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Implantable prosthetic and osteosynthesis devices
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Orthopaedic prostheses, osteosynthesis devices, devices for tendon and ligament synthesis
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Orthopaedic prostheses - various
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Orthopaedic cement preparation and application devices and kits
Orthopaedic cement preparation and application devices and kits
P099002
927 devices
Balloon Catheter
Hicren (Zhejiang) Medtech Co., Ltd.
·
,
China
Class IIa
CE/MDR
Puncture Needle
Shanghai Kinetic Medical Co., Ltd.
·
,
China
Class IIa
CE/MDR
GUDID
on market
Balloon
Dragon Crown Medical Co., Ltd.
·
,
China
Class IIa
CE/MDR
Balloon Catheter
Hicren (Zhejiang) Medtech Co., Ltd.
·
,
China
Class IIa
CE/MDR
FWS-007C(I) Guide Needle ϕ1.2×300
Chongqing FWS Medical Device Co., Ltd
·
,
China
Class IIa
CE/MDD
Medical Balloon Catheter Syringe Pump
Shanghai Kinetic Medical Co., Ltd.
·
,
China
Class I
CE/MDR
GUDID
on market
Balloon Catheter
Hicren (Zhejiang) Medtech Co., Ltd.
·
,
China
Class IIa
CE/MDR
Kaulmed
Bonegraft Biomaterials Co.
·
,
Türkiye
Class IIa
CE/MDD
Disp. Mixing Bowl-O
G-21 S.R.L.
·
,
Italy
Class I
CE/MDD
GUDID
on market
FWS-007C(I) Hollow Vertebral Drill ϕ3.0×190
Chongqing FWS Medical Device Co., Ltd
·
,
China
Class IIa
CE/MDD
Screwfix
Biopsybell SRL
·
,
Italy
Class IIa
CE/MDR
IT349638
Withdrawn
Valid to Feb 2030
CE/MDR
IT353495
Active
Valid to Jun 2031
+1
authorizations
FWS-007B(II) Hollow Vertebral Drill ϕ3.4×190
Chongqing FWS Medical Device Co., Ltd
·
,
China
Class IIa
CE/MDD
FWS-007C(I) Guide Needle ϕ1.5×300
Chongqing FWS Medical Device Co., Ltd
·
,
China
Class IIa
CE/MDD
Percutaneous Access Needle
Hicren (Zhejiang) Medtech Co., Ltd.
·
,
China
Class IIa
CE/MDR
FWS-007C(I) Dilation tube ϕ3.4×125
Chongqing FWS Medical Device Co., Ltd
·
,
China
Class IIa
CE/MDD
Bone Drill
Hicren (Zhejiang) Medtech Co., Ltd.
·
,
China
Class IIa
CE/MDR
SpaceFlex Shoulder Instrument Kit
G21 S.R.L.
·
,
Italy
Class I
FDA 510(k)
K202338
Active
Cleared 17 Feb 2021
CE/MDR
FWS-007C(I) Solid Vertebral Drill ϕ3.0×190
Chongqing FWS Medical Device Co., Ltd
·
,
China
Class IIa
CE/MDD
Bonetech
Bonegraft Biomaterials Co.
·
,
Türkiye
Class IIa
CE/MDD
Biongraft
Bonegraft Biomaterials Co.
·
,
Türkiye
Class IIa
CE/MDD
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