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Devices for general and specialist dressings
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Special dressings
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Haemostatic dressings
/
Inorganic haemostatic devices
Inorganic haemostatic devices
M040504
54 devices
Devices
Astringedent X
Ultradent Products, Inc.
·
,
US
Class IIa
CE/MDR
StatSeal
Biolife, LLC
·
,
US
Class IIa
CE/MDD
GUDID
on market
ViscoStat Clear
Ultradent Products, Inc.
·
,
US
Class IIa
CE/MDR
Willocell
Will-Pharma BV
·
,
NL
Class III
CE/MDD
Willocell
Will-Pharma BV
·
,
NL
Class III
CE/MDD
EndoClot®
EndoClot Plus Co., Ltd.
·
,
CN
Class IIa
CE/MDD
EndoClot®
EndoClot Plus Co., Ltd.
·
,
CN
Class IIa
FDA 510(k)
K190677
Active
Cleared 29 Jan 2021
FDA 510(k)
K191254
Active
Cleared 30 Jan 2020
+2
authorizations
Willocell
Will-Pharma BV
·
,
NL
Class III
CE/MDD
Astringedent
Ultradent Products, Inc.
·
,
US
Class IIa
CE/MDR
StatSeal
Biolife, LLC
·
,
US
Class IIa
CE/MDD
GUDID
on market
StatSeal (EN)
Biolife, LLC
·
,
US
Class IIa
CE/MDR
Willocell
Will-Pharma BV
·
,
NL
Class III
CE/MDD
Tourniquet
Shenzhen TMI Medical Supplies Co., ltd
·
,
CN
Class I
CE/MDR
StatSeal
Biolife, LLC
·
,
US
Class IIa
CE/MDD
GUDID
on market
Willocell
Will-Pharma BV
·
,
NL
Class III
CE/MDD
StatSeal
Biolife, LLC
·
,
US
Class IIa
CE/MDD
GUDID
on market
EndoClot®
EndoClot Plus Co., Ltd.
·
,
CN
Class IIa
CE/MDD
ViscoStat
Ultradent Products, Inc.
·
,
US
Class IIa
CE/MDR
ViscoStat
Ultradent Products, Inc.
·
,
US
Class IIa
CE/MDR
EndoClot®
EndoClot Plus Co., Ltd.
·
,
CN
Class IIa
CE/MDD
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