14 results
·
23ms
·
Sources: EU EUDAMED, US FDA
LATEX PENROSE DRAIN TUBING
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Invenio
FDA UDI
Gri-Alleset, Inc.·00840365901044·Vein RF Kit
STRADIS
FDA UDI
STRADIS MEDICAL, LLC·M75268217001·CUSTOM SURGICAL KIT VEIN PACK
STRADIS HEALTHCARE
FDA UDI
STRADIS MEDICAL, LLC·M75268217000·CUSTOM SURGICAL KIT VEIN PACK
ULTHERA SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ANIMUS EZSERTER INFUSION SET INSERTER
FDA 510(k)
FDA Class 2
·General Hospital
M2A-MAGNUM PF CUP 46ODX40ID
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·October 9, 2018
EXACTECH NOVATION CROWN CUP AND LINERS
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JDI·September 3, 2024
M2A-MAGNUM PF CUP 46ODX40ID
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·October 9, 2018
ACCU-CHEK ® AVIVA PLUS TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·May 20, 2014
OT VERIO PRO METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·November 6, 2012
LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC·Product code MKJ·August 25, 2010
SYRINGE INSULIN 0.5ML 31GA 8MM W30 SELF
FDA Adverse Event
Malfunction
·BECTON DICKINSON DE MEXICO·Product code FMF·September 17, 2020
OEC 9800; OEC FluoroTrak 9800 Plus; OEC 9800 Plus; OEC 9800 MD Motorized C-arm System, 892.1650 Image-intensified fluoroscopic x-ray system. The OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. The system includes features specifically designed for use in diagnostic and interventional cardiac imaging procedures and is also intended for cholangiography, endoscopic, urologic orthopedic, neurologic, vascular, critical care and emergency room procedures. It may be used for other imaging applications at the physician's discretion.
FDA Enforcement
Class I
·Terminated·GE OEC Medical Systems, Inc·August 1, 2012