12 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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STRAUMANN TIBRUSH
FDA 510(k)
FDA Class 2
·Dental
CAIMAN DISP. INSTR. NON ARTICUL. D:5/360MM
FDA Adverse Event
Malfunction
·AESCULAP AG AND CO. KG·Product code GEI·December 12, 2014
SURGICAL PROCEDURE PACKS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
JETPACK 2.0
FDA 510(k)
FDA Class 2
·Radiology
BD 30ML LUER-LOK¿ SYRINGE
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMF·February 14, 2023
PARIETEX UGYTEX PP POSTERIOR KIT X1
FDA Adverse Event
Injury
·SOFRADIM PRODUCTION·Product code OTP·April 16, 2013
PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·June 2, 2011
XACT CAROTID STENT SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR-VASCULAR SOLUTIONS·Product code NIM·August 11, 2008
Microtek Franz Angiography Drape with Radiation Shield, Item # RBA202, and Microtek Angiography Drape with Radiation Shield and Pouches, Item # RBA203. Sterile EO. Microtek Medical, Inc., Columbus, MS 39702.
FDA Enforcement
Class II
·Terminated·Ecolab Inc·September 14, 2016
Quadra Assura MP, Sterile EO, Model #/ Part #: CD3269-40/100043177; CD3269-40Q/100043178; CD3271-40/100043130; CD3271-40Q/100043191; CD3369-40C/100080339, 100080478; CD3369-40Q/100080439, 100080476, 100105528; CD3371-40/100078814, 100079232, 100079513; CD3371-40C/100078639, 100079231, 100079478, 100105493, 100105494; CD3371-40Q/100078815,100079282, 100079479, 100138237; CD3371-40QC/100078640, 100079165, 100079506, 100079541, 100105505, 100105506, 100138173, 100138179, 100138222, 100138234; CD3387-40C/100105525; CD3387-40QC/100138158
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018
INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021
Model Number L231, PROPONENT DR EL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025