9 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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IntelliCartTM System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PILLING
FDA UDI
TELEFLEX INCORPORATED·24026704399523·
EMG SUCTION UNIT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MENTOR RESTERILIZABLE GEL BREAST IMPLANT SIZER
FDA 510(k)
FDA Unclassified
·Unknown
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·June 24, 2025
TERUMO ADVANCED PERFUSION SYSTEM 1
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DTQ·June 6, 2013
LIGAMAX-5MM
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code FZP·July 14, 2011
PRESTIGE IQ
FDA Adverse Event
Malfunction
·HOME DIAGNOSTICS, INC.·Product code NBW·September 9, 2008
CSI, Orbital Atherectomy System (OAS) Saline Infusion Pump, Rx only, Part Number: 7-10014, Model Number: SIP-3000.
FDA Enforcement
Class II
·Terminated·Cardiovascular Systems Inc·May 31, 2017