14 results · 30ms · Sources: EU EUDAMED, US FDA

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TEXTURED POWDER FREE NITRILE EXAM GLOVES WITH SAP

FDA 510(k)
FDA Class 1 ·General Hospital

ADMIRA FLOW

FDA 510(k)
FDA Class 2 ·Dental

LUNAR REPORT GENERATOR II

FDA 510(k)
FDA Class 2 ·Radiology

SMARTMONITOR 2 PS

FDA Adverse Event
Malfunction ·PHILLIPS RESPIRONICS - CHMV·Product code FLS·February 21, 2014

SMART MONITOR 2 PS

FDA Adverse Event
Malfunction ·PHILIPS RESPIRONICS -CHMV·Product code NPF·August 26, 2014

ENDOTAK RELIANCE

FDA Adverse Event
Injury ·CPI - DEL CARIBE·Product code NVY·April 16, 2013

OT ULTRALINK METER

FDA Adverse Event
Malfunction ·LIFESCAN INC.·Product code NBW·April 18, 2011

LIFEPAK CR PLUS DEFIBRILLATOR

FDA Adverse Event
Malfunction ·PHYSIO-CONTROL, INC.·Product code MKJ·June 13, 2008

SMARTMONITOR 2 PROFESSIONAL SERIES

FDA Adverse Event
Malfunction ·PHILIPS RESPIRONICS - CHMV·Product code FLS·August 23, 2013

DIMENSION VISTA®

FDA Adverse Event
Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code MMI·August 28, 2018

SMART MONITOR 2 PS

FDA Adverse Event
Malfunction ·PHILIPS RESPIRONICS - CHMV·Product code NPF·May 30, 2013

SMART MONITOR 2 PS

FDA Adverse Event
Malfunction ·PHILIPS RESPIRONICS - CHMV·Product code NPF·September 4, 2013

SMART MONITOR 2 PS

FDA Adverse Event
Malfunction ·PHILIPS RESPIRONICS - CHMV·Product code NPF·October 11, 2013

CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.

FDA Enforcement
Class II ·Terminated·Smiths Medical ASD, Inc.·June 24, 2015