9 results
·
27ms
·
Sources: EU EUDAMED, US FDA
MYLABGAMMA
FDA 510(k)
FDA Class 2
·Radiology
Suprasorb
FDA UDI
Huizhou Foryou Medical Devices Co., Ltd.·06940610115739·
MODIFICATION TO CMA CEREBRAL TISSUE MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
BITECH BIPOLAR SCISSORS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT
FDA Adverse Event
Injury
·ALLERGAN (COSTA RICA)·Product code FTR·September 3, 2019
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 4, 2014
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE·Product code KDJ·June 3, 2013
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 28, 2011
MAGNETOM Aera magnetic resonance diagnostic devices Model # 10432914
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·August 28, 2019