8 results
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17ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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WILSON-COOK CYTOLOGY BRUSHES
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Arthrex®
FDA UDI
ARTHREX, INC.·00888867364332·Cup Curette, 9mm
VINYL EXAM GLOVES (MFG. UNIVERSAL GLOVE CORP.)
FDA 510(k)
FDA Class 1
·General Hospital
PATIENT EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
TENDRIL SDX
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·November 10, 2010
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORP.·Product code FRN·January 16, 2014
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·December 5, 2012
DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE, E-MINIC AND ACCESSORIES. DATEX-OHMEDA S/5TM FM WITH L-FICU04 ANDL-FICUO4A SOFTWARE AND N-FCREC MODULE **(OUS only). E-miniC and accessories is indicated for monitoring C02 and respiration rate of all hospital patients.
FDA Enforcement
Class I
·Terminated·GE Healthcare, LLC·July 30, 2014