11 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ESTELITE SIGMA QUICK
FDA 510(k)
FDA Class 2
·Dental
CoRoent
FDA UDI
Nuvasive, Inc.·00887517320469·CoRoent® LO Ti, 9x10x40mm 5°
SchureMed
FDA UDI
SCHUERCH CORPORATION·00810014608457·BERCHTOLD 4" DELUXE
SEALAPEX 4
FDA 510(k)
FDA Class 2
·Dental
HUMAN SERUM ALBUMIN (HSA)
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
HAHN TAPERED IMPLANT Ø4.3 X 10MM
FDA Adverse Event
Injury
·PRISMATIK DENTALCRAFT, INC.·Product code DZE·July 13, 2023
1 ML BD¿ LUER SLIP TIP SYRINGE WITH ATTACHED NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·January 7, 2022
HEARTMATE II LVAD
FDA Adverse Event
Injury
·THORATEC CORP.·Product code DSQ·April 17, 2013
VASOVIEW HEMOPRO EVH SYSTEM
FDA Adverse Event
Malfunction
·MAQUET CARDIOVASCULAR, LLC.·Product code GEI·April 13, 2011
TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC·Product code NIQ·July 23, 2008
CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·August 14, 2024