9 results
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19ms
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Sources: EU EUDAMED, US FDA
FUKUDA SANGYO MODEL SPIROANALYZER ST-180
FDA 510(k)
FDA Class 2
·Anesthesiology
18" (46 CM) APPX 2.5 ML, EXT SET W/PRE-PIERCED PORT, EASYDROP FLOW CONTROLLER, R
FDA Adverse Event
Malfunction
·ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.·Product code FMG·December 16, 2022
Imbibe Aspirating XIA Taps
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
DIMENSION RXL MAX WITH STREAMLAB ANALYTICAL WORKCELL AND SAMPLE TRANSFER MODULE
FDA 510(k)
FDA Class 1
·Clinical Chemistry
840 VENTILATOR
FDA Adverse Event
Malfunction
·COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT IRELAND·Product code CBK·April 30, 2014
ACRYSOF RESTOR
FDA Adverse Event
Other
·ALCON RESEARCH, LTD./HUNTINGTON·Product code MFK·December 3, 2010
2.7MM CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 14MM
FDA Adverse Event
Injury
·SYNTHES MONUMENT·Product code HWC·February 5, 2013
1.85MM TI MATRIX SCREW SELF-TAPPING/4MM
FDA Adverse Event
Malfunction
·SYNTHES (USA)·Product code JEY·January 21, 2015
PKG., 3MM INSERT, BABCOCK FORCEPS, 29CM, P/N 0250282103 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.
FDA Enforcement
Class II
·Terminated·Stryker Endoscopy·December 24, 2014