12 results · 23ms · Sources: EU EUDAMED, 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