15 results
·
20ms
·
Sources: EU EUDAMED, US FDA
CHEMMATE(TM) UCHL1 (CD45-RO)
FDA 510(k)
FDA Class 2
·Immunology
APEX Revision Knee
FDA UDI
Omni Life Science, Inc.·00841690124788·Modular Stem 15mm x 125mm
Sierra
FDA UDI
Seaspine Orthopedics Corporation·10889981094645·Torque Limiting T-Handle, 35 IN-LB
PALM PRO PREMIUM, MODEL 6PF1 & PALM PRO, MODEL 6PF2, LATEX EXAM GLOVE
FDA 510(k)
FDA Class 1
·General Hospital
The Octane Straight Intervertebral Fusion Device, Ti Coated
FDA 510(k)
FDA Class 2
·Orthopedic
STOCKERT S3 LEVEL SENSOR MOUNTING PADS
FDA Adverse Event
Other
·SORIN GROUP DEUTSCHLAND·Product code DTW·August 2, 2012
SENSOR MODULE LEVEL/BUBBLE
FDA Adverse Event
Other
·SORIN GROUP DEUTSCHLAND·Product code DTW·May 11, 2012
ACCESSORIES
FDA Adverse Event
Malfunction
·ABBOTT VASCULAR INC.·Product code DQX·March 20, 2025
MENTOR TISSUE EXPANDER
FDA Adverse Event
Malfunction
·MENTOR CORPORATION·Product code LCJ·January 17, 2013
VASOVIEW 6 EVH SYSTEM
FDA Adverse Event
Malfunction
·MAQUET CARDIOVASCULAR, LLC·Product code GEI·December 9, 2010
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·July 22, 2014
STOCKERT S3 LEVEL SENSOR MOUNTING PADS
FDA Adverse Event
Other
·SORIN GROUP DEUTSCHLAND·Product code DWA·January 6, 2012
S5 BUBBLE DETECTOR SENSOR 3/16''
FDA Adverse Event
Malfunction
·LIVANOVA DEUTSCHLAND·Product code KRL·February 25, 2022
STOCKERT S3 LEVEL SENSOR MOUNTING PADS
FDA Adverse Event
Other
·SORIN GROUP DEUTSCHLAND·Product code DTW·January 6, 2012
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