9 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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LIQUID ALKALINE PHOSHATASE REAGENT SET
FDA 510(k)
FDA Class 2
·Clinical Chemistry
GC MODELS OPA-100 AND JC-50
FDA 510(k)
FDA Class 2
·Dental
Illumeo System
FDA 510(k)
FDA Class 2
·Radiology
RESOLUTE INTEGRITY RX
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code NIQ·February 22, 2013
ALLEGRETTO WAVE EYE-Q
FDA Adverse Event
Malfunction
·WAVELIGHT GMBH·Product code LZS·January 19, 2011
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·August 1, 2014
IO FiX X-Post Reamer, Extremity Medical, www.extremitymedical.com; Customer Service: 888.499.0079 The X-Post Reamer is an accessory to the IO FiX Screw and Washer System that is used for reaming bone most common to orthopedic surgical procedures.
FDA Recall
Terminated
·Extremity Medical LLC·Product code HTO·April 25, 2011
Extremity Medical - Disposable Orthopedic Surgical Instrument - 1.6 mm Guidewire - Reference Number 101-00006 - Non-Sterile. Contained in Extremity Medical Surgical Kits including CompressX, Hallu.X, IO Fix and XMCP. Used in the selection of screw size when used with appropriate depth gauge.
FDA Recall
Terminated
·Extremity Medical LLC·Product code HXI·January 10, 2013
Extremity Medical, IO FiX System Accessory. Catalog Number 101-00010. This screw measuring device is an accessory to the IO FiX Screw and Washer System that is used to measure the length of the screw by placing the depth gauge over the guidewire and down to the bone. Orthopedic device.
FDA Recall
Terminated
·Extremity Medical LLC·Product code HWC·March 22, 2012