11 results · 27ms · Sources: EU EUDAMED, US FDA

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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