8 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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HEMOVAC AUTOTRANSFUSION SYSTEM
FDA 510(k)
FDA Class 2
·Anesthesiology
Grasping forceps
FDA UDI
SOPRO-COMEG GmbH·04059082022734·
Onetouch Non-paraben Lubricant Gel
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
KITTYCAT CATHETER, KITTYCAT 2 CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
RADIOTHERAPEUTICS RF 3000 RADIOFREQUENCY GENERATOR
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code GEI·December 10, 2010
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·July 8, 2014
KEEPSAFE DELUXE
FDA Adverse Event
Malfunction
·J. T. POSEY CO.·Product code KMI·December 17, 2012
Sternal Valve Retractors With Atrial and Aortic Rakes; Models SRCL-1, SRCL-AR, SRLP-1, SRLP-AR, ATR-1, ATR-AR, CSR-1 and CSR-AR. For use in cardiac surgery.
FDA Enforcement
Class II
·Ongoing·Genesee BioMedical, Inc.·June 6, 2018