10 results
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27ms
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Sources: EU EUDAMED, US FDA
ARBO DIAGNOSTIC ECG PATIENT CABLES & LEADWIRES ARBO SHIELDED MULTI-LEAD CABLE & LEAD SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
3M™ ESPE™
FDA UDI
3M COMPANY·30605861030633·3M™ ESPE™ Gold Anodized Crown Refills, First Mo...
N/A
FDA UDI
Tyber Medical, LLC·M695M9403230·
SILICONE SUCTION & IRRIGATION DRAIN
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
NAVIGATOR HD URETERAL ACCESS SHEATH SETS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
DORSEY FENESTRATED GRASPER 25MM JAW ESU
FDA Adverse Event
Injury
·CAREFUSION, INC·Product code GEI·January 15, 2019
C-QUR MESH
FDA Adverse Event
Injury
·ATRIUM MEDICAL CORP.·Product code FTL·June 26, 2014
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·February 2, 2013
SM104 MSERIES W5TH WHL
FDA Adverse Event
Malfunction
·STRYKER CORP., MEDICAL DIVISION·Product code FPO·December 9, 2010
Captus 4000e Thyroid Uptake System, Model Numbers 5430-30151 and 5430-30152 - Product Usage: is intended to be used by trained nuclear Medicine Technologists or Nuclear Medicine Physicians to perform Thyroid Uptake Procedures.
FDA Enforcement
Class II
·Terminated·Capintec Inc·April 1, 2020