EUDAMED

May 22, 2023

EUDAMED is the IT system established by Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnosis medical devices. EUDAMED is integral part of the implementation of the two Medical Devices Regulations.

source: European Commission

Latest News

First-in-human prediction of chronic pain state using intracranial neural biomarkers

May 22, 2023Chronic pain syndromes are often refractory to treatment and cause substantial suffering and disability. Pain severity is often measured through subjective report, while objective biomarkers that may guide diagnosis and treatment are lacking. Four individuals with refractory neuropathic pain were implanted with chronic intracranial electrodes in the anterior cingulate cortex and orbitofrontal cortex (OFC). We successfully predicted intraindividual chronic pain severity scores from neural activity with high sensitivity using machine learning methods. Author(s) Source Shirvalkar P, Prosky J, Chin G et al. nature neuroscience 22.05.2023 This is a post of a scientific or business information. The information given here is checked thoroughly by “Implant-Register”. However we can´t be responsible for the content. The content usually is shortened to make it understandable for many. Read the linked original text if you are interested. Contact the publisher, if you have questions. You may inform us about changes of the information to improve the Register. Comments: n/alet us know [...] Read more...

German implant registry goes into trial operation

May 17, 2023The Implant Registry Germany has received the first data on breast implants from hospitals. This marks the start of trial operation, the Federal Ministry of Health (BMG) announced today. Technically, the register has been operational since March 31 of this year. The registry will deal with breast implants, as well as hip and knee endoprostheses. For breast implants, mandatory reporting is planned for January 1, 2024. Author(s) Source may/EB/aerzteblatt.de aerzteblatt.de 17.05.2023 (german text) This is a post of a scientific or business information. The information given here is checked thoroughly by “Implant-Register”. However we can´t be responsible for the content. The content usually is shortened to make it understandable for many. Read the linked original text if you are interested. Contact the publisher, if you have questions. You may inform us about changes of the information to improve the Register. Comments: n/alet us know [...] Read more...

High-power chargers for electric vehicles are safe for patients with pacemakers and defibrillators

April 17, 2023Battery electric vehicle (BEV) sales and use are rapidly expanding. Battery electric vehicles, along with their charging stations, are a potential source of electromagnetic interference (EMI) for patients with cardiac implantable electronic devices (CIEDs). The new ‘high-power’ charging stations have the potential to create strong electromagnetic fields and induce EMI in CIEDs, and their safety has not been evaluated. Conclusions The use of electric cars with high-power chargers by patients with cardiac devices appears to be safe with no evidence of clinically relevant EMI. Reasonable caution, by minimizing the time spent in close proximity with the charging cables, is still advised as the occurrence of very rare events cannot be excluded from our results. Author(s) Source Lennerz C, Schaarschmidt C, Blazek P et al. EP Europace, euad042, https://doi.org/10.1093/europace/euad042 This is a post of a scientific or business information. The information given here is checked thoroughly by “Implant-Register”. However we can´t be responsible for the content. The content usually is shortened to make it understandable for many. Read the linked original text if you are interested. Contact the publisher, if you have questions. You may inform us about changes of the information to improve the Register. Comments: n/alet us know [...] Read more...

One-day functional rehabilitation with Zygoma implants

March 28, 2023Treatment with Zygoma implants is a treatment option for edentulous patients in the maxilla to obtain a fixed prosthesis with implants within one day and even with very little jaw bone. Case report with pictures. Author(s) Source Kraus D Dentale Implantologie & Parodontologie 28.03.2023 (german) This is a post of a scientific or business information. The information given here is checked thoroughly by “Implant-Register”. However we can´t be responsible for the content. The content usually is shortened to make it understandable for many. Read the linked original text if you are interested. Contact the publisher, if you have questions. You may inform us about changes of the information to improve the Register. Comments: n/alet us know [...] Read more...

New Companies

QT Vascular Ltd.

April 10, 2023unregisteredregister now IMPLANTS U.S.A. product group cardiovascular implants products Chocolate® PTA Balloon Catherer PTCA Balloon Catheter Chocolate Touch® PTA Balloon Catheter Glider™ PTCA Balloon Catheter GliderfleX® PTA Balloon Catheter GliderXtreme™ PTA Balloon Catheter contact n/a This is a post of a nonregistered company. Information given here is checked thoroughly by “Implant-Register”. However we can not guarantee for any material, property or completeness. Products may not be available in all countries. Ask the company for such questions and give us the information to improve the Register. If there are pictures like logos or implants, they may be taken from the companies website. The publishing company may inform us to improve or hide them. [...] Read more...

ChoiceSpine™

April 5, 2023unregisteredregister now IMPLANTS U.S.A. product group general implants – bone (for use in spine) products CERVICAL CHIPS DBM 100 FIBER PUTTY MEMBRANE SPONGE STRATOFUSE LUMBAR STRIP product group skeletal system implants – spine products cervical AMBASSADOR® BLACKBIRD™ BLACKBIRD™ HLS BOOMERANG™ FALCON™ GIBRALT® TOMCAT™ thoracolumbar LANCER™ PROLIANT® RAVEN™ RAVEN™ LATERAL THUNDERBOLT™ TYPHOON™ interbody ASCENDANT® BLACKHAWK™ TI HARPOON™ HARRIER™ HARRIER™ SA OCTANE® SABRE™ SHARK™ STEALTH™ TIGERSHARK™ TIGERSHARK™ C TIGERSHARK™ L TIGERSHARK™ TL VEO® SI fixation TRITON lateral RAVEN™ LATERAL vertebral body replacement HAWKEYE™ TI contact n/a This is a post of a nonregistered company. Information given here is checked thoroughly by “Implant-Register”. However we can not guarantee for any material, property or completeness. Products may not be available in all countries. Ask the company for such questions and give us the information to improve the Register. If there are pictures like logos or implants, they may be taken from the companies website. The publishing company may inform us to improve or hide them. [...] Read more...

IVORYGraft

April 4, 2023unregisteredregister now IMPLANTS ISRAEL product group dental implant: bone substitute products Ivory Dentin Graft™ glass vial syringe contact n/a This is a post of a nonregistered company. Information given here is checked thoroughly by “Implant-Register”. However we can not guarantee for any material, property or completeness. Products may not be available in all countries. Ask the company for such questions and give us the information to improve the Register. If there are pictures like logos or implants, they may be taken from the companies website. The publishing company may inform us to improve or hide them. [...] Read more...

New Implants

Sientra saline sizer

May 13, 2023saline sizers (discontinued) products round moderate plus projection smooth surface high projection smooth surface teardrop shape, classic base moderate plus projection smooth surface teardrop shape, round base high projection smooth surface [...] Read more...

Sientra breast tissue expanders

May 13, 2023breast tissue expanders products AlloX² mid height smooth and textured surface, integrated port full height smooth and textured surface, integrated port DERMASPAN™ mid height smooth and textured surface, integrated port full height smooth and textured surface, integrated port mid height textured surface, remote port full height textured surface, remote port [...] Read more...

Silimed BioDesign Line

May 3, 2023IMPLANT PROFILE unregisteredregister here the implant (maximum type) 01 indication implant, compensation of breast deficit 02 specific the implant offers the plastic surgeon the possibility of choosing the silicone implant according to the biotype of the patient 5 types: advance, maximum, natural, enhance, nuance 03 contraindication(s) ◊◊◊◊◊ 04 implant description ◊◊◊◊◊ 05 specific attributes ◊◊◊◊◊ 06 material filling gel: high strength cohesive silicon gel (HSC+) 07 implant surface 1. pure polyurethane 2. true texture 08 key literature ◊◊◊◊◊ 09 notes about the company Silimed Industria de Implantes Ltda 10 approvals ANVISA CE-marking ISO 13485 learn more about approvals, certifications, authorities No comments yet. You are welcome to send comments or experiences.HERE, if you received this implant. and HERE, if you placed this implant. Received this implant? You can register it HERE (fee).Placed this implant? You can register it HERE for your patient (fee). current as of 2023-05-04 unregistered / this page is not approved by the provider / unregistered implants have no professionnal lines or advertising This “Implant Profile” shows a non-registered implant. This is a most comprehensive description of the important parameters of an implant. Information given here are checked thoroughly by “Implant-Register” and is not approved by the manufacturer/the company. Illustrations refer to the company, if not shown differently. However we can not guarantee for any material or properties. Implants may not be available in all countries. If there are pictures like logos or implants, they are taken from the companies website. The publishing company may inform us to hide them. [...] Read more...

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