11 results
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19ms
·
Sources: EU EUDAMED, US FDA
VASOGENICS EECP-MC2
FDA 510(k)
FDA Class 2
·Cardiovascular
VARIAX
FDA UDI
Stryker GmbH·07613327125771·Medial Elbow Plate Insert
CALIBRATOR FOR AUTOMATED SYSTEMS PROTEINS IN URINE/CSF
FDA 510(k)
FDA Class 2
·Clinical Chemistry
MADM
FDA 510(k)
FDA Class 2
·Anesthesiology
PINNACLE MTL INS NEUT36IDX56OD
FDA Adverse Event
Injury
·DEPUY INTL., LTD. ¿ REG. # 8010379·Product code KWA·September 8, 2014
ARTICULEZE M HEAD 36MM +1.5
FDA Adverse Event
Injury
·DEPUY INTL., LTD. ¿ REG. # 8010379·Product code JDI·September 8, 2014
HIRES 90K ADVANTAGE IMPLANT
FDA Adverse Event
Injury
·ADVANCED BIONICS LLC·Product code MCM·June 19, 2014
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·February 2, 2013
RENAL - DISPOSABLE
FDA Adverse Event
Injury
·Product code KDJ·December 29, 2010
OPERATING CYSTOSCOPE-URETHROSCOPE
FDA Adverse Event
Death
·KARL STORZ SE & CO. KG·Product code FGB·March 8, 2023
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