12 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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3MATIC
FDA 510(k)
FDA Class 2
·Radiology
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·10304040064679·MOLAR BAND UR 1ST&2ND 41 (2)
N.A.
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR20609501·Arch wires Titanol Budget mand. .020"
Klitec Universal Instruments
FDA UDI
Kalitec Direct LLC·B07301K0603500·Tray, Base, 3.5"
Kalitec Universal Instruments
FDA UDI
Kalitec Direct LLC·B07301K0604500·Tray, Base, 4.5"
EMBRYO TRANSFER CATHETER SET, MODEL 320200 AND 320201
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
CYPRESS SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·April 16, 2013
RESTORE ULTRA
FDA Adverse Event
Malfunction
·MEDTRONIC NEUROMODULATION·Product code LGW·March 14, 2011
SPACEMAKER PREPERITONEAL DIST BALLOON
FDA Adverse Event
Malfunction
·PONCE - USS·Product code GCJ·June 13, 2008
SureT G29 6mm, 18", Paradigm; SureT G29 6mm 23"; SureT G29 6mm, 23", Paradigm; SureT G29 6mm 32"' SureT G29 6mm, 32", Paradigm; SureT G29 8mm, 23"; SureT G29 8mm, 23", Paradigm; SureT G29 8mm, 32"; SureT G29 8mm, 32", Paradigm; SureT G29 10mm, 32", Paradigm The products are used in combination with insulin infusion pumps for continuous subcutaneous infusion of insulin
FDA Enforcement
Class II
·Terminated·Unomedical As·November 9, 2016
Sure T, contact, contact detach, neria, neria detach, neria multi and thalaset Used in combination with infusion pumps for continuous subcutaneous infusion of medication.
FDA Enforcement
Class II
·Terminated·Unomedical As·July 1, 2015