11 results
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27ms
·
Sources: EU EUDAMED, US FDA
SCEPTOR SYSTEM PANELS
FDA 510(k)
FDA Class 2
·Microbiology
VARIAX
FDA UDI
Stryker GmbH·04546540540799·Inlay, 2.3M,2.3L Hand Compr. Plates
PRINCETON
FDA UDI
Princeton Medical Group, Inc.·00810158212558·SCISSOR PARAMETRIUM SOFT CURVE 9"
PRINCETON
FDA UDI
Princeton Medical Group, Inc.·00810158216617·FORCEPS DISIMPACTION ROWE CHILDREN LEFT 9.25"
Sierra
FDA UDI
Seaspine Orthopedics Corporation·10889981094362·Modular Handle
P-STIM SYSTEM
FDA 510(k)
FDA Unclassified
·Unknown
Master-Pin X (MP Pin with thread) (36BMP000030 / MP30)
FDA 510(k)
FDA Class 2
·Dental
RIATA ACTIVE FIXATION
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·February 8, 2013
ISPAN SULFUR HEXAFLUORIDE (SF6) GAS
FDA Adverse Event
Malfunction
·ALCON - FORT WORTH / ALCON LABORATORIES, INC.·Product code LPO·December 9, 2010
UNKNOWN PINNACLE CUP
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.1818910·Product code KWA·July 22, 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