8 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ASSERT TM BIOLOGICAL/CHEMICAL INDICATOR
FDA 510(k)
FDA Class 2
·General Hospital
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690128595·Revision Fluted Stem 10mm x 100mm
BIONOMY'S MULTI-LUMEN CENTRAL VENOUS CATHETER-SET
FDA 510(k)
FDA Class 2
·General Hospital
GDC-1629 A CASTING ALLOY
FDA 510(k)
FDA Class 2
·Dental
OT VERIO IQ METER
FDA Adverse Event
Injury
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 9, 2014
3005075853-2010-05718
FDA Adverse Event
Product code GCJ·October 6, 2010
VENTED AUTOFEED CHAMBER
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·December 3, 2012
Philips Ingenia Ambition S with MR Elastography (MRE). 1. Model Number (REF): 781359. 2. Model Number (REF): 782108. 3. Model Number (REF): 782139.
FDA Enforcement
Class II
·Ongoing·Philips North America·May 6, 2026