71 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Country: Italy
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MAY-GRÜNWALD
Device
EU IVDR
·
Eu Ivd Class A
·Pro-Eko Srl·On the market
May Grunwald Giemsa
Device
EU IVDR
·
Eu Ivd Class A
·Bio-Optica Milano S.p.A.·On the market·32 countries
May Grunwald Giemsa
Device
EU IVDR
·
Eu Ivd Class A
·Bio-Optica Milano S.p.A.·On the market·32 countries
May Grunwald Giemsa
Device
EU IVDR
·
Eu Ivd Class A
·Bio-Optica Milano S.p.A.·On the market·32 countries
May Grunwald Pappenheim
Device
EU IVDR
·
Eu Ivd Class A
·Bio-Optica Milano S.p.A.·On the market·32 countries
May Grunwald Pappenheim
Device
EU IVDR
·
Eu Ivd Class A
·Bio-Optica Milano S.p.A.·On the market·32 countries
May Grunwald Pappenheim
Device
EU IVDR
·
Eu Ivd Class A
·Bio-Optica Milano S.p.A.·On the market·32 countries
May Grünwald Pappenheim 500 ml
Device
EU IVDR
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Eu Ivd Class A
·Micras di Cipressi Gabriele·On the market·32 countries
May Grünwald Pappenheim 2500 ml
Device
EU IVDR
·
Eu Ivd Class A
·Micras di Cipressi Gabriele·On the market·32 countries
May Grünwald Pappenheim 1000 ml
Device
EU IVDR
·
Eu Ivd Class A
·Micras di Cipressi Gabriele·On the market·32 countries
May Grünwald Giemsa for smears 500 ml
Device
EU IVDR
·
Eu Ivd Class A
·Micras di Cipressi Gabriele·On the market·32 countries
May Grünwald Giemsa for tissue sections 100 test
Device
EU IVDR
·
Eu Ivd Class A
·Micras di Cipressi Gabriele·On the market·32 countries
DM SW - A FREE-STANDING, IMAGE PROCESSING DEVICE, IIA
Basic UDI-DI
EU MDR
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Eu Md Class 2a
·Esaote S.p.A.·1 device
MY FARMA NUTRITION S.R.L.
Authorized representative
🇮🇹 Italy·1 Manufacturer
TL-HEX TruLok Hexapod System, Double Row Footplates, TL-HEX Sterile, All Sizes: 120 MM, 140 MM, 160 MM, 180 MM, 200 MM. The TL-HEX TrueLock Hexapod System (TL-HEX) consists of rings, foot plates and struts to be used in conjunction with the TruLok external fixation system. The system is a metal bone fixation device for stabilization and correction during the normal healing process. The purpose of the TL-HEX System is to provide a solution for deformity correction and keeping the bone segments aligned during the healing process. The device may only be applied by a physician, who is fully responsible for the surgical and post-operative procedures of the system and is able to manage possible mechanical and software limitations. Indications for use for adults and all pediatric subgroups except newborns include: post-traumatic joint contracture which has resulted in loss of range of motion, fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction, open and closed fracture fixation, pseudoarthrosis of long bones, limb lengthening by epiphyseal or metaphyseal distraction, correction of bony or soft tissue deformities, correction of bony of soft tissue defects, joint arthrodesis, infected fractures or non unions.
FDA Enforcement
Class II
·Terminated·Orthofix Srl·June 13, 2018
MyLab Seven, Model 6400
FDA Enforcement
Class II
·Terminated·ESAOTE S.P.A.·October 31, 2018
MyLab Gamma, Model 7410
FDA Enforcement
Class II
·Terminated·ESAOTE S.P.A.·October 31, 2018
MyLab Alpha, Model 7400
FDA Enforcement
Class II
·Terminated·ESAOTE S.P.A.·October 31, 2018
PhenoMATRIX
FDA Enforcement
Class II
·Ongoing·Copan WASP·May 28, 2025
10 GAUGE DRILL, CODE INTVM-DRL
FDA Enforcement
Class II
·Terminated·BIOPSYBELL S.R.L.·May 26, 2021