• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
Device device, anti-snoring
Regulation Description Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea.
Product CodeLRK
Regulation Number 872.5570
Device Class 2


Premarket Reviews
ManufacturerDecision
AMERICAN ORTHODONTICS
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 2
NELLCOR PURITAN BENNETT
  SUBSTANTIALLY EQUIVALENT 2
RESPIRONICS, INC.
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Migration of device or device component 150
Extrusion 104
Product quality issue 10
No Known Device Problem 9
Implant extrusion 7
Delamination 7
Rejection 3
Break 3
Patient-device incompatibility 2
No code available 2
Device handling issue 1
Failure of device to self-test 1
Malposition of device 1
Device Cleaning Issue 1
Detachment of device component 1
Failure to deploy 1
Material fragmentation 1
Use of Device Issue 1
Improper or incorrect procedure or method 1
Total Device Problems 306

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 0 0
Class II 0 0 1 0 0 0 0 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Medtronic Xomed, Inc. II Dec-15-2009

-
-