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Results for “HP GEL”
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EUDAMED
65
FDA 510(k)
4
FDA PMA
GUDID
173
Country / market
European Union (all)
51
United States
177
More countries (5)
Germany
39
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12
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12
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1
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1
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Class I
13
Class IIa
14
Class IIb
37
Class III
161
Class II (US)
4
More classes (11)
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IVD General
1
IVD Annex II List A
IVD Annex II List B
IVD for self-testing
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230 devices found
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Device · Manufacturer · Authorizations
Verified
Status
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Registry
Class
SIENTRA Silicone Gel Breast Implant 10621-190HP
Sientra, Inc.
·
,
United States
(FDA 510(k) applicant)
Class III
GUDID
on market
None
GUDID
III
SIENTRA Silicone Gel Breast Implant 20721-650HP
Sientra, Inc.
·
,
United States
(FDA 510(k) applicant)
Class III
GUDID
on market
None
GUDID
III
SIENTRA Silicone Gel Breast Implant 20645-180HP
Sientra, Inc.
·
,
United States
(FDA 510(k) applicant)
Class III
GUDID
not on market
Withdrawn
GUDID
III
SIENTRA Silicone Gel Breast Implant 20645-550HP
Sientra, Inc.
·
,
United States
(FDA 510(k) applicant)
Class III
GUDID
not on market
Withdrawn
GUDID
III
SIENTRA Silicone Gel Breast Implant 20721-190HP
Sientra, Inc.
·
,
United States
(FDA 510(k) applicant)
Class III
GUDID
on market
None
GUDID
III
SIENTRA Silicone Gel Breast Implant 10721-440HP
Sientra, Inc.
·
,
United States
(FDA 510(k) applicant)
Class III
GUDID
on market
None
GUDID
III
SIENTRA Silicone Gel Breast Implant 10621-620HP
Sientra, Inc.
·
,
United States
(FDA 510(k) applicant)
Class III
GUDID
on market
None
GUDID
III
SIENTRA Silicone Gel Breast Implant 10521-335HP
Sientra, Inc.
·
,
United States
(FDA 510(k) applicant)
Class III
GUDID
not on market
Withdrawn
GUDID
III
SIENTRA Silicone Gel Breast Implant 10621-535HP
Sientra, Inc.
·
,
United States
(FDA 510(k) applicant)
Class III
GUDID
on market
None
GUDID
III
SIENTRA Silicone Gel Breast Implant 20721-440HP
Sientra, Inc.
·
,
United States
(FDA 510(k) applicant)
Class III
GUDID
on market
None
GUDID
III
SIENTRA Silicone Gel Breast Implant 20676-365HP
Sientra, Inc.
·
,
United States
(FDA 510(k) applicant)
Class III
GUDID
not on market
Withdrawn
GUDID
III
SIENTRA Silicone Gel Breast Implant 20676-390HP
Sientra, Inc.
·
,
United States
(FDA 510(k) applicant)
Class III
GUDID
not on market
Withdrawn
GUDID
III
SIENTRA Silicone Gel Breast Implant 10621-590HP
Sientra, Inc.
·
,
United States
(FDA 510(k) applicant)
Class III
GUDID
on market
None
GUDID
III
SIENTRA Silicone Gel Breast Implant 10621-415HP
Sientra, Inc.
·
,
United States
(FDA 510(k) applicant)
Class III
GUDID
on market
None
GUDID
III
SIENTRA Silicone Gel Breast Implant 20621-240HP
Sientra, Inc.
·
,
United States
(FDA 510(k) applicant)
Class III
GUDID
on market
None
GUDID
III
SIENTRA Silicone Gel Breast Implant 20621-280HP
Sientra, Inc.
·
,
United States
(FDA 510(k) applicant)
Class III
GUDID
on market
None
GUDID
III
SJM™ Masters Series HP Gelweave Valsalva 19VAVGJ-515
St. Jude Medical, Inc.
·
,
United States
(FDA 510(k) applicant)
Class III
GUDID
on market
None
GUDID
III
SIENTRA Silicone Gel Breast Implant 20676-190HP
Sientra, Inc.
·
,
United States
(FDA 510(k) applicant)
Class III
GUDID
not on market
Withdrawn
GUDID
III
SIENTRA Silicone Gel Breast Implant 20646-295HP
Sientra, Inc.
·
,
United States
(FDA 510(k) applicant)
Class III
GUDID
on market
None
GUDID
III
SJM™ Masters Series HP Gelweave Valsalva 25VAVGJ-515
St. Jude Medical, Inc.
·
,
United States
(FDA 510(k) applicant)
Class III
GUDID
on market
None
GUDID
III
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