16 results
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30ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BIOSIGN, ACCUSIGN, LIFESIGN, HCG SERUM/URINE
FDA 510(k)
FDA Class 2
·Clinical Chemistry
PANOSOL II UVA-218
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ALBUMIN BCP
FDA 510(k)
FDA Class 2
·Clinical Chemistry
MAINFRAME 8253001 NIM RESPONSE 3.0
FDA Adverse Event
Injury
·MEDTRONIC XOMED, INC·Product code ETN·November 7, 2013
NIM® EMG - ENDOTRACHEAL TUBE - TRIVANTAGE®
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED INC.·Product code ETN·June 3, 2015
MAINFRAME 8253001 NIM RESPONSE 3.0
FDA Adverse Event
Injury
·MEDTRONIC XOMED, INC·Product code ETN·December 16, 2013
TI CLICK'X LOCKING CAP FOR TI 3-D HEAD
FDA Adverse Event
Injury
·SYNTHES MONUMENT·Product code KWP·December 28, 2010
M2A-MAGNUM 42-50MM TAPER INSERT-6
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·February 5, 2013
COAGUCHEK® XS SYSTEM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code GJS·July 18, 2014
NIM® 3.0 MAINFRAME
FDA Adverse Event
Injury
·MEDTRONIC XOMED INC.·Product code ETN·January 14, 2015
Colonoscope, Model Number PCF-H190DL.
FDA Enforcement
Class II
·Ongoing·Olympus Corporation of the Americas·March 6, 2024
ENDOTRACH TUBE 8229507 CONTACT EMG 7MM
FDA Adverse Event
Injury
·MEDTRONIC XOMED, INC.·Product code ETN·January 7, 2014
NIM® EMG ELECTRODE
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED INC.·Product code GXZ·January 27, 2017
NIM® EMG - ENDOTRACHEAL TUBE - TRIVANTAGE®
FDA Adverse Event
Injury
·MEDTRONIC XOMED, INC·Product code ETN·July 1, 2016
NIM® EMG - ENDOTRACHEAL TUBE - TRIVANTAGE®
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED INC.·Product code ETN·December 8, 2016
NIM® EMG ELECTRODE
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED INC.·Product code GXZ·February 13, 2017