9 results
·
21ms
·
Sources: EU EUDAMED, US FDA
BEL BLOOD LEVEL DETECTOR
FDA 510(k)
FDA Class 2
·Cardiovascular
ADVANTAGE MULTIPLE DRUGS OF ABUSE TEST
FDA 510(k)
FDA Class 2
·Clinical Toxicology
RETRACTA DETACHABLE EMBOLIZATION COIL
FDA 510(k)
FDA Class 2
·Cardiovascular
HEART START XL
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·May 2, 2014
ASR ACETABULAR CUPS 50
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·November 8, 2012
KYPHX HV-R BONE CEMENT
FDA Adverse Event
Malfunction
·MEDTRONIC SPINE LLC.·Product code NDN·August 26, 2010
Brand Name: CLEANER BOTTLE Product Name: CLEANER BOTTLE Model/Catalog Number: EG-1000 Software Version: N/A Product Description: CLEANER bottles used with EMS AIRFLOW PROPHYLAXIS MASTER / EMS AIRFLOW ONE devices to clean the water lines. The bottle is placed on the device during cleaning. Component: YES. AIRFLOW PROPHYLAXIS MASTER and AIRFLOW PROPHYLAXIS ONE
FDA Enforcement
Class II
·Ongoing·Electro Medical Systems SA·May 1, 2024
Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
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