14 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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NOVA Minimally Invasive System
FDA 510(k)
FDA Class 2
·Orthopedic
OsteoMed
FDA UDI
OSTEOMED LLC·00842528127803·2.4 X 16mm Cannulated Headed Screw, T7
IBA PROTON THERAPY SYSTEM- PROTEUS 235
FDA 510(k)
FDA Class 2
·Radiology
BD GENEOHM VANR ASSAY
FDA 510(k)
FDA Class 2
·Microbiology
PRUITT F3 CAROTID SHUNT
FDA Adverse Event
Malfunction
·LEMAITRE VASCULAR, INC.·Product code MJN·May 21, 2021
APTIMA COMBO 2 ASSAY
FDA Adverse Event
Injury
·HOLOGIC INCORPORATED·Product code LSL·October 17, 2014
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM.
FDA Adverse Event
Malfunction
·COCHLEAR LTD·Product code MCM·July 28, 2011
7900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·June 14, 2013
PRUITT F3 CAROTID SHUNT
FDA Adverse Event
Injury
·LEMAITRE VASCULAR, INC.·Product code MJN·May 21, 2021
PRUITT F3 CAROTID SHUNT
FDA Adverse Event
Malfunction
·LEMAITRE VASCULAR, INC.·Product code MJN·May 21, 2021
COMPREHENSIVE SHOULDER SYSTEM NANO HUMERAL COMP
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code HSD·September 26, 2023
COMPR NANO HMRL PPS 34MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWS·June 10, 2024
PRUITT F3 CAROTID SHUNT
FDA Adverse Event
Malfunction
·LEMAITRE VASCULAR, INC.·Product code MJN·April 23, 2021
COMPREHENSIVE SHOULDER SYSTEM NANO NUMERAL COMPONENT 30 MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code HSD·March 21, 2024