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Results for “ATHENA”
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EUDAMED
344
FDA 510(k)
63
FDA PMA
GUDID
571
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European Union (all)
344
United States
634
More countries (12)
France
106
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84
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68
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28
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14
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12
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11
Austria
9
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6
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3
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2
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1
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Class I
437
Class IIa
2
Class IIb
1
Class III
8
Class II (US)
519
More classes (11)
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IVD General
IVD Annex II List A
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IVD for self-testing
Active implantable (AIMDD)
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978 devices found
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Device · Manufacturer · Authorizations
Verified
Status
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Registry
Class
Athena III Cervical Plate System APN24
Medyssey Co., Ltd.
·
,
FDA registration: South Korea
Class II
GUDID
on market
None
GUDID
II
Athena Cervical Plate System APK50
Medyssey Co., Ltd.
·
,
FDA registration: South Korea
Class II
GUDID
on market
None
GUDID
II
Athena, Shiny Black, Chameleon Lens, Freshwater, Red ATH006-CH-FW001
Rlvnt, Inc.
·
,
FDA registration: United States
Class I
GUDID
on market
None
GUDID
I
AtheNA Multi-Lyte® AIV Plus Test System A96101
Zeus Scientific, Inc.
·
,
United States
Not classified
GUDID
on market
None
GUDID
—
Athena Cervical Plate System APS4014L
Medyssey Co., Ltd.
·
,
FDA registration: South Korea
Class II
GUDID
on market
None
GUDID
II
Athena Cervical Plate System APS4513L
Medyssey Co., Ltd.
·
,
FDA registration: South Korea
Class II
GUDID
on market
None
GUDID
II
Athena III Cervical Plate System APQ80
Medyssey Co., Ltd.
·
,
FDA registration: South Korea
Class II
GUDID
on market
None
GUDID
II
Athena III Cervical Plate System APO53
Medyssey Co., Ltd.
·
,
FDA registration: South Korea
Class II
GUDID
on market
None
GUDID
II
Athena III Cervical Plate System APS3511WWS
Medyssey Co., Ltd.
·
,
FDA registration: South Korea
Class II
GUDID
on market
None
GUDID
II
Athena, Tortoise Blue, Chameleon Lens, Hardwater, Bronze ATH010-CH-HW006
Rlvnt, Inc.
·
,
FDA registration: United States
Class I
GUDID
on market
None
GUDID
I
Athena III Cervical Plate System APS3512WWS
Medyssey Co., Ltd.
·
,
FDA registration: South Korea
Class II
GUDID
on market
None
GUDID
II
Athena Champion AC5000-4S
Young Dental Manufacturing I, LLC
·
,
United States
Class I
GUDID
on market
None
GUDID
I
Athena Cervical Plate System APG74
Medyssey Co., Ltd.
·
,
FDA registration: South Korea
Class II
GUDID
on market
None
GUDID
II
Athena, Tortoise Rose, Brown Lens, Freshwater, Sunfire ATH011-BR-FW007
Rlvnt, Inc.
·
,
FDA registration: United States
Class I
GUDID
on market
None
GUDID
I
Athena Cervical Plate System APS4010L
Medyssey Co., Ltd.
·
,
FDA registration: South Korea
Class II
GUDID
on market
None
GUDID
II
Athena III Cervical Plate System APP74
Medyssey Co., Ltd.
·
,
FDA registration: South Korea
Class II
GUDID
on market
None
GUDID
II
Athena II Cervical Plate System APW74
Medyssey Co., Ltd.
·
,
FDA registration: South Korea
Class II
GUDID
not on market
Withdrawn
GUDID
II
Athena, Shiny Black, Grey Lens, Hardwater, Bronze ATH006-GY-HW006
Rlvnt, Inc.
·
,
FDA registration: United States
Class I
GUDID
on market
None
GUDID
I
Athena, Shiny Black, Grey Lens, Freshwater, Smoke ATH006-GR-HW008
Rlvnt, Inc.
·
,
FDA registration: United States
Class I
GUDID
on market
None
GUDID
I
Athena Cervical Plate System APJ30
Medyssey Co., Ltd.
·
,
FDA registration: South Korea
Class II
GUDID
on market
None
GUDID
II
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