8 results
·
27ms
·
Sources: EU EUDAMED, US FDA
IMMUNALYSIS METHAMPHETAMINE ELISA FOR ORAL FLUIDS
FDA 510(k)
FDA Class 2
·Clinical Toxicology
OCU-FLEX 55 SPHERICAL, TORIC,THIN ZONE TORIC,ASPHERICAL,TORIC ASPHERICAL AND THIN ZONE TORIC ASPHERICAL (METHAFILCON A)S
FDA 510(k)
FDA Class 2
·Ophthalmic
OUTBACK CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
BACT/ALERT® FN PLUS
FDA Adverse Event
Malfunction
·BIOMERIEUX INC.·Product code MDB·March 12, 2019
DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE
FDA Adverse Event
Injury
·MPRI·Product code NVN·April 10, 2013
COBAS 6000 C501 MODULE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code CEM·May 19, 2008
CAPSURE Z NOVUS
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·April 12, 2011
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