8 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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FILE-EZE
FDA 510(k)
FDA Unclassified
·Unknown
DETECT (TM) CYTOLOGY BRUSH
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
MICROHEMATOCRIT ROTOR
FDA 510(k)
FDA Class 2
·Hematology
RIM-LOCK BIOLOX DELTA CERAMIC LINER
FDA Adverse Event
Injury
·MICROPORT ORTHOPEDICS INC.·Product code LZO·January 6, 2025
VISUM LED SURGICAL LIGHT
FDA Adverse Event
Malfunction
·STRYKER COMMUNICATIONS·Product code FSY·January 11, 2013
STENOSCOPE
FDA Adverse Event
Malfunction
·GE MEDICAL SYSTEMS (INDIA) PRIVATE LTD·Product code JAA·November 24, 2010
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·February 4, 2014
HealthLink***BIOPSY PUNCHES*** Disposable manual instrument for skin biopsy.
FDA Enforcement
Class II
·Terminated·Clorox Healthcare Holdings, LLC (dba HealthLink)·July 10, 2013