7 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BAG DECANTER
FDA 510(k)
FDA Class 2
·General Hospital
SPETZLER SCALP RETRACTOR CLAMPS (VARIOUS STYLES AND SIZES)
FDA 510(k)
FDA Class 2
·Neurology
Bluephase PowerCure
FDA 510(k)
FDA Class 2
·Dental
ACCU-CHEK ® MULTICLIX
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code FMK·December 28, 2012
FORTIFY DR, DF-4 CONNECTOR
FDA Adverse Event
Injury
·ST. JUDE MEDICAL INC., CRMD·Product code LWS·January 13, 2014
9600
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·October 22, 2010
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS TRACHEOSTOMY TUBE 7.0MM TIGHT TO SHAFT CUFF, Product Code/List Number/Item Code 670170; b) TTS TRACHEOSTOMY TUBE 8.0MM TIGHT TO SHAFT CUFF 1/EA, Product Code/List Number/Item Code 670180
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·September 4, 2024