15 results
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57ms
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Sources: EU EUDAMED, US FDA
KONAN MEDICAL USA, INC.
Manufacturer
🇺🇸 United States·3 Importers
KONAN MEDICAL USA, INC.
FDA registration
KONAN MEDICAL USA, INC.·6 products·🇺🇸 United States
NA
FDA UDI
KONAN MEDICAL USA, INC.·04582275270020·
NA
FDA UDI
KONAN MEDICAL USA, INC.·04582275270075·
NA
FDA UDI
KONAN MEDICAL USA, INC.·04582275270068·
NA
FDA UDI
KONAN MEDICAL USA, INC.·04582275270037·
N/A
FDA UDI
KONAN MEDICAL USA, INC.·04582275270051·
NA
FDA UDI
KONAN MEDICAL USA, INC.·04582275270082·
NA
FDA UDI
KONAN MEDICAL USA, INC.·04582275270044·
MEyeTech GmbH
Importer
🇩🇪 Germany·8 Manufacturers
"MEDICAL PARTNER SPÓŁKA Z OGRANICZONĄ ODPOWIEDZIALNOŚCIĄ"
Importer
🇵🇱 Poland·15 Manufacturers
Rockmed BV
Importer
🇳🇱 Netherlands·18 Manufacturers
Medical Technology Promedt Consulting GmbH
Authorized representative
🇩🇪 Germany·194 Manufacturers·10009 Devices
EVICEL Fibrin Sealant (Human) Rx Only. Manufacturer: Omrix Biopharmaceuticals Ltd. MDA blood bank, Sheba Hospital, Ramat-Gan, POB 888, Kiryat Ono 55000 Israel U.S. License No. 1603. Distributed by: Ethicon, Inc. P.O. Box 151, Somerville, NJ 08876-0151 USA. The Pressure Regulator System is positioned on the floor or on an IV pole and accepts medical gas (compressed air, nitrogen, CO2) from the central hospital system or from medical gas cylinders.
FDA Enforcement
Class II
·Terminated·Ethicon, Inc.·October 31, 2012
EVICEL Fibrin Sealant (Human) Rx Only. Manufacturer: Omrix Biopharmaceuticals Ltd. MDA blood bank, Sheba Hospital, Ramat-Gan, POB 888, Kiryat Ono 55000 Israel U.S. License No. 1603. Distributed by: Ethicon, Inc. P.O. Box 151, Somerville, NJ 08876-0151 USA. The Pressure Regulator System is positioned on the floor or on an IV pole and accepts medical gas (compressed air, nitrogen, CO2) from the central hospital system or from medical gas cylinders.
FDA Recall
Terminated
·Ethicon, Inc. US·Product code FMF·July 2, 2012