30 results · 55ms · Sources: EU EUDAMED, US FDA

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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