11 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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OLYMPUS KD-6G1-9Q WIRE GUIDED PAPILLOTOMU KNIFE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SIC invent Dental Implant Systems
FDA UDI
SIC invent AG·ESIC9501661·SICvantage max Screw Implant Ø 3.0 mm / 14.5 mm...
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471123168·K-WIRE - SINGLE TROCAR THREADED 1.6mm DIA x 150mm
PICCOLO BASIC METABOLIC PANEL
FDA Adverse Event
Malfunction
·ABAXIS, INC.·Product code CGX·October 22, 2020
PICCOLO COMPREHENSIVE METABOLIC PANEL
FDA Adverse Event
Malfunction
·ABAXIS, INC.·Product code CGX·November 3, 2020
Extremity Medical Suture Anchor
FDA 510(k)
FDA Class 2
·Orthopedic
PORTEX EMERGENCY CRICOTHYROIDOTOMY KIT
FDA 510(k)
FDA Class 2
·Anesthesiology
RIATA ACTIVE FIXATION
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·February 8, 2013
INFINITI VISION SYSTEM OZIL
FDA Adverse Event
Malfunction
·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·December 9, 2010
EON MINI
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·June 27, 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