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

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EMIT 2000 VALPROIC ACID ASSAY, MODEL OSR4G229UL

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

Henry Schein

FDA UDI
HENRY SCHEIN, INC.·00304040012864·Zirlux 16+ B4 95X30

G-aenial™ Bond

FDA UDI
Gc America Inc.·14548161296526·G-aenial™ Bond (1 x 5 mL bottle) Refill

G-aenial™ Bond

FDA UDI
Gc America Inc.·D0470119471·G-aenial™ Bond (1 x 5 mL bottle) Refill

T.I.M.S., VERSION 2.00

FDA 510(k)
FDA Class 2 ·Radiology

SNOW LOTUS POWDER FREE LATEX EXAMINATION GLOVES WITH A PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)

FDA 510(k)
FDA Class 1 ·General Hospital

HOMECHOICE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·March 19, 2013

BRAVO

FDA Adverse Event
Malfunction ·GIVEN IMAGING LTD.·Product code FFT·February 10, 2011

LIFEPAK 20 DEFIBRILLATOR/MONITOR

FDA Adverse Event
Malfunction ·PHYSIO-CONTROL, INC.·Product code LDD·March 11, 2008

5ML BD POSIFLUSH¿ HEPARIN LOCK FLUSH SYRINGE, IN 10ML SYRINGE, 10 USP UNITS/ML

FDA Adverse Event
Death ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FOZ·July 12, 2018

UUltrasound System 2300, bkActiv w/battery; Model No. 2300-11; System, Imaging, Pulsed Doppler, Ultrasonic

FDA Enforcement
Class II ·Ongoing·B-K Medical A/S·November 12, 2025

Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.

FDA Enforcement
Class II ·Terminated·Belmont Instrument Corporation·October 24, 2012

Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.

FDA Enforcement
Class II ·Terminated·St Jude Medical Cardiac Rhythm Management Division·September 10, 2014