14 results
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17ms
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Sources: EU EUDAMED, US FDA
Filters
Country: Sweden
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COOL CUT
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Cooling Pad Thigh Large
Device
EU MDR
·
Eu Md Class 1
·BrainCool AB·On the market
Cooling Pad Torso Large
Device
EU MDR
·
Eu Md Class 1
·BrainCool AB·On the market
Cooling Pad Torso Medium
Device
EU MDR
·
Eu Md Class 1
·BrainCool AB·On the market
Cooling Pad Torso Small
Device
EU MDR
·
Eu Md Class 1
·BrainCool AB·On the market
Cooling Pad Thigh Small/Medium
Device
EU MDR
·
Eu Md Class 1
·BrainCool AB·On the market
Cooling Pad Head/Neck Large
Device
EU MDR
·
Eu Md Class 1
·BrainCool AB·On the market
Cooling Pad Head/Neck Medium
Device
EU MDR
·
Eu Md Class 1
·BrainCool AB·On the market
Cooling Pad Head/Neck Small
Device
EU MDR
·
Eu Md Class 1
·BrainCool AB·On the market
Cooling Pad Torso Medium/Large
Device
EU MDR
·
Eu Md Class 1
·BrainCool AB·On the market·3 countries
DigniCap Scalp Cooling System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Cooling Pad Head/Neck X-Small
Device
EU MDR
·
Eu Md Class 1
·BrainCool AB·On the market·2 countries
Tranberg Laser Applicator Non-cooled, 1.7mm/ 15G, 15 mm, Diffuser, 12 m, REF: 4017-02, Rx Only, Sterile EO - Product Usage: used with the Tranberg¿ MR Introducer; a device used to aid the insertion of the Laser Applicator into the tissue.
FDA Enforcement
Class II
·Terminated·CLINICAL LASERTHERMIA SYSTEMS AB·June 9, 2021
Cooling Pad
Basic UDI-DI
EU MDR
·
Eu Md Class 1
·BrainCool AB·10 devices