10 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Country: Sweden
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P-BAG, UNI-BAG
Device
EU MDD
·
Eu Md Class 1
·Swedish Hospital Supply AB·On the market·12 countries
P-BAG SAP
Device
EU MDD
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Eu Md Class 1
·Swedish Hospital Supply AB·On the market·13 countries
KIDDIEGAIT BABY NFR BAG
Device
EU MDR
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Eu Md Class 1
·Camp Scandinavia AB·On the market
Lightweight Bag (Vivo 45)
Device
EU MDR
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Eu Md Class 1
·Breas Medical AB·On the market·20 countries
Lightweight Mobility Bag Vivo 1-2-3
Device
EU MDR
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Eu Md Class 1
·Breas Medical AB·On the market·19 countries
P-BAG, UNI-BAG
Basic UDI-DI
EU MDD
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Eu Md Class 1
·Swedish Hospital Supply AB·1 device
P-BAG SAP
Basic UDI-DI
EU MDD
·
Eu Md Class 1
·Swedish Hospital Supply AB·1 device
KIDDIEGAIT BABY NFR BAG
Basic UDI-DI
EU MDR
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Eu Md Class 1
·Camp Scandinavia AB·1 device
Elekta Disposable Biopsy Needle Kit for Leksell Stereotactic System, REF 911933, 2.1mm Diameter / 14 Gauge, containing 6 inner boxes labeled REF 911761, Disposable Biopsy Needle Kit for Leksell Stereotactic System. Each inner box of REF 911761 contains a Tyvek bag labeled REF 912465, Disposable Biopsy Needle and Aspirator Tube.
FDA Enforcement
Class I
·Ongoing·Elekta Instrument AB·April 24, 2024
Elekta Disposable Biopsy Needle Kit for Leksell Stereotactic System, REF 911933, Diameter / 14 Gauge, containing 6 inner boxes labeled REF 911761, Disposable Biopsy Needle Kit for Leksell Stereotactic System. Each inner box of REF 911761 contains a Tyvek bag labeled REF 912465, Disposable Biopsy Needle and Aspirator Tube. The system is used for for localization and diagnosis of intracranial disorders and their surgical treatment including radiosurgery and stereotactic radiation therapy.
FDA Enforcement
Class I
·Ongoing·Elekta Instrument AB·November 13, 2024