7 results
·
26ms
·
Sources: EU EUDAMED, US FDA
IL GENTAMICIN ASSAY SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Toxicology
CONCORDE CURVE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
SYNTHES MODIFIED BIORESORBABLE SUTURE ANCHOR SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
COATED VICRYL (POLYGLACTIN 910) SUTURE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code GAM·January 9, 2013
ACCU-CHEK ® AVIVA TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·November 20, 2010
QUADRA ASSURA CRT-D, DF-4 CONNECTOR
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC., CRMD·Product code NIK·June 30, 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