25 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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EleVation Breast Biopsy Driver, EleVation Breast Biopsy Probe - 10G, EleVation Breast Biopsy Probe - 14G
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Sklar®
FDA UDI
SKLAR CORPORATION·10649111389757·HUNTER SPLINTER FCP CVD 4 1/4"
APLIO MX SSA-780A, VERSION 1.0
FDA 510(k)
FDA Class 2
·Radiology
TORFLEX TRANSSEPTAL GUIDING SHEATH
FDA 510(k)
FDA Class 2
·Cardiovascular
CYTOMAX II DOUBLE LUMEN CYTOLOGY BRUSH
FDA Adverse Event
Injury
·COOK ENDOSCOPY·Product code FDX·February 22, 2021
ACCESS
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FPA·October 22, 2014
ARTICULEZE M HEAD 36MM +1.5
FDA Adverse Event
Injury
·8010379 DEPUY INTL., LTD.·Product code JDI·June 27, 2013
7MM EXTENDED LENGTH ENDOSCOPE
FDA Adverse Event
Malfunction
·MAQUET CARDIOVASCULAR·Product code GCJ·July 21, 2011
FUSION CYTOLOGY BRUSH
FDA Adverse Event
Malfunction
·COOK ENDOSCOPY·Product code FDX·January 6, 2022
FUSION CYTOLOGY BRUSH
FDA Adverse Event
Injury
·COOK ENDOSCOPY·Product code FDX·October 25, 2021
CYTOMAX II DOUBLE LUMEN CYTOLOGY BRUSH
FDA Adverse Event
Injury
·WILSON-COOK MEDICAL INC·Product code FDX·May 4, 2022
CYTOMAX II DOUBLE LUMEN CYTOLOGY BRUSH
FDA Adverse Event
Injury
·WILSON-COOK MEDICAL INC·Product code FDX·November 14, 2022
Baylis Medical TorFlex Transseptal Guiding Sheath, Rx Only, non-pyrogenic, sterile. Product Usage: The TorFlex Transseptal Guiding Sheath kit (K102948) is a single use device consisting of three components: a sheath, a dilator, and a J-tipped guidewire. The kit is designed for safe and easy catheterization and angiography of specific heart chambers and locations.
FDA Recall
Terminated
·Baylis Medical Corp 5959 TransCanada Highway Montreal Canada·Product code DYB·September 23, 2013
CYTOMAX II DOUBLE LUMEN CYTOLOGY BRUSH
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC·Product code FDX·August 27, 2024
FUSION CYTOLOGY BRUSH
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC·Product code FDX·July 31, 2024
CYTOMAX II DOUBLE LUMEN CYTOLOGY BRUSH
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC·Product code FDX·May 28, 2024
CYTOMAX II DOUBLE LUMEN CYTOLOGY BRUSH
FDA Adverse Event
Injury
·WILSON-COOK MEDICAL INC·Product code FDX·May 31, 2024
CYTOMAX II DOUBLE LUMEN CYTOLOGY BRUSH
FDA Adverse Event
Injury
·COOK ENDOSCOPY·Product code FDX·September 14, 2021
FUSION CYTOLOGY BRUSH
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC·Product code FDX·November 12, 2024
CYTOMAX II DOUBLE LUMEN CYTOLOGY BRUSH
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC·Product code FDX·January 13, 2025