• 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 film, radiographic
Regulation Description Radiographic film.
Product CodeIWZ
Regulation Number 892.1840
Device Class 1


Premarket Reviews
ManufacturerDecision
EASTMAN KODAK
  SUBSTANTIALLY EQUIVALENT 17

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 0 0 0 0 0 0 0 0
Class III 0 0 0 1 1 1 1 3 1 0

Recalls
Manufacturer Recall Class Date Posted
1 AGFA Corp. III Jun-26-2015
2 AGFA Corp. III Nov-25-2011
3 AGFA Healthcare Corp. III Dec-16-2014
4 AGFA Healthcare Corp. III Aug-10-2014
5 Carestream Health Inc. III Aug-01-2014
6 Carestream Health, Inc. III Jan-28-2013
7 Carestream Health, Inc. III Jan-13-2012
8 Carestream Health, Inc. III Apr-08-2010

-
-