12 results
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23ms
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Sources: EU EUDAMED, US FDA
JOSTRA HL-15 MODULAR HEART-LUNG MACHINE (HEREINAFTER CALLED THE HL-15 OR THE DEVICE
FDA 510(k)
FDA Class 2
·Cardiovascular
MAS PCF
FDA UDI
Nuvasive, Inc.·00887517651594·MAS PCF Screw, 4.5x20mm
ABL80 SC80
FDA UDI
Radiometer Medical ApS·05700699457202·SC80 100/30 Full-OX, no QC3
PALMAZ BILIARY STENT
FDA 510(k)
FDA Class 2
·Cardiovascular
ORTHO COUNT CALIBRATION KIT FOR ORTHO CYTORONABSOLUTE LASER FLOW CYTOMETRY SYSTEM
FDA 510(k)
FDA Class 2
·Hematology
INTERSTIM II
FDA Adverse Event
Injury
·NEURO - VILLALBA·Product code EZW·September 15, 2021
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·July 28, 2015
VERIFLEX¿
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - GALWAY·Product code MAF·February 6, 2013
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 21, 2014
INTERSTIM II
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·August 4, 2014
EVOLUT FX DCS
FDA Adverse Event
Malfunction
·MEDTRONIC IRELAND·Product code NPT·September 8, 2025
PKG, 5MM INSERT, ATRAUMATIC GRASPER FORCEPS, DOUBLE ACTION 45CM, P/N 0250080585 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