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Endotherapy and electrosurgical devices
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Endotherapy devices
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Spinal endotherapy devices
/
Spinal percutaneous plastic devices with balloon
Spinal percutaneous plastic devices with balloon
K010301
301 devices
Aditus Kyphoplasty Working Cannula And Diamond Tip
Biopsybell SRL
·
,
Italy
Class IIa
CE/MDR
IT349638
Withdrawn
Valid to Feb 2030
CE/MDR
IT353495
Active
Valid to Jun 2031
Renova Spine Balloon Catheter
Biopsybell SRL
·
,
Italy
Class IIa
CE/MDR
IT349638
Withdrawn
Valid to Feb 2030
CE/MDR
IT353495
Active
Valid to Jun 2031
Kyphoset Balloon Catheter
Biopsybell SRL
·
,
Italy
Class IIa
CE/MDR
IT349638
Withdrawn
Valid to Feb 2030
CE/MDR
IT353495
Active
Valid to Jun 2031
Kyphokit Working Cannula And Trocar Tip
Biopsybell SRL
·
,
Italy
Class IIa
CE/MDR
IT349638
Withdrawn
Valid to Feb 2030
CE/MDR
IT353495
Active
Valid to Jun 2031
+1
authorizations
Cifopack Bone Access Needle
Biopsybell SRL
·
,
Italy
Class IIa
CE/MDR
IT353495
Active
Valid to Jun 2031
CE/MDR
IT349638
Withdrawn
Valid to Feb 2030
+1
authorizations
Kyphokit Classic Access System
Biopsybell SRL
·
,
Italy
Class IIa
CE/MDR
IT349638
Withdrawn
Valid to Feb 2030
CE/MDR
IT353495
Active
Valid to Jun 2031
+1
authorizations
Aditus Balloon Catheter
Biopsybell SRL
·
,
Italy
Class IIa
CE/MDR
IT349638
Withdrawn
Valid to Feb 2030
CE/MDR
IT353495
Active
Valid to Jun 2031
Renova Spine Fast Access System
Biopsybell SRL
·
,
Italy
Class IIa
CE/MDR
IT353495
Active
Valid to Jun 2031
CE/MDR
IT349638
Withdrawn
Valid to Feb 2030
Kyphoset Fast Access System
Biopsybell SRL
·
,
Italy
Class IIa
CE/MDR
IT349638
Withdrawn
Valid to Feb 2030
CE/MDR
IT353495
Active
Valid to Jun 2031
+1
authorizations
Kyphoset Bone Access Needle
Biopsybell SRL
·
,
Italy
Class IIa
CE/MDD
CE/MDR
IT349638
Withdrawn
Valid to Feb 2030
+1
authorizations
Aditus Kyphoplasty Drill
Biopsybell SRL
·
,
Italy
Class IIa
CE/MDR
IT349638
Withdrawn
Valid to Feb 2030
CE/MDR
IT353495
Active
Valid to Jun 2031
+1
authorizations
Cifopack Working Cannula And Trocar Tip
Biopsybell SRL
·
,
Italy
Class IIa
CE/MDR
IT349638
Withdrawn
Valid to Feb 2030
CE/MDR
IT353495
Active
Valid to Jun 2031
+2
authorizations
Vertemax Working Cannula And Bevel/Trocar Tip
Biopsybell SRL
·
,
Italy
Class IIa
CE/MDD
CE/MDR
IT349638
Withdrawn
Valid to Feb 2030
+2
authorizations
Cifopack Working Cannula And Expander
Biopsybell SRL
·
,
Italy
Class IIa
CE/MDR
IT349638
Withdrawn
Valid to Feb 2030
CE/MDR
IT353495
Active
Valid to Jun 2031
+1
authorizations
Kyphokit Working Cannula And Bevel Tip
Biopsybell SRL
·
,
Italy
Class IIa
CE/MDR
IT349638
Withdrawn
Valid to Feb 2030
CE/MDR
IT353495
Active
Valid to Jun 2031
+1
authorizations
Kyphokit Working Cannula And Bevel Tip
Biopsybell SRL
·
,
Italy
Class IIa
CE/MDR
IT349638
Withdrawn
Valid to Feb 2030
CE/MDR
IT353495
Active
Valid to Jun 2031
+1
authorizations
KYBS Kyphoplasty Balloon System
OK Medinet Korea Co., Ltd.
·
,
South Korea
Class IIa
CE/MDD
Renova Spine Kyphoplasty Working Cannula And Expander
Biopsybell SRL
·
,
Italy
Class IIa
CE/MDD
CE/MDR
IT349638
Withdrawn
Valid to Feb 2030
+1
authorizations
Aditus Fast Access System
Biopsybell SRL
·
,
Italy
Class IIa
CE/MDR
IT349638
Withdrawn
Valid to Feb 2030
CE/MDR
IT353495
Active
Valid to Jun 2031
Renova Spine Balloon Catheter
Biopsybell SRL
·
,
Italy
Class IIa
CE/MDD
CE/MDR
IT349638
Withdrawn
Valid to Feb 2030
+2
authorizations
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