10 results
·
19ms
·
Sources: EU EUDAMED, US FDA
CHEMMATE(TM) CD43
FDA 510(k)
FDA Class 2
·Immunology
Sierra
FDA UDI
Seaspine Orthopedics Corporation·10889981094607·Ratcheting Rod Cutter
Biodex
FDA UDI
SPORT MEDICAL TECHNOLOGY INC.·00718175001486·CYCLE, UPPER BODY - CLINICAL PRO
Terason uSmart3300 Ultrasound System
FDA 510(k)
FDA Class 2
·Radiology
MENTOR ARIS TRANS-OBTURATOR TAPE AND SURGICAL KIT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SYMBIQ SINGLE CHANNE
FDA Adverse Event
Malfunction
·HOSPIRA, INC.·Product code FRN·December 9, 2010
RIATA ACTIVE FIXATION
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·February 8, 2013
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·July 22, 2014
1820334-2020-01805
FDA Adverse Event
Malfunction
·COOK INC·Product code FOZ·October 5, 2020
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