7 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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FISHER PRICE SUNJAMMERS
FDA 510(k)
FDA Class 1
·Ophthalmic
RESPIRALEX LATEX AGGLUTINATION TEST
FDA 510(k)
FDA Class 1
·Microbiology
NEW MOTHER'S WAY-BREAST PUMP
FDA 510(k)
FDA Class 1
·Obstetrics/Gynecology
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·June 10, 2014
PFC SIGMA C/S NPOR FEM LT SZ 4
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code JWH·October 6, 2010
OCTRODE
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·December 6, 2012
e.cam line of gamma camera systems Used to detect or image the distribution of radionuclides in the body or organ.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc.·October 29, 2014