22 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MAXEMS, MODELS 1000 AND 2000
FDA 510(k)
FDA Class 2
·Physical Medicine
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450269466·
NA
FDA UDI
STERILMED, INC.·10888551018159·BUR MICRO WIRE PASS 2 FLUTES MEDIUM
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450209998·
CONMED
FDA UDI
Conmed Corporation·10845854001417·WIRE PASS DRILL, MEDIUM, 1.5 X 19 MM
CW DISPOSABLE ACUPUNCTURE NEEDLE
FDA 510(k)
FDA Class 2
·General Hospital
MULTI-PULSE 2000
FDA 510(k)
FDA Class 2
·Dental
INFUSE BONE GRAFT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code NEK·January 28, 2010
INFUSE BONE GRAFT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code NEK·January 28, 2010
INFUSE BONE GRAFT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code NEK·January 28, 2010
INFUSE BONE GRAFT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code NEK·January 28, 2010
INFUSE BONE GRAFT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code NEK·January 28, 2010
INFUSE BONE GRAFT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code NEK·January 28, 2010
DPM 6 MONITOR
FDA Adverse Event
Malfunction
·MINDRAY DS USA, INC.·Product code MHX·April 30, 2013
GRANUFLO
FDA Adverse Event
Injury
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·September 5, 2014
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORP.·Product code LZG·April 20, 2011
EVOLUT FX PLUS VALVE
FDA Adverse Event
Injury
·MEDTRONIC MEXICO S. DE R.L. DE CV·Product code NPT·October 7, 2025
BIPAP AUTOSV ADV
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code MNS·March 10, 2022
INFUSE BONE GRAFT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code NEK·September 2, 2025
Custom Fluid Management Set, Sterile, EO, Rx Only Used to transfer contrast media and saline from a container to a patients vascular system.
FDA Enforcement
Class II
·Terminated·Merit Medical Systems, Inc.·November 30, 2016