10 results
·
20ms
·
Sources: EU EUDAMED, US FDA
IMMUNOCAP THYRLOBULIN IMMUNOCAP
FDA 510(k)
FDA Class 2
·Immunology
A1CNOW FOR HOME USE
FDA 510(k)
FDA Class 2
·Hematology
HARDYDISK CEFOTETAN, 30MCG
FDA 510(k)
FDA Class 2
·Microbiology
CANNULATED PARTIALLY THREADED RECONSTRUCTIVE SCREW
FDA Adverse Event
Injury
·BIOMET·Product code HSB·March 13, 2012
PRECISION SPECTRA
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·September 5, 2023
VITEK 2 AST-P606 ANTIMICBROBIAL SUSCEPTIBILITY TEST KIT
FDA Adverse Event
Malfunction
·BIOMÉRIEUX, INC.·Product code LON·February 23, 2015
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·April 23, 2013
SPECTRA CONCEALABLE PENILE PROSTHESIS
FDA Adverse Event
Injury
·AMERICAN MEDICAL SYSTEMS, INC.·Product code FAE·April 21, 2011
TRANSVENE
FDA Adverse Event
Injury
·MEDTRONIC, INC.·Product code LWS·July 10, 2008
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