25 results · 29ms · Sources: EU EUDAMED, 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