11 results
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18ms
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Sources: EU EUDAMED, US FDA
ENTROKIT WITH MAGLINTE CATHETER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PANOVIEW
FDA UDI
Richard Wolf GmbH·04055207021132·TELESCOPE 0° Ø 1.9MM SL 120MM rigid, TL 181mm,...
Cardiac Workstation
FDA UDI
Philips Medical Systems Hsg·00884838094833·Cardiac Workstation 7000
VITA VM 7, MODEL NX77 XXXX, NX78XXXX, NX79 XXXX; VITA VM 8, MODEL VX60 XXXX, VX61 XXXX, VX62 XXXX; VITA VM 9, MODEL NX98
FDA 510(k)
FDA Class 2
·Dental
Identic and KromaFaze Alginate Dental Impression Materials
FDA 510(k)
FDA Class 2
·Dental
Cardiac Workstation 7000; Model Number: 860441;
FDA Enforcement
Class II
·Ongoing·Philips North America·October 22, 2025
2800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 15, 2014
ENDOTAK RELIANCE
FDA Adverse Event
Malfunction
·CPI - DEL CARIBE·Product code NVY·October 7, 2010
LIGASURE IMPACT THORACIC
FDA Adverse Event
Malfunction
·COVIDIEN LLC (SHANGHAI)·Product code GEI·November 5, 2012
Cardiac Workstation 7000; Model Number: 860441;
FDA Recall
Open, Classified
·Philips North America·Product code DPS·September 12, 2025
OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.
FDA Enforcement
Class I
·Terminated·GE OEC Medical Systems, Inc·August 1, 2012