7 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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WELLS LAMONT CUT RESISTANT SURGICAL GLOVE LINERS
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
16ch Breast Coil / 16ch Breast Coils, 1.5T 16ch Breast Coil, 3.0T 16ch Breast Coil, 1.5T 16ch Breast Coil, 3T 16ch Breast Coil
FDA 510(k)
FDA Class 2
·Radiology
MULTI FUCTIONAL REHABILITATION CHAIR
FDA 510(k)
FDA Class 2
·Physical Medicine
INOMAX DSIR (DELIVERY SYSTEM)
FDA Adverse Event
Malfunction
·IKARIA·Product code MRN·June 3, 2014
DUAL COOLER/HEATER
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DWC·January 14, 2013
VIRTUOSO DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code LWS·December 13, 2010
ACCESS SARS-CoV-2 IgG QC SARS-CoV-2 IgG REF C58964 - Product Usage: use on the Access Family of Immunoassay Systems only.
FDA Enforcement
Class II
·Terminated·Beckman Coulter Inc.·January 27, 2021