12 results
·
27ms
·
Sources: EU EUDAMED, US FDA
VITROS CHEMISTRY PRODUCTS URCR SLIDES, VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT, MODEL 680 2722, 195 7927
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Sklar®
FDA UDI
SKLAR CORPORATION·10649111090677·MILLER ENG-STYLE STAND SIZE 3
DBEST HCG 2 IU/ML TEST KIT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
BIO-LOGIC ABAER CUB
FDA 510(k)
FDA Class 2
·Neurology
WAVEWRITER ALPHA
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·December 26, 2022
CELL-DYN DILUENT/SHEATH
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS DIVISION/CELLDYN·Product code GKL·January 5, 2007
ULTRACISION HARMONIC ACE
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code LFL·April 22, 2013
NONE
FDA Adverse Event
Death
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·June 27, 2008
CAPSURE EPI
FDA Adverse Event
Injury
·MEDTRONIC, INC.·Product code DTB·April 27, 2011
CELL-DYN RUBY SYSTEM
FDA Adverse Event
Malfunction
·ABBOTT LABORATORIES·Product code GKZ·November 10, 2023
ADVIA CENTAUR XP FOLATE (FOL) ASSAY
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code CGN·January 9, 2014
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012