12 results · 18ms · Sources: EU EUDAMED, US FDA

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STRATUS N-ACETYLPROCAINAMIDE FLUOROMETRIC ENZYME I

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

NAR Kit

FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209120963·KIT, INDIVIDUAL FIRST AID - CUSTOM

SMARTPILL GI MONITORING SYSTEM

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

ECHELON Oval V 5.1 MRI System

FDA 510(k)
FDA Class 2 ·Radiology

MENTOR SMOOTH ROUND MODERATE PLUS PROFILE

FDA Adverse Event
Injury ·MENTOR TEXAS·Product code FWM·March 13, 2019

PINNACLE MTL INS NEUT36IDX62OD

FDA Adverse Event
Malfunction ·DEPUY ORTHOPAEDICS, INC. 1818910·Product code KWA·July 19, 2013

ARTICULEZE M HEAD 36MM +5

FDA Adverse Event
Malfunction ·DEPUY ORTHOPAEDICS, INC. 1818910·Product code JDI·July 19, 2013

ACUMATCH M-SERIES METAPHYSEAL

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code LPH·June 3, 2014

ENDOTAK RELIANCE

FDA Adverse Event
Injury ·CPI - DEL CARIBE·Product code NVY·October 5, 2010

UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEM

FDA Adverse Event
Malfunction ·BECKMAN COULTER, INC.·Product code JJE·December 3, 2012

MENTOR SMOOTH ROUND MODERATE PLUS PROFILE

FDA Adverse Event
Injury ·MENTOR TEXAS·Product code FWM·February 16, 2021

Acidified Concentrate Distribution and Storage-The Isopure ACDS (Acidified Concentrate Distribution and Storage) with remote fill is intended to be used in Hemodialysis facilities for the storage and distribution of acid concentrate to be used in the treatment of Hemodialysis patients Model: ACDS MD704262

FDA Enforcement
Class II ·Terminated·Isopure Corp·September 21, 2022