8 results
·
19ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
DENE BRIDGE
FDA 510(k)
FDA Class 2
·Dental
Brigade
FDA UDI
Nuvasive, Inc.·00887517964830·Brigade Lateral Trial, 15x38x32mm 12°
AEGIS NAVIGATION ANDA EGIS PELVIC APPLICATION
FDA 510(k)
FDA Class 2
·Radiology
MEDGE PLATFORMS SONOCUBIC 3D ULTRASOUND SOFTWARE
FDA 510(k)
FDA Class 2
·Radiology
UNIFY CRT-D
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code NIK·June 30, 2014
HEMOVAC BLOOD REINFUSION SYSTEM 3/16
FDA Adverse Event
Malfunction
·ZIMMER SURGICAL·Product code CAC·January 4, 2013
ACCU-CHEK ® AVIVA TEST STRIPS
FDA Adverse Event
Injury
·ROCHE DIAGNOSTICS·Product code LFR·November 20, 2010
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