12 results
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18ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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HUMAN C-5 RADIAL IMMUNODIFFUSION KIT
FDA 510(k)
FDA Class 2
·Immunology
BASE
FDA UDI
Nuvasive, Inc.·00887517700223·BASE Guide, Single B
RESORBABLE BONE SCREW
FDA UDI
Biomet Orthopedics, LLC·00880304416659·
Peerless Buccal Tube
FDA UDI
ORMCO CORPORATION·00889989022858·CAST 10DEG UFM CONV B/T-10TX018 045LT
Sierra
FDA UDI
Seaspine Orthopedics Corporation·10889981094164·4.0mm Tap, Short
Prophy Brush
FDA UDI
DiaDent Group International·08806383525749·A non-sterile rotary dental instrument with nat...
SnoreSounds
FDA 510(k)
FDA Class 2
·Anesthesiology
E-Z PEN, REUSEABLE HANDSWITCHING PENCIL
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
RIATA PASSIVE FIXATION
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·February 8, 2013
NEXGEN ROTATING HINGLE KNEE SCREW DRIVER
FDA Adverse Event
Malfunction
·ZIMMER, INC.·Product code HXX·December 7, 2010
STERLING?
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code DQY·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