13 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ISOLYSER SHARPS ROOM SYSTEM, MODEL 800; ISOLYSER SHARPS MANAGEMENT SYSTEM, MODELS 2400, 4000, 10000
FDA 510(k)
FDA Class 2
·General Hospital
ALERE DETERMINE HIV 1/2 AG/AB COMBO
FDA Adverse Event
Malfunction
·ALERE SCARBOROUGH INC.·Product code MZF·June 12, 2018
ALERE DETERMINE HIV 1/2 AG/AB COMBO
FDA Adverse Event
Malfunction
·ALERE SCARBOROUGH INC.·Product code MZF·June 12, 2018
SMART SHIELD NON-STERILE POWDER-FREE PEPPERMINT SCENTED GREEN LATEX EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
SLEEP PAT 200 DEVICE
FDA 510(k)
FDA Class 2
·Anesthesiology
ALERE DETERMINE HIV 1/2 AG/AB COMBO
FDA Adverse Event
Malfunction
·ALERE SCARBOROUGH INC.·Product code MZF·June 12, 2018
ALERE DETERMINE HIV 1/2 AG/AB COMBO
FDA Adverse Event
Malfunction
·ALERE SCARBOROUGH INC.·Product code MZF·June 14, 2018
ALERE DETERMINE HIV 1/2 AG/AB COMBO
FDA Adverse Event
Malfunction
·ALERE SCARBOROUGH INC.·Product code MZF·June 14, 2018
ALERE DETERMINE HIV 1/2 AG/AB COMBO
FDA Adverse Event
Malfunction
·ALERE SCARBOROUGH INC.·Product code MZF·June 12, 2018
ALERE DETERMINE HIV 1/2 AG/AB COMBO
FDA Adverse Event
Malfunction
·ALERE SCARBOROUGH INC.·Product code MZF·June 12, 2018
RIATA ACTIVE FIXATION
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·May 2, 2013
ASR UNI FEMORAL IMPL SIZE 47
FDA Adverse Event
Injury
·DEPUY INTL., LTD. ¿ REG. # 8010379·Product code KWA·September 15, 2014
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·May 5, 2011