38 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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NOFACT IX
FDA 510(k)
FDA Class 2
·Hematology
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04064984699427·GENUMEDI SILVER SIZE VIII
Endo Carry-On Procedure Kit
FDA UDI
MEDIVATORS INC.·00677964076893·Endo Carry-On Procedure Kit
Plateau Spacer System
FDA UDI
Life Spine, Inc.·00190837026851·PLATEAU Interbody, Curved, Bulleted, 11mm 29mm ...
JET THERAPY
FDA 510(k)
FDA Class 1
·Physical Medicine
BIOPLATE RESORBABLE BONE SCREW
FDA 510(k)
FDA Class 2
·Dental
10 ML BD POSIFLUSH¿ NORMAL SALINE SYRINGE, IN 10 ML SYRINGE
FDA Adverse Event
Death
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code NGT·September 11, 2018
CYTOMAX II DOUBLE LUMEN CYTOLOGY BRUSH
FDA Adverse Event
Injury
·COOK ENDOSCOPY·Product code FDX·February 22, 2021
GLIDESHEATH SLENDER NITINOL (CONVENIENCE KIT)
FDA Adverse Event
Malfunction
·TERUMO MEDICAL CORPORATION·Product code DYB·February 21, 2018
VERIFLEX?
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - GALWAY·Product code MAF·May 9, 2013
ETRIO
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GEI·September 19, 2014
INTRACRANIAL PRESSURE / TEMPERATURE MONITORING K
FDA Adverse Event
Malfunction
·INTEGRA, SAN DIEGO·Product code GWM·May 4, 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