14 results · 23ms · Sources: EU EUDAMED, US FDA

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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