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Medical equipment and related accessories, software and consumables
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Instruments for functional explorations and therapeutic interventions
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General and multidisciplinary surgery instruments
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Electrosurgical instruments
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Electrosurgery instruments - other
Electrosurgery instruments - other
Z12010999
39 devices
Devices
Plasmage
Brera Medical Technologies S.r.l.
·
,
IT
Class IIb
CE/MDD
Iberis
Shanghai AngioCare Medical Technology Co., Ltd.
·
,
CN
Class IIb
CE/MDD
Megadyne
Megadyne Medical Products, Inc.
·
,
US
Class IIb
CE/MDD
GUDID
on market
Plasmage System
Brera Medical Technologies S.r.l.
·
,
IT
Class IIb
CE/MDD
Megadyne
Megadyne Medical Products, Inc.
·
,
US
Class IIb
CE/MDD
GUDID
on market
Megadyne
Megadyne Medical Products, Inc.
·
,
US
Class IIb
CE/MDD
GUDID
on market
Electrosurgical Tip Cleaner
Deroyal Industries, Inc.
·
,
US
Class I
CE/MDR
GUDID
on market
Megadyne
Megadyne Medical Products, Inc.
·
,
US
Class IIb
CE/MDD
GUDID
on market
truSculpt 40 HH
Cutera, Inc.
·
,
US
Class IIb
CE/MDD
GUDID
on market
Handy
Led SpA
·
,
IT
Class IIb
CE/MDR
Electrosurgical Tip Cleaner
Deroyal Industries, Inc.
·
,
US
Class I
CE/MDD
GUDID
on market
truSculpt 40 HF
Cutera, Inc.
·
,
US
Class IIb
FDA 510(k)
K133739
Active
Cleared 5 Sep 2014
FDA 510(k)
K162512
Active
Cleared 9 Dec 2016
+4
authorizations
Megadyne
Megadyne Medical Products, Inc.
·
,
US
Class IIb
CE/MDD
GUDID
on market
truSculpt 16
Cutera, Inc.
·
,
US
Class IIb
CE/MDD
GUDID
on market
Megadyne
Megadyne Medical Products, Inc.
·
,
US
Class IIb
CE/MDD
GUDID
on market
High frequency electrosurgical equipment
Wuxi Beien Surgery Device Co., Ltd.
·
,
CN
Class IIb
CE/MDR
Cathay
Cathay Manufacturing Corp.
·
,
CN
Class I
CE/MDR
ITL EssentialsTM Quiver with PVC Loop
Itl Asia Pacific Sdn. Bhd.
·
,
MY
Class I
CE/MDR
GUDID
on market
Electrosurgical Tip Cleaner
Deroyal Industries, Inc.
·
,
US
Class I
CE/MDD
GUDID
on market
Blayco
Cathay Manufacturing Corp.
·
,
CN
Class I
CE/MDR
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