8 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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HOLLYWOODS COOL SHADES
FDA 510(k)
FDA Class 1
·Ophthalmic
MEDI-TRACE INFANT ELECTRODE
FDA 510(k)
FDA Class 2
·Cardiovascular
LABEL CHG FOR ERIKA MODEL 9608 ARTERIAL BLOOD LINE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ANIMAS VIBE
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 16, 2014
AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code FNL·December 15, 2012
ENDOTAK RELIANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVY·October 19, 2010
GLOBAL UNITE STD STEM SZ 10 Part Number: 110010100
FDA Enforcement
Class II
·Terminated·DePuy Orthopaedics, Inc.·January 19, 2022
B125P Patient Monitor (with E-module slot option), REF 6160000-002
FDA Enforcement
Class II
·Ongoing·GE Medical Systems, LLC·December 28, 2022