8 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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NA ALPHA 1 MICROGLOBULIN KIT
FDA 510(k)
FDA Class 2
·Immunology
Natural Profile Healing Abutment 5.0mm x 3.0mm, RP, Ti
FDA UDI
STERNGOLD DENTAL LLC·00841549110740·Devices are used in dental implant applications...
ESCORT MODEL 400T TELEMETRY ECG MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
CATHSCANNER(R) PTA BALLOON DILATATION CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
FLOGARD
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·January 9, 2013
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
FDA Adverse Event
Malfunction
·COCHLEAR LTD.·Product code MCM·November 22, 2010
ENDOTAK RELIANCE
FDA Adverse Event
Malfunction
·GUIDANT PUERTO RICO BV·Product code NVY·July 1, 2014
Pipeline Flex Embolization Device
FDA Enforcement
Class I
·Ongoing·Micro Therapeutics Inc,·September 15, 2021