8 results
·
27ms
·
Sources: EU EUDAMED, US FDA
HUMID-VENT 1
FDA 510(k)
FDA Class 1
·Anesthesiology
VISI-SWAB OPHTALMIC SPONGE
FDA 510(k)
FDA Class 2
·Ophthalmic
TEGADERM PLUS TRANSPARENT DRESSING #952X
FDA 510(k)
FDA Unclassified
·Unknown
ULTRACISION HARMONIC ACE
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code LFL·July 11, 2016
MAXIMO II CRT-D
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NIK·February 9, 2013
5.5MM TI CURVED ROD 65MM
FDA Adverse Event
Injury
·SYNTHES MEZZOVICO·Product code NKB·July 23, 2014
ENDOTAK RELIANCE
FDA Adverse Event
Malfunction
·CPI - DEL CARIBE·Product code NVY·January 7, 2011
Synthes Matrix 5.5.mm Left and Right Coronal Bender Product Usage: The Matrix 5.5.mm Left and Right Coronal Bender are used together to bend the 5.5 Matrix Rods in the coronal plane, and is intended for stabilization of the thoracic, lumbar, sacral, and/or iliac spine through screw and/or hook and rod fixation.
FDA Enforcement
Class II
·Terminated·Synthes USA HQ, Inc.·December 4, 2013