13 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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KARL STORZ BOUGIES AND DILATORS
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
DD base P HI
FDA UDI
Dental Direkt GmbH·EDDIK501251·DD medical polymers (PMMA), made from PMMA, are...
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690117490·Distal Reamer (Hudson)
Sierra
FDA UDI
Seaspine Orthopedics Corporation·10889981094386·Seat Alignment Tool
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690192664·Distal Reamer (Hudson)
RAP/TAC/CSA CONTROL - LEVEL 1,2,3,4
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Elite Nitinol Fixation System
FDA 510(k)
FDA Class 2
·Orthopedic
Optetrak Logic
FDA UDI
Exactech, Inc.·10885862201492·X-RAY TEMPLATE, LOGIC, SIZE 2.5, PS/CR
Truliant
FDA UDI
Exactech, Inc.·10885862548641·TRULIANT XRAY TEMPLATE, SIZE 2.5, 115%
FRESENIUS 2008K
FDA Adverse Event
Injury
·FRESENIUS MEDICAL CARE·Product code KDI·June 27, 2014
RIATA ACTIVE FIXATION
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·February 8, 2013
PLMA DVC V11.51 1 N
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·December 9, 2010
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