11 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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VITA Multi-Function Head Brush (TB-2343F, TB-2442F)
FDA 510(k)
FDA Class 2
·Neurology
Flow sensor
FDA UDI
Hamilton Medical AG·07630002802857·Flow sensor for use with all HAMILTON ventilato...
VivaChek Ino Blood Glucose Monitoring System
FDA 510(k)
FDA Class 2
·Clinical Chemistry
BIO-RAY SDX DIGITAL X-RAY SYSTEM
FDA 510(k)
FDA Class 2
·Dental
BD VACUTAINER® K2 EDTA (K2E) 5.4MG BLOOD COLLECTION TUBES
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO (FRANKLIN LAKES)·Product code GIM·May 6, 2026
BD VACUTAINER® K2 EDTA (K2E) 5.4MG BLOOD COLLECTION TUBES
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO (FRANKLIN LAKES)·Product code GIM·May 6, 2026
Hamilton Medical Infant Flow Sensor, single use, (3.1m), Part number 260179. The infant flow sensor is an accessory for the Hamilton Medical Ventilators. Product Usage: The infant flow sensor is a device to measure patient air flow and pressures within the Hamilton Medical Ventilators.
FDA Enforcement
Class II
·Terminated·Hamilton Medical, Inc.·July 8, 2015
SENSOR ENLITE
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OZO·November 18, 2014
UNICEL DXC 800 SYNCHRON SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code JJE·August 26, 2011
CORTSCR Ø2 SELF-TAP L38 TAN
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HWC·August 1, 2013
Hamilton Medical Infant Flow Sensor, single use, (3.1m), Part number 260179. The infant flow sensor is an accessory for the Hamilton Medical Ventilators. Product Usage: The infant flow sensor is a device to measure patient air flow and pressures within the Hamilton Medical Ventilators.
FDA Recall
Terminated
·Hamilton Medical, Inc.·Product code BZO·June 1, 2015