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

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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