7 results
·
23ms
·
Sources: EU EUDAMED, US FDA
ESPE CHELON-SILVER
FDA 510(k)
FDA Class 2
·Dental
MARTANIQUE 7-TUBE RUVA HOME SOLARIUM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
TOTAL CHOLESTEROL REAGENT SET
FDA 510(k)
FDA Class 1
·Clinical Chemistry
DEPUY ASR XL FEM IMP SIZE 43
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD. 8010379·Product code KXA·June 11, 2014
CAPSUREFIX NOVUS
FDA Adverse Event
MEDTRONIC PUERTO RICO, INC.·Product code DTB·October 12, 2010
DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER
FDA Adverse Event
Malfunction
·MPRI·Product code LWS·December 10, 2012
Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 26, 2015