12 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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IS-1/QUADRIPOLAR TERMINAL CAP, PART NUMBER 6011069
FDA 510(k)
FDA Class 2
·Cardiovascular
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690192640·Distal Reamer 14mm (Zimmer)
Sierra
FDA UDI
Seaspine Orthopedics Corporation·10889981094522·Rod Holder
Defendo Fujifilm 700 Single Use Cleaning Adapter
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MCL 31 Dermablate
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Optetrak Logic
FDA UDI
Exactech, Inc.·10885862201522·X-RAY TEMPLATE, LOGIC, SIZE 4, PS/CR
Truliant
FDA UDI
Exactech, Inc.·10885862548672·TRULIANT XRAY TEMPLATE, SIZE 4, 115%
UNKNOWN
FDA Adverse Event
WILLIAM COOK EUROPE·Product code DTK·October 27, 2015
OCTRODE
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·June 27, 2014
CURRENT PLUS DR, DF4 CONNECTOR
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·February 8, 2013
HERCULES 3 STAGE WIRE GUIDED BALLOON DILATOR
FDA Adverse Event
Malfunction
·COOK ENDOSCOPY·Product code KNQ·December 8, 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