10 results · 21ms · Sources: EU EUDAMED, US FDA

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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