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Medical equipment and related accessories, software and consumables
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Instruments for functional explorations and therapeutic interventions
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General and multidisciplinary surgery instruments
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Surgical navigation instruments
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Surgical navigation instruments - software accessories
Surgical navigation instruments - software accessories
Z12011482
34 devices
Devices
Shoulder Planning App
Blue Ortho SAS
·
,
FR
Class IIa
CE/MDR
Microscope Navigation, 1.6
Brainlab SE
·
,
DE
Class IIb
CE/MDD
GUDID
on market
Microscope Navigation, 1.7
Brainlab SE
·
,
DE
Class IIb
CE/MDR
GUDID
on market
GPS Ankle - Navigation
Blue Ortho SAS
·
,
FR
Class IIa
CE/MDR
Ultrasound Navigation, 1.2
Brainlab SE
·
,
DE
Class IIb
CE/MDR
GUDID
on market
Mixed Reality Spine Navigation, 1.1
Brainlab SE
·
,
DE
Class IIb
CE/MDR
GUDID
on market
Automatic Registration, 2.5
Brainlab SE
·
,
DE
Class IIb
CE/MDD
GUDID
on market
EndoNaut Server Main Display SW
Therenva
·
,
FR
Class I
CE/MDR
ExactechGPS Total Ankle Case Manager Application
Blue Ortho SAS
·
,
FR
Class IIa
CE/MDR
Orthopilot
Aesculap AG
·
,
DE
Class IIa
CE/MDR
GPS Shoulder - Navigation
Blue Ortho SAS
·
,
FR
Class IIa
CE/MDR
GPS Knee - TKA Pro
Blue Ortho SAS
·
,
FR
Class IIa
CE/MDR
TKA Plus
Blue Ortho SAS
·
,
FR
Class IIa
CE/MDR
Mixed Reality Spine Navigation, 1.0
Brainlab SE
·
,
DE
Class IIb
CE/MDR
GUDID
on market
Micromate Navi+
iSYS Medizintechnik GmbH
·
,
AT
Class I
FDA 510(k)
K230130
Active
Cleared 10 Oct 2023
FDA 510(k)
K203720
Active
Cleared 22 Jun 2021
+1
authorizations
Alignment Software Spine, 2.1
Brainlab SE
·
,
DE
Class IIb
CE/MDR
GUDID
on market
Cranial IGS System Automatic Registration iMRI, 1.0
Brainlab SE
·
,
DE
Class IIb
CE/MDD
GUDID
on market
Automatic Registration, 2.6
Brainlab SE
·
,
DE
Class IIb
CE/MDR
GUDID
on market
TSA Navigation
Blue Ortho SAS
·
,
FR
Class IIa
CE/MDR
GPS Shoulder - Planning
Blue Ortho SAS
·
,
FR
Class IIa
CE/MDR
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