28 results
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18ms
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Sources: EU EUDAMED, US FDA
CELLTRACKA ANALYZER II
FDA 510(k)
FDA Class 2
·Immunology
CELLTRACKS ANALYZER II¿ (Product Code 9555) Product Usage: The CELLTRACKS ANALYZER II¿ is a semi-automated fluorescence microscope, consisting of the analyzer, a dedicated computer with CELLTRACKS¿ software, monitor, keyboard, mouse and uninterruptible power supply (UPS). The system also supports an optional Remote Review Workstation (RRW), which consists of a dedicated computer with CELLTRACKS¿ software, monitor, keyboard and mouse. Use of this product requires training and should be used under the supervision of laboratory management. The CELLTRACKS ANALYZER II¿ is for analysis of rare cells that are isolated from biological fluids including whole blood. It is used in conjunction with the CELLTRACKS¿ AUTOPREP¿ System, which automates and standardizes the sample preparation with specific reagent kits. An optional Remote Review Workstation is also available to provide the capability to review images and report results remotely.
FDA Enforcement
Class II
·Terminated·Veridex, LLC·March 19, 2014
Asst Tabletop Cart
FDA UDI
Engle Dental Systems, LLC·00850043433132·AS-1 Assistant's cart with table top
TruForm
FDA UDI
Rmo, Inc.·00885797099655·MAN 1ST MOLAR RT< 100 BANDS
MedGyn Pessary Gehrung w/ support # 0
FDA UDI
MEDGYN PRODUCTS, INC.·M803050145·Gehrung Pessary is used to treat uterine prola...
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690117513·Distal Reamer (Hudson)
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690192633·Distal Reamer (Hudson)
ORTHOPAEDIC INNOVATIONS RENEWAL ACETABULAR CUP SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
MIDAS TOUCH BLUE NITRILE EXAMINATION GLOVES-POWDER FREE
FDA 510(k)
FDA Class 1
·General Hospital
BD PHOENIX¿ SMIC-101
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·February 13, 2026
DEPUY PINNACLE 300 ACETABULAR CUP METAL-ON-METAL HIP IMPLANT
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC·Product code KWA·March 15, 2013
CARPENTIER-EDWARDS PERIMOUNT MAGNA AORTIC BIOPROSTHESIS
FDA Adverse Event
Death
·EDWARDS LIFESCIENCES·Product code LWR·May 19, 2008
STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC.·Product code HAW·April 1, 2011
BD PHOENIX¿ SMIC/ID-101
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·October 16, 2024
BD PHOENIX¿ SMIC/ID-101
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·July 1, 2024
BD PHOENIX SMIC/ID-101
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code LON·May 6, 2021
BD PHOENIX¿ SMIC-101
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·July 28, 2025
BD PHOENIX¿ SMIC-101
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·July 28, 2025
BD PHOENIX¿ SMIC-101
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·July 28, 2025
BD PHOENIX¿ SMIC/ID-101
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·November 8, 2024