9 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DART DAILY AIR REMOVAL TEST
FDA 510(k)
FDA Class 2
·General Hospital
SANDMILL RMS
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
STREPTOCOCCUS PNEUMONIAE CONTROL
FDA 510(k)
FDA Class 1
·Microbiology
OT VERIO PRO PLUS METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 3, 2014
OCTRODE
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·November 16, 2012
COSYCOT INFANT WARMER
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD.·Product code FMT·September 26, 2010
HUDSON ET TUBE, UNCUFFED, 3.0
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code BTR·October 20, 2015
HUDSON ET TUBE, UNCUFFED, 3.0
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code BTR·October 20, 2015
Breast Augmentation Pack, part number AMS1786(A Breast Augmentation Pack, part number AMS2790(A Breast Augmentation Pack, part number AMS3324(B Breast Augmentation Pack, part number AMS4382 Breast Augmentation Pack, part number AMS4382(A Breast Augmentation Pack, part number AMS4382(B Breast Augmentation Pack, part number AMS4392 Breast Augmentation Pack, part number PSS3430
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017