13 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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A1-CS-SB Y-ADAPTER, MODEL 124 871
FDA 510(k)
FDA Class 2
·Cardiovascular
SCANLAN® Needle Holders
FDA UDI
SCANLAN INTERNATIONAL INC·00846159003390·Richards Micro Needle Holder
DIMEX 2
FDA 510(k)
FDA Class 2
·Dental
SILVERSPEED HYDROPHILIC GUIDEWIRE (0.014 DIAMETER, 145CM LENGTH, SUPPORT) SILVERSPEED HYDROPHILIC GUIDEWIRE (0.014 D
FDA 510(k)
FDA Class 2
·Cardiovascular
HAND PIECE FOR BATTERY POWERED DRIVER
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code GZL·August 14, 2013
SMALL BATTERY DRIVE
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code HWE·August 5, 2015
BIVONA UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD, INC.·Product code JOH·February 11, 2013
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·March 1, 2011
COMPLETE MOISTUREPLUS
FDA Adverse Event
Injury
·AMO ADVANCED MEDICAL OPTICS·Product code LPN·February 24, 2008
NIM® EMG - ENDOTRACHEAL TUBE - TRIVANTAGE®
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED INC.·Product code ETN·October 19, 2015
smiths medical portex Venn Reusable Tracheal Tube Introducer, 15Ch x 60cm, REF 14-504-17 and REF 14-504-17JP
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD, Inc.·December 4, 2024
STERRAD 100NX Sterilization System, P/N 10104 Product Usage: The STERRAD 100NX Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD 100NX process to inactivate microorganisms on a board range of medical devices and surgical instruments.
FDA Enforcement
Class II
·Terminated·Advanced Sterilization Products·April 10, 2013
Covideien McGRATH MAC Video Laryngoscope, REF: 301-000-000, Non-Sterile, RxOnly
FDA Enforcement
Class II
·Ongoing·Covidien·August 28, 2024