135 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Country: Germany
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PALACOS R pro, PALACOS R+G pro, PALACOS MV+G pro
FDA 510(k)
FDA Class 2
·Orthopedic
PALACOS R, PALACOS R pro, PALACOS R+G, PALACOS R+G pro, PALACOS MV+G
FDA 510(k)
FDA Class 2
·Orthopedic
Brand Name: PALACOS Product Name: PALACOS MV+G pro 40; PALACOS MV+G pro 80 Model/Catalog Number: 5081290; 5081291 Software Version: N/A Product Description: Radiopaque, poly(methyl methacrylate)-based (PMMA) bone cement, pre-filled into a mixing and application system, suitable for use with or without vacuum (ready to mix). Component: N/A
FDA Enforcement
Class II
·Ongoing·Heraeus Medical GmbH (Dental Division)·January 21, 2026
MAG & More GmbH
Manufacturer
🇩🇪 Germany·4 Basic UDI-DIs·40 Devices
HB-580/3 MBG
Device
EU MDR
·
Eu Md Class 1
·AGA Sanitätsartikel GmbH·On the market·32 countries
HB-580/2 MBG
Device
EU MDR
·
Eu Md Class 1
·AGA Sanitätsartikel GmbH·On the market·32 countries
MutaCLEAN® Mag RNA/DNA
Device
EU IVDR
·
Eu Ivd Class A
·Immundiagnostik AG·On the market
MutaCLEAN® Mag RNA/DNA
Device
EU IVDR
·
Eu Ivd Class A
·Immundiagnostik AG·On the market
MAG & MORE GMBH
FDA registration
MAG & MORE GMBH·2 products·🇩🇪 Germany
Apollo TMS Therapy System 220 V
Device
EU MDR
·
Eu Md Class 2a
·MAG & More GmbH·On the market·12 countries
Apollo TMS Therapy System 100 V
Device
EU MDR
·
Eu Md Class 2a
·MAG & More GmbH·On the market·12 countries
Apollo TMS Therapy System 115 V
Device
EU MDR
·
Eu Md Class 2a
·MAG & More GmbH·On the market·12 countries
Apollo TMS Therapy System 230 V
Device
EU MDR
·
Eu Md Class 2a
·MAG & More GmbH·On the market·12 countries
Stimware light TBS EMG AutoMT
Device
EU MDR
·
Eu Md Class 2a
·MAG & More GmbH·On the market·1 country
Stimware TBS EMG AutoMT
Device
EU MDR
·
Eu Md Class 2a
·MAG & More GmbH·On the market·1 country
Stimware TBS light
Device
EU MDR
·
Eu Md Class 2a
·MAG & More GmbH·On the market·1 country
Stimware FDA
Device
EU MDR
·
Eu Md Class 2a
·MAG & More GmbH·On the market·1 country
Apollo Stimware TBS EMG AutoMT
Device
EU MDR
·
Eu Md Class 2a
·MAG & More GmbH·On the market·12 countries
Apollo Stimware 30 EMG AutoMT
Device
EU MDR
·
Eu Md Class 2a
·MAG & More GmbH·On the market·12 countries
Apollo Stimware TBS
Device
EU MDR
·
Eu Md Class 2a
·MAG & More GmbH·On the market·12 countries