10 results
·
21ms
·
Sources: EU EUDAMED, US FDA
ELVI 828 DIGICLOT MULTISCAN
FDA 510(k)
FDA Class 2
·Hematology
SureStep™ Foley Tray System Bard®Lubricath® Foley Catheter
FDA UDI
C. R. Bard, Inc.·00801741104626·SureStep® Foley Tray System
Bard Lubricath Fole...
ALLthread Titanium
FDA UDI
Biomet Orthopedics, LLC·00880304464315·
ADVENT IMPLANT SYSTEM
FDA 510(k)
FDA Class 2
·Dental
X-SMART EASY
FDA 510(k)
FDA Class 1
·Dental
HEMOPRO2 EXTENSION CABLE
FDA Adverse Event
Malfunction
·MAQUET CARDIOVASCULAR, LLC·Product code GEI·May 9, 2014
CYPHER SIROLIMUS-ELUTING CORONARY STENT
FDA Adverse Event
Injury
·CORDIS LLC (PR)·Product code NIQ·November 18, 2010
RIATA PASSIVE FIXATION
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·January 8, 2013
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