18 results
·
50ms
·
Sources: EU EUDAMED, US FDA
GEL-FILLED MAMMARY PROSTHESIS
FDA Adverse Event
Injury
·AMERICAN HEYER-SCHULTE·Product code FTR·March 6, 1998
STERIS QUICK CONNECT
FDA Adverse Event
Malfunction
·STERIS CORP NO. AMERICAN HEALTHCARE DIV.·Product code MLR·August 9, 2001
BD Nano 2nd Gen Pen Needles 32G X 4mm (5-count sample contained in Patient Counseling Sample Toolbox -Catalog 6484755/Lot Number: 3750144)-Sterile, single use devices designed for the parenteral administration of a drug from a cartridge contained in a drug pen injector Model/Catalog Number: 320551
FDA Recall
Open, Classified
·Embecta Corp.·Product code FMI·June 18, 2024
HEYER-SCHULTE JACKSON-PRATT DRAIN 10 MM
FDA Adverse Event
Injury
·BAXTER-AMERICAN V. MUELLER, BAXTER HEALTHCARE CORP.·Product code GCY·November 7, 1995
mdi Europa GmbH
Authorized representative
🇩🇪 Germany·132 Manufacturers·4741 Devices
Medical Technology Promedt Consulting GmbH
Authorized representative
🇩🇪 Germany·194 Manufacturers·10009 Devices
Obelis s.a.
Authorized representative
🇧🇪 Belgium·546 Manufacturers·18515 Devices
Emergo Europe B.V.
Authorized representative
🇳🇱 Netherlands·900 Manufacturers·22100 Devices
MedNet EC-REP GmbH
Authorized representative
🇩🇪 Germany·464 Manufacturers·5263 Devices
MDSS GmbH
Authorized representative
🇩🇪 Germany·388 Manufacturers·16562 Devices
MedEnvoy Global BV
Importer
🇳🇱 Netherlands·234 Manufacturers
PRIM, S.A.
Importer
🇪🇸 Spain·64 Manufacturers
MedPath GmbH
Authorized representative
🇩🇪 Germany·537 Manufacturers·13464 Devices
VidiStar(TM) PACS & DICOM Viewer Software system
FDA Enforcement
Class II
·Terminated·Hitachi Healthcare Americas Corp Informatics Division·September 12, 2018
FUJIFILM Europe B.V.
Importer
🇳🇱 Netherlands·19 Manufacturers
European Healthcare & Device Solutions Ltd.
Authorized representative
🇮🇪 Ireland·66 Manufacturers·867 Devices
Advena Limited
Authorized representative
🇲🇹 Malta·467 Manufacturers·13717 Devices
CEpartner4U
Authorized representative
🇳🇱 Netherlands·160 Manufacturers·5787 Devices