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Results for “GALILEO”
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EUDAMED
70
FDA 510(k)
34
FDA PMA
1
GUDID
148
Country / market
European Union (all)
68
United States
183
More countries (5)
Germany
57
Italy
6
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3
Greece
1
France
1
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Class I
25
Class IIa
28
Class IIb
3
Class III
1
Class II (US)
166
More classes (11)
Class A
7
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4
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14
IVD General
IVD Annex II List A
2
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IVD for self-testing
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250 devices found
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Status
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Class
GALILEO® TROCHANTERIC NAIL, LEFT, Ø10mm x 36cm x 125° 1020-360
Advanced Orthopaedic Solutions, Inc.
·
,
FDA registration: United States
Class II
GUDID
not on market
Withdrawn
GUDID
II
GALILEO® LEFTY TIGHTY™ CRT²™ LAG SCREW, LEFT, 10.5mm x 100mm 1192-100
Advanced Orthopaedic Solutions, Inc.
·
,
FDA registration: United States
Class II
GUDID
not on market
Withdrawn
GUDID
II
GALILEO® TROCHANTERIC NAIL, RIGHT, Ø10mm x 45cm x 125° 1021-450
Advanced Orthopaedic Solutions, Inc.
·
,
FDA registration: United States
Class II
GUDID
not on market
Withdrawn
GUDID
II
AOS Capturing Rod, Galileo Lag screw 0455
Advanced Orthopaedic Solutions, Inc.
·
,
FDA registration: United States
Class I
GUDID
on market
None
GUDID
I
Galileo Colposcope, Direct Access 430LVCDA-T
Gynex Corporation
·
,
United States
(FDA 510(k) applicant)
Class II
GUDID
on market
None
GUDID
II
Locking Tool, Galileo® Lag Screw 0456-100
Advanced Orthopaedic Solutions, Inc.
·
,
FDA registration: United States
Class II
GUDID
not on market
Withdrawn
GUDID
II
GALILEO® TROCHANTERIC NAIL, LEFT, Ø10mm x 33cm x 125° 1020-330
Advanced Orthopaedic Solutions, Inc.
·
,
FDA registration: United States
Class II
GUDID
not on market
Withdrawn
GUDID
II
GALILEO™ LAG SCREW, RIGHT, 10.5mm x 100mm 1099-100
Advanced Orthopaedic Solutions, Inc.
·
,
FDA registration: United States
Class II
GUDID
not on market
Withdrawn
GUDID
II
GALILEO® TROCHANTERIC NAIL, LEFT, Ø11mm x 33cm x 125° 1022-330
Advanced Orthopaedic Solutions, Inc.
·
,
FDA registration: United States
Class II
GUDID
not on market
Withdrawn
GUDID
II
Galileo Colposcope, Direct Access 430VCDA-T
Gynex Corporation
·
,
United States
(FDA 510(k) applicant)
Class II
GUDID
on market
None
GUDID
II
Galileo Removal Tool 0856-100
Advanced Orthopaedic Solutions, Inc.
·
,
FDA registration: United States
Class II
GUDID
not on market
Withdrawn
GUDID
II
Galileo Colposcope, Direct Access 200DA-T
Gynex Corporation
·
,
United States
(FDA 510(k) applicant)
Class II
GUDID
on market
None
GUDID
II
Galileo Extraction Tool, Capturing Rod Nut 0858-200
Advanced Orthopaedic Solutions, Inc.
·
,
FDA registration: United States
Class II
GUDID
not on market
Withdrawn
GUDID
II
Galileo® Locking Tool 5031-000
Advanced Orthopaedic Solutions, Inc.
·
,
FDA registration: United States
Class II
GUDID
not on market
Withdrawn
GUDID
II
GALILEO® CRT²™ LAG SCREW, RIGHT, 10.5mm x 95mm 1092-095
Advanced Orthopaedic Solutions, Inc.
·
,
FDA registration: United States
Class II
GUDID
not on market
Withdrawn
GUDID
II
GALILEO™ LAG SCREW, RIGHT, 10.5mm x 95mm 1099-095
Advanced Orthopaedic Solutions, Inc.
·
,
FDA registration: United States
Class II
GUDID
not on market
Withdrawn
GUDID
II
GALILEO® LEFTY TIGHTY™ CRT²™ LAG SCREW, LEFT, 10.5mm x 120mm 1192-120
Advanced Orthopaedic Solutions, Inc.
·
,
FDA registration: United States
Class II
GUDID
not on market
Withdrawn
GUDID
II
Galileo Echo 0087000
Immucor, Inc.
·
,
United States
Class II
CE/IVDR
GUDID
on market
Active
CE IVDR
GUDID
II
VESALIUS Galileo bipolar scissors L=140mm
Telea Electronic Engeenering SRL
·
,
FDA registration: United States
Class II
GUDID
on market
None
GUDID
II
Galileo® Lag Screw Inserter 0454-100
Advanced Orthopaedic Solutions, Inc.
·
,
FDA registration: United States
Class II
GUDID
not on market
Withdrawn
GUDID
II
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