10 results
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16ms
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Sources: EU EUDAMED, US FDA
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Country: Germany
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Aquilex Fluid Control System AQL-100S
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Aquilex Fluid Control System-Intended to provide fluid distension of the uterus during diagnostic and operative hysteroscopies and to monitor the volume differential between the irrigation fluid flowing into and out of the uterus. Models AQL-100PBS and AQL-100P
FDA Enforcement
Class II
·Ongoing·WOM World Of Medicine AG·October 4, 2023
Aquilex Fluid Control System component: Bag deflector, REF AQL-100CBS Product Usage: Distends uterus with fluid during diagnostic and operative hysteroscopies.
FDA Enforcement
Class II
·Terminated·WOM World of Medicine AG·October 9, 2019
V-OIL
Basic UDI-DI
EU MDD
·
Eu Md Class 2a
·VITROMED GmbH·1 device
Service Oil
Basic UDI-DI
EU MDR
·
Eu Md Class 1
·MK-dent GmbH·3 devices
V-OIL
Basic UDI-DI
EU MDD
·
Eu Md Class 2a
·VITROMED GmbH·1 device
V-OIL
Basic UDI-DI
EU MDD
·
Eu Md Class 2a
·VITROMED GmbH·1 device
V-OIL
Basic UDI-DI
EU MDD
·
Eu Md Class 2a
·VITROMED GmbH·1 device
GM501 Mineral Oil
Basic UDI-DI
EU MDR
·
Eu Md Class 2a
·Gynemed GmbH & Co. KG·3 devices
Sprayer, flexible nozzle (fluids & oils)
Basic UDI-DI
EU MDR
·
Eu Md Class 1
·ATMOS MedizinTechnik GmbH & Co. KG·1 device