 2019
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
FDA Enforcement
Class II
·Terminated·Belmont Instrument Corporation·October 24, 2012