12 results · 22ms · Sources: EU EUDAMED, US FDA

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COULTER LIN-X LINEARITY CONTROL

FDA 510(k)
FDA Class 2 ·Hematology

Harvard Temp C&B Pro A1

FDA UDI
Harvard Dental International GmbH·EHAR70816411·Temporary crown and bridge material 4:1

PERCLOSE¿ PROSTYLE¿

FDA Adverse Event
Malfunction ·ABBOTT VASCULAR INC.·Product code MGB·November 26, 2025

XTD THROMBECTOMY CATHETER, XX CM

FDA 510(k)
FDA Class 2 ·Cardiovascular

TAMPONS

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM

FDA Adverse Event
Injury ·ABBOTT VASCULAR·Product code NIQ·March 12, 2020

XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM

FDA Adverse Event
Injury ·ABBOTT VASCULAR·Product code NIQ·February 12, 2021

ASR ACETABULAR IMPLANT 54

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL·Product code KWA·April 29, 2013

HEARTSTART MRX-EMS DEFIBRILLATOR

FDA Adverse Event
Death ·PHILIPS HEALTHCARE·Product code MKJ·April 26, 2011

ONE TOUCH ULTRA METER

FDA Adverse Event
Injury ·LIFESCAN, INC.·Product code NBW·July 22, 2008

Femoral Nail, A/R T2 Femur ¿10x320 mm, Product Number 18251032S

FDA Enforcement
Class II ·Terminated·Stryker GmbH·July 18, 2018

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