30 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Country: Germany
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TSM knee brace PRO with patellar cut-out
Device
EU MDR
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Eu Md Class 1
·AET Australasian European Trading GmbH·On the market
TSM knee support with double hinge stays, no patella cut-out
Device
EU MDR
·
Eu Md Class 1
·AET Australasian European Trading GmbH·On the market
TSM knee brace PRO with patellar cut-out and TT insert
Device
EU MDR
·
Eu Md Class 1
·AET Australasian European Trading GmbH·On the market
TSM knee brace with patellar cut-out, steel spring and TT insert
Device
EU MDR
·
Eu Md Class 1
·AET Australasian European Trading GmbH·On the market
ABUTMENT RP, ABUTMENT WP, BURN-OUT COPING, SCREWS, TITANIUM ADHESIVE BASE, ALLIGATOR ABUTMENT, SOLID ABUTMENT, RETENTIVE
FDA 510(k)
FDA Class 2
·Dental
TSM knee support with double-hinge, light metal stays and patellar cut-out
Device
EU MDR
·
Eu Md Class 1
·AET Australasian European Trading GmbH·On the market·2 countries
TSM knee support active, open with pattelar cut-out and POM double hinge stays
Device
EU MDR
·
Eu Md Class 1
·AET Australasian European Trading GmbH·On the market·2 countries
TSM knee support with patellar cut-out, patellar tendon strap and AET double-hinge,light metal stay
Device
EU MDR
·
Eu Md Class 1
·AET Australasian European Trading GmbH·On the market
Alinity i Processing Module, 03R65 01, with the below components. a. TED (Thermo Electric Device) Engine, Reagent cooler; b. CABLE, POWER OUT, TED CNTRLER Product Usage: The Alinity i processing module is a fully automated immunoassay analyzer allowing random and continuous access, as well as priority and automated retest processing using chemiluminescent microparticle immunoassay (CMIA) technology. CMIA technology is used to determine the presence of antigens, antibodies, and analytes in samples.
FDA Enforcement
Class II
·Terminated·Abbott Gmbh & Co. KG·June 5, 2019
Aquilex Fluid Control System-Intended to provide fluid distension of the uterus during diagnostic and operative hysteroscopies and to monitor the volume differential between the irrigation fluid flowing into and out of the uterus. Models AQL-100PBS and AQL-100P
FDA Enforcement
Class II
·Ongoing·WOM World Of Medicine AG·October 4, 2023
Grandio SO Heavy Flow Caps, Color A3 - Product Usage: Filling minimally invasive cavities of all classes - Filling small class I cavities and extended fissure sealing - Filling class II - V cavities including V-shaped defects and cervical caries - Blocking out undercuts - Lining or coating cavities - Repairing fillings and veneers - Luting translucent prosthetic pieces (e.g., full ceramic crowns, etc.).
FDA Enforcement
Class II
·Terminated·Voco GmbH·October 9, 2019
Link OptiStem Rasp Handle-Used with the OptiStem Rasp to prepare the femoral medullary canal for a knee prosthesis implant during a total knee arthroplasty surgical procedure Item Number: 17-5220/01
FDA Enforcement
Class II
·Ongoing·Waldemar Link GmbH & Co. KG (Mfg Site)·September 6, 2023
B.R.A.H.M.S PlGF Plus KRYPTOR, Catalog Number: 859075N. in vitro diagnostic test for Placental Growth Factor
FDA Enforcement
Class II
·Ongoing·Brahms GmbH·April 15, 2026
Alinity i Processing Module, (a) Part Number 03R65-01 (b) Part Number A-30108552-01 (c) Part Number A-30109694-01 Product Usage: The Alinity i processing module is a fully automated immunoassay analyzer allowing random and continuous access, as well as priority and automated retest processing using chemiluminescent microparticle immunoassay (CMIA) technology. CMIA technology is used to determine the presence of antigens, antibodies, and analytes in samples.
FDA Enforcement
Class II
·Terminated·Abbott Gmbh & Co. KG·February 6, 2019
exoplan version 3.1 Rijeka Software -A medical software, intended to support the pre-operative planning of dental implants using the visualization of the implant placement within images of the patents anatomy.
FDA Enforcement
Class II
·Ongoing·Exocad GmbH·October 4, 2023
Dr. Fenyves und Gut Deutschland GmbH
Manufacturer
🇩🇪 Germany·1 Basic UDI-DI·1 Device·MDC MEDICAL DEVICE CERTIFICATION GMBH
Sonata Patient Recorder
Device
EU MDD
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Eu Md Class 2a
·Dr. Fenyves und Gut Deutschland GmbH·On the market·10 countries
Sonata Patient Recorder
Basic UDI-DI
EU MDD
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Eu Md Class 2a
·Dr. Fenyves und Gut Deutschland GmbH·1 device
Cutting Forceps
Basic UDI-DI
EU MDD
·
Eu Md Class 1
·Heinz Kurz GmbH·1 device
OMT GmbH & Co. KG
Importer
🇩🇪 Germany