12 results
·
27ms
·
Sources: EU EUDAMED, US FDA
ANAEROBE BLOOD AGAR
FDA 510(k)
FDA Class 1
·Microbiology
OVATION®
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K82055261·OVATION® Base Rx SP 022 UL/5-5 CS-BC DHK
OVATION®
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K82055241·OVATION® Base Rx 022 UL/5-5 CS-BC MHK
OVATION®
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K82055221·OVATION® Base Rx 022 UL/5-5 CS-BC DHK
17HQ901G-B
FDA 510(k)
FDA Class 2
·Radiology
AESCULAP-MEITHKE PROSA ADJUSTABLE SHUNT SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172973493·
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code KWP·May 20, 2014
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·November 2, 2012
CHRONOS BETA-TCP STRIP-STERILE
FDA Adverse Event
Injury
·NORIAN CORPORATION·Product code MQV·August 26, 2010
BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·April 21, 2021
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