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Results for “Safire™”
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EUDAMED
2
FDA 510(k)
4
FDA PMA
1
GUDID
40
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2
United States
45
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2
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2
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40
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5
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47 devices found
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Class
Safire™ TX 402842
Irvine Biomedical, Inc.
·
,
FDA registration: United States
Class III
GUDID
on market
None
GUDID
III
Safire™ Blu™ SP A402871
Irvine Biomedical, Inc.
·
,
FDA registration: United States
Class III
GUDID
not on market
Withdrawn
GUDID
III
Bransist Safire
Open recall
Shimadzu Corp.
·
,
FDA registration: United States
Class II
FDA 510(k)
K062360
Active
Cleared 5 Oct 2006
Active
510(k)
510(k)
II
Digital Angiography System Digitex Safire
Shimadzu Corp.
·
,
FDA registration: United States
Class II
FDA 510(k)
K032443
Active
Cleared 20 Feb 2004
Active
510(k)
510(k)
II
Safire
Siemens Medical Solutions Usa, Inc.
·
,
United States
Class II
FDA 510(k)
K103424
Active
Cleared 22 Nov 2011
Active
510(k)
510(k)
II
Digital Radiography System Radspeed Safire
Shimadzu Corp.
·
,
FDA registration: United States
Class II
FDA 510(k)
K050925
Active
Cleared 1 Jun 2005
Active
510(k)
510(k)
II
Safire™ TX Ablation Catheter, Safire™ TX, Catheter Extension Cable, Therapy™ Dual-8™ Ablation Catheter, Cables 16- 17- 1
Irvine Biomedical, Inc.(Ibi)
·
,
United States
(FDA 510(k) applicant)
Class III
FDA PMA
P040042
Active
Approved 18 Nov 2005
Active
PMA
PMA
III
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