8 results
·
17ms
·
Sources: EU EUDAMED, US FDA
BODYLOG ENHANCED STRESS REDUCTION PACKAGE
FDA 510(k)
FDA Class 2
·Neurology
GENUA MENOPAUSE MONITOR TEST KIT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
HUMAN IGD KIT FOR USE ON SPAPLUS
FDA 510(k)
FDA Class 2
·Immunology
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 6, 2014
TI MATRIX LOCKING CAP
FDA Adverse Event
Injury
·SYNTHES BRANDYWINE·Product code NKB·January 8, 2013
POWER PRO AMBULANCE COT
FDA Adverse Event
Malfunction
·STRYKER CORP., MEDICAL DIV.·Product code INK·November 12, 2010
DxI 600 Access Immunoassay Analyzer W/Spot B, Part Number A71460
FDA Enforcement
Class II
·Ongoing·Beckman Coulter, Inc.·August 13, 2025
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