11 results
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40ms
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Sources: EU EUDAMED, US FDA
Filters
Country: Italy
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IMPLANTABLE PROSTHETIC DEVICES - OTHER
Device
EU MDR
·
Eu Md Class 2b
·Medicap S.r.l·On the market·7 countries
IMPLANTABLE PROSTHETIC DEVICES - OTHER
Device
EU MDD
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Eu Md Class 2b
·Medicap S.r.l·On the market·7 countries
IMPLANTABLE PROSTHETIC DEVICES - OTHER
Device
EU MDR
·
Eu Md Class 2b
·Medicap S.r.l·On the market·7 countries
Leone Orthodontic Implant TAD (Temporary Anchorage Device)
FDA 510(k)
FDA Class 2
·Dental
IMPLANTABLE DEVICES FOR JAW OSTHEOSYNTHESIS
Basic UDI-DI
EU MDR
·
Eu Md Class 2b
·B. & B. Dental S.r.l.·1 device
Active non-implantable imaging devices utilising ionizing radiation
Basic UDI-DI
EU MDR
·
Eu Md Class 2b
·I.M.D. GENERATORS S.R.L.·103 devices
SMR Shoulder/Spalla Trial Heads ECC .4 mm Adaptor, REF 9013.30.021; SMR Shoulder/Spalla Trial Heads ECC .8 mm Adaptor, REF 9013.30.031; for use in shoulder implant surgery.
FDA Enforcement
Class II
·Terminated·Limacorporate S.p.A·September 9, 2015
SMR Shoulder/Spalla Trial Humeral Head diameter .42 mm, REF 9013.22.425; SMR Shoulder/Spalla Trial Humeral Head diameter .44 mm, REF 9013.22.445; SMR Shoulder/Spalla Trial Humeral Head diameter .46 mm, REF 9013.22.465; for use in shoulder implant surgery.
FDA Enforcement
Class II
·Terminated·Limacorporate S.p.A·September 9, 2015
SMR TT Hybrid glenoid Std - Peg S, REF: 1379.59.210
FDA Enforcement
Class II
·Ongoing·Limacorporate S.p.A·April 5, 2023
Delta Cup Beater Positioner - Aligner, model # 9057.20.555 Used during implantation of the Delta Acetabular System
FDA Enforcement
Class II
·Completed·Limacorporate S.p.A·November 15, 2017
TEMA Elbow - Axle Small REF 1590.15.010 TEMA Elbow - Axle Large REF 1590.15.020 TEMA Elbow System is a cemented total elbow prosthesis.
FDA Enforcement
Class II
·Ongoing·Limacorporate S.p.A·January 1, 2025