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Endotherapy and electrosurgical devices
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Endotherapy devices
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Spinal endotherapy devices
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Spinal percutaneous plastic devices with balloon
Spinal percutaneous plastic devices with balloon
K010301
301 devices
Renova Spine Balloon Catheter
Biopsybell SRL
·
,
Italy
Class IIa
CE/MDD
CE/MDR
IT349638
Withdrawn
Valid to Feb 2030
+2
authorizations
Renova Spine Kyphoplasty 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Withdrawn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
+2
authorizations
Renova Spine Kyphoplasty 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Withdrawn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
Cifopack Balloon Catheter
Biopsybell SRL
·
,
Italy
Class IIa
CE/MDR
IT349638
Withdrawn
Valid to Feb 2030
CE/MDR
IT353495
Active
Valid to Jun 2031
+1
authorizations
Kyphokit 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Withdrawn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 Balloon Catheter
Biopsybell SRL
·
,
Italy
Class IIa
CE/MDR
IT349638
Withdrawn
Valid to Feb 2030
CE/MDR
IT353495
Active
Valid to Jun 2031
Cifopack Balloon Catheter
Biopsybell SRL
·
,
Italy
Class IIa
CE/MDR
IT349638
Withdrawn
Valid to Feb 2030
CE/MDR
IT353495
Active
Valid to Jun 2031
+1
authorizations
Renova Spine Kyphoplasty Working Cannula And Bevel/Trocar Tip
Biopsybell SRL
·
,
Italy
Class IIa
CE/MDD
CE/MDR
IT349638
Withdrawn
Valid to Feb 2030
+2
authorizations
Aditus Kyphoplasty 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Withdrawn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
Renova Spine Fast Access System
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Withdrawn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Withdrawn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
Renova Spine Classic Access System
Biopsybell SRL
·
,
Italy
Class IIa
CE/MDR
IT349638
Withdrawn
Valid to Feb 2030
CE/MDR
IT353495
Active
Valid to Jun 2031
+2
authorizations
Kyphoset Drill
Biopsybell SRL
·
,
Italy
Class IIa
CE/MDD
CE/MDR
IT349638
Withdrawn
Valid to Feb 2030
+1
authorizations
Rti-K
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
IT353495
Active
Valid to Jun 2031
CE/MDR
IT349638
Withdrawn
Valid to Feb 2030
+1
authorizations
Aditus Kyphoplasty 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
Osteopearl
Biopsybell SRL
·
,
Italy
Class IIa
CE/MDD
CE/MDR
IT349638
Withdrawn
Valid to Feb 2030
+2
authorizations
Renova Spine Kyphoplasty Drill
Biopsybell SRL
·
,
Italy
Class IIa
CE/MDR
IT349638
Withdrawn
Valid to Feb 2030
CE/MDR
IT353495
Active
Valid to Jun 2031
+2
authorizations
Kyphokit Kirschner Guide
Biopsybell SRL
·
,
Italy
Class IIa
CE/MDR
IT349638
Withdrawn
Valid to Feb 2030
CE/MDR
IT353495
Active
Valid to Jun 2031
+2
authorizations
Synflate Vertebral Balloon Small Medium Large
Synthes GmbH
·
,
Switzerland
Class IIa
CE/MDR
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