30 results
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55ms
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Sources: EU EUDAMED, US FDA
ZND ENTERPRISES LLC
FDA registration
ZND ENTERPRISES LLC·1 product·🇺🇸 United States
DESIGN CONCEPTS AND ENTERPRISES, LLC
FDA registration
DESIGN CONCEPTS AND ENTERPRISES, LLC·1 product·🇺🇸 United States
Germ Terminator, Toothbrush Steam Sterilization for Oral Health. Model GT100. The Germ Terminator uses steam heat to sanitize two manual toothbrushes or two toothbrush heads. Water is poured into a reservoir in the device's housing. The steam cycle is followed by a drying cycle.
FDA Recall
Terminated
·Ceg Enterprises Llc·Product code MCF·April 5, 2016
EPIFLO; Transdermal continuous oxygen therapy device; single use; disposable medical device. Model Number EPIFLO-15. Mfr.By: Neogenix, LLC, dba Ogenix, 3401 Enterprise Pkwy, Suite 340, Beachwood, OH 44122. The EPIFLO System is intended to provide topical oxygen to treat 1.) skin ulcerations due to diabetes, venous stasis, post-surgical infections and gangrenous lesions 2.) Decubitus ulcers 3.) amputations/infected stumps 4.) skin grafts 5.) burns 6.) frostbite.
FDA Recall
Terminated
·Ogenix Corporation·Product code KPJ·April 16, 2012
Polmed.de Beata Rozwadowska
Authorized representative
🇩🇪 Germany·7 Manufacturers·1 Device
AFINA, spol.s r.o.
Authorized representative
🇨🇿 Czechia·8 Manufacturers·6 Devices
Maxcert Eurep
Authorized representative
🇩🇪 Germany·65 Manufacturers·8 Devices
Y. Sung Handelsvertretung
Authorized representative
🇩🇪 Germany·80 Manufacturers
Teleflex Medical
Importer
🇮🇪 Ireland·15 Manufacturers
MedEnvoy Global BV
Authorized representative
🇳🇱 Netherlands·143 Manufacturers·2306 Devices
Duomed France Endoscopie
Importer
🇫🇷 France·9 Manufacturers
QbD RepS BV
Authorized representative
🇧🇪 Belgium·86 Manufacturers·1555 Devices
SIR OFTALMICA SRL
Importer
🇮🇹 Italy·16 Manufacturers
MDSS GmbH
Authorized representative
🇩🇪 Germany·388 Manufacturers·16562 Devices
Emergo Europe B.V.
Authorized representative
🇳🇱 Netherlands·900 Manufacturers·22100 Devices
Gymna NV
Importer
🇧🇪 Belgium·20 Manufacturers
Duomed Belgium NV
Importer
🇧🇪 Belgium·62 Manufacturers
CMC Medical Devices & Drugs SL
Authorized representative
🇪🇸 Spain·698 Manufacturers·11260 Devices
Advena Limited
Authorized representative
🇲🇹 Malta·467 Manufacturers·13717 Devices
Obelis s.a.
Authorized representative
🇧🇪 Belgium·546 Manufacturers·18515 Devices