13 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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FRANCE ORTHODONTIE
FDA 510(k)
FDA Class 2
·Dental
SpiritMB
FDA UDI
ORMCO CORPORATION·00889989007312·ID D - Twin - Upper-Left Central - Blue
Sierra
FDA UDI
Seaspine Orthopedics Corporation·10889981094348·Variable Drill
Prophy Brush
FDA UDI
DiaDent Group International·08806383525770·A non-sterile rotary dental instrument with nat...
Zimmer Periarticular Plating System
FDA 510(k)
FDA Class 2
·Orthopedic
ZIMMER PERIARTICULAR LOCKING PLATE SYSTEM, MODEL 2357 & 2359
FDA 510(k)
FDA Class 2
·Orthopedic
ENDOPATH** DEXTRUS*
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY, LLC.·Product code GCJ·February 8, 2013
CLEARSTAR PUMP
FDA Adverse Event
Malfunction
·ABBOTT NUTRITION·Product code LZH·December 9, 2010
VALIANT
FDA Adverse Event
Malfunction
·MEDTRONIC IRELAND·Product code MIH·July 22, 2014
EVOLUT FX VALVE
FDA Adverse Event
Malfunction
·MEDTRONIC MEXICO S. DE R.L. DE CV·Product code NPT·March 10, 2026
EVOLUT FX VALVE
FDA Adverse Event
Malfunction
·MEDTRONIC MEXICO S. DE R.L. DE CV·Product code NPT·March 10, 2026
IntelliSpace Portal (ISP), (ISP DX/HX/EX, Model number 881001; ISP IX, Model number 881030; ISP LX SPECT, Model number 881035), Philips Medical Systems. A medical software system for diagnostic imaging data viewing.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·June 11, 2014
IntelliSpace Portal (ISP) DX/HX/EX, IntelliSpace Portal (ISP) IX, and IntelliSpace Portal (ISP) LX SPECT IntelliSpace Portal (ISP) is a multimodality (CT, NM, and MR) thin-client applications server that delivers full diagnostic viewing and clinical applications to the enterprise. IntelliSpace Portal (ISP) is a medical software system that allows multiple users to remotely access IntelliSpace Workspace Portal (ISP) from compatible computers on a network. The system allows networking, selection, processing and filming of multimodality DICOM images.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·August 20, 2014