8 results
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30ms
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Sources: EU EUDAMED, US FDA
Filters
Country: Sweden
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Sling - Amputee clip sling - “hook & loop" fastener
Device
EU MDR
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Eu Md Class 1
·ArjoHuntleigh AB·On the market·26 countries
ENTERPRISE 5000X
Device
EU MDR
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Eu Md Class 1
·ArjoHuntleigh AB·On the market·1 country
CARBON DIOXIDE (MEDICAL DEVICE) 2.5L
Device
EU MDD
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Eu Md Class 2a
·Linde Sverige AB (Linde Gas)·On the market·8 countries
CARBON DIOXIDE (MEDICAL DEVICE) 2.5L
Basic UDI-DI
EU MDD
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Eu Md Class 2a
·Linde Sverige AB (Linde Gas)·1 device
Brand Name: Catalyst+ Product Name: Catalyst, Catalyst+ Model/Catalog Number: SP001-0026, SP003-0002 Software Version: cSRS module in combination with cMotion module Product Description: GMDN: 40893 Patient positioning device, diagnostic imaging/radiotherapy, laser Component: Not applicable
FDA Enforcement
Class II
·Ongoing·C-RAD POSITIONING AB·January 21, 2026
Brand Name: Catalyst+ Product Name: C4D software used in conjunction with Catalyst (SP001-0025), Catalyst HD (SP001-0026), Catalyst PT (SP001-0027), Catalyst X4 (SP002-0035), Catalyst+ (SP003-0001), Catalyst+ HD (SP003-0002), Catalyst+ PT (SP003-0008), Catalyst+ X4, (SPOO3-0009) Product Description: Patient positioning device, diagnostic imaging/radiotherapy, laser Component: Not a component
FDA Enforcement
Class II
·Ongoing·C-RAD POSITIONING AB·June 4, 2025
PC Application Software c4D as part of the device Catalyst: SP-002 Software PA-003 version 6.1.1 and 6.1.0
FDA Enforcement
Class II
·Terminated·C-RAD POSITIONING AB·July 21, 2021
DD 2349717-1
Certificate
MDD Annex V·Linde Sverige AB (Linde Gas)·TÜV Rheinland LGA Products GmbH·1 Basic UDI-DI