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

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EAR/ULCER SYRINGE

FDA 510(k)
FDA Class 1 ·Ear, Nose, Throat

ViewMate Multi Ultrasound System

FDA 510(k)
FDA Class 2 ·Radiology

S&T SINGLE USE MICRO ANASTOMOSIS CLAMP

FDA 510(k)
FDA Class 2 ·Cardiovascular

9800

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·February 7, 2014

DUAL COOLER/HEATER

FDA Adverse Event
Malfunction ·TERUMO CARDIOVASCULAR SYSTEM CORP·Product code DWC·November 2, 2012

SIMPLEX P - CE ABC FD 10-PK

FDA Adverse Event
Death ·STRYKER ORTHOPAEDICS LIMERICK·Product code LOD·August 30, 2010

NAMIC Convenience Kit, LEFT HEART KIT, UPN H965601017731, REF/Catalog No. 60101773, STERILE, Rx ONLY ---For single use only. --- Device Listing Number D136588. NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems

FDA Enforcement
Class II ·Terminated·Navilyst Medical, Inc·March 4, 2015

OEC MiniView 6800 Mobile; MDL number A349855. Product Usage: The mini 6800 digital mobile c arm is designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical, orthopedic, and extremity imaging. The device is not intended for whole body pediatric imaging.

FDA Enforcement
Class II ·Terminated·GE OEC Medical Systems, Inc·August 8, 2012

UroView 2800; MDL number A349855. Product Usage: Designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical, and interventional procedures. Clinical application may include but are not limited to urologic and endoscopic procedures. The system may be ued for other imaging applications at the physician's discretion.

FDA Enforcement
Class II ·Terminated·GE OEC Medical Systems, Inc·August 8, 2012

OEC 9800 Plus Digital; MDL number A349855. Product Usage: Is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. Clinical applications may include cholangiography, endoscopic, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures. The system may be used for other imaging applications at the physician's discretion.

FDA Enforcement
Class II ·Terminated·GE OEC Medical Systems, Inc·August 8, 2012