18 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Epiduroscopy Introducer Set
FDA UDI
MYELOTEC, INC.·M79340075·
Video Guided Catheter
FDA UDI
MYELOTEC, INC.·M79320105·3.0 Video Guided Catheter
Video Guided Catheter
FDA UDI
MYELOTEC, INC.·M79320335·Video Guided Catheter
Epiduroscopy Introducer Set
FDA UDI
MYELOTEC, INC.·M79340085·Epiduroscopy Introducer Set
NaviCath
FDA UDI
MYELOTEC, INC.·M79320175·NaviCath Steerable Catheter Kit
VIDEO GUIDED CATHETER
FDA Adverse Event
Other
·MYELOTEC, INC.·Product code HRX·February 15, 2011
ARTHROSCOPE
FDA Adverse Event
Injury
·MYELOTEC, INC.·Product code HRX·October 31, 2014
VIDEO GUIDED CATHETER
FDA Adverse Event
Injury
·MYELOTEC, INC.·Product code HRX·December 7, 2012
2017 NAVICATH KIT
FDA Adverse Event
Injury
·MYELOTEC, INC.·Product code HRX·December 30, 2013
MYELOTEC SPINAL ENDOSCOPY ACCESS KIT
FDA Adverse Event
Malfunction
·MYELOTEC, INC.·Product code HRX·June 11, 2013
UNK
FDA Adverse Event
Injury
·MYELOTEC, INC.·Product code HRX·July 11, 2012
2010 VIDEO GUIDED CATHETER
FDA Adverse Event
Malfunction
·MYELOTEC, INC·Product code HRX·April 13, 2017
2017 NAVICATH KIT
FDA Adverse Event
Malfunction
·MYELOTEC, INC·Product code HRX·April 13, 2017
MYELOTEC NAVICATH STEERABLE EPIDURAL CATHETER
FDA Adverse Event
Other
·MYELOTEC, INC.·Product code BSO·January 11, 2008
Myelotec Video Guided Catheters, REF 2010 3.0 mm OD x 30 Cm Working Length, Two 1.3mm Working Channels
FDA Enforcement
Class II
·Ongoing·Myelotec, Inc.·August 9, 2017
Myelotec Steerable Video Guided Catheter, 3.0mm, Label Insert contained in LB0020-0, LB0020-1, LB0020-2, LB0020-3, and LB0020-4 (Product Code: 2010). Myelotech, Roswell, GA 30076.
FDA Recall
Terminated
·Myelotec, Inc.·Product code HRX·December 19, 2007
Myelotec Video Guided Catheters, REF 2010 3.0 mm OD x 30 Cm Working Length, Two 1.3mm Working Channels
FDA Recall
Open, Classified
·Myelotec, Inc.·Product code HRX·March 2, 2017
Myelotec Steerable Video Guided Catheter, 2.7mm, label insert for LB0013-1, LB0013-2, and LB0013-3. (product code: 2000) Myelotech, Roswell, GA 30076.
FDA Recall
Terminated
·Myelotec, Inc.·Product code HRX·December 19, 2007