18 results · 41ms · Sources: EU EUDAMED, US FDA

Elecsys Troponin Gen 5 CalCheck 5

FDA registration
ROCHE DIAGNOSTICS GMBH·4 products·🇩🇪 Germany

Elecsys Troponin T Gen 5 STAT Assay, Elecsys Troponin T Gen 5 STAT CalSet, Elecsys PreciControl Troponin, Elecsys Troponin T Gen 5 CalCheck 5

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

Immunoassay Method, Troponin Subunit

FDA classification
FDA Class 2 ·Immunoassay Method, Troponin Subunit

Schneider ASR B.V.

FDA registration
Schneider ASR B.V.·1 product·🇳🇱 Netherlands

Miru 1day Menicon Flat Pack

FDA registration
Menicon Singapore Pte. Ltd.·1 product·🇸🇬 Singapore

D296680

FDA registration
1800 CONTACTS, INC·1 product·🇺🇸 United States

Miru 1day Menicon Flat Pack

FDA registration
MENICON CO. LTD.·1 product·🇯🇵 Japan

Miru 1day Menicon Flat Pack

FDA registration
Menicon Singapore Pte. Ltd. (Site 2)·1 product·🇸🇬 Singapore

DORC10527 (PL) - endoilluminator

FDA registration
Isomedix Operations Inc.·1 product·🇺🇸 United States

27G Chandelier fiber and 23G standard D-style fiber optic handpiece incl. guidance needle.

FDA registration
D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.·1 product·🇳🇱 Netherlands

D.O.R.C. (VL1) - Endoilluminator

FDA registration
Synergy Health Ede BV·1 product·🇳🇱 Netherlands

Miru 1day Menicon Flat Pack

FDA registration
Menicon Co., Ltd., R&D Center·1 product·🇯🇵 Japan

Ophthalmic endoilluminator

FDA registration
Sterigenics Belgium Petit Rechain S.A.·1 product·🇧🇪 Belgium

Lumipulse G Wash Solution 4008248

FDA registration
Fujirebio Inc. Ube Facility·3 products·🇯🇵 Japan

ONE DAY FLAT PACK

FDA 510(k)
FDA Class 2 ·Ophthalmic

XENON BRIGHTSTAR ILLUMINATION SYSTEM, MODEL 1266.XIII

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

Endoilluminator

FDA classification
FDA Class 2 ·Endoilluminator

Lenses, Soft Contact, Daily Wear

FDA classification
FDA Class 2 ·Lenses, Soft Contact, Daily Wear