13 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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