Home › Device types › IWZ
Film, Radiographic
FDA product code IWZ · Class 1 · Radiology
951
Registered devices
13
Adverse events
13
Recalls
34
510(k) clearances
Devices with this code
Ortho CP-GU M — AGFADRYVIEW DVC Laser Imaging Film — CARESTREAM HEALTH, INC.T-MAT G/RA Film — CARESTREAM HEALTH, INC.Minimax Panoramic B 6X12 — Flow X Ray CorporationCLINICSELECT Green Latitude X-ray Film — CARESTREAM HEALTH, INC.X-OMAT DBF — CARESTREAM HEALTH, INC.CLINICSELECT Half-Speed Blue X-ray Film — CARESTREAM HEALTH, INC.Gafchromic™ — ASHLAND SPECIALTY INGREDIENTS G.P.EB/RA Film — CARESTREAM HEALTH, INC.FILM INTRAORAL X-RAY — Flow X Ray CorporationSafco X-Pose intraoral x-ray film — SAFCO DENTAL SUPPLY CO.EB/RA Film — CARESTREAM HEALTH, INC.T-MAT L/RA Film — CARESTREAM HEALTH, INC.Rad Control — TYPENEX MEDICAL LLCFUJI MEDICAL X-RAY FILM — FUJIFILM CORPORATIONOrtho CP-GU M — AGFAT-MAT L/RA Film — CARESTREAM HEALTH, INC.Oncology EDR2 Film — CARESTREAM HEALTH, INC.Quala — NATIONAL DISTRIBUTION & CONTRACTING, INC.DRYVIEW DVB Laser Imaging Film — CARESTREAM HEALTH, INC.Gafchromic™ — ASHLAND SPECIALTY INGREDIENTS G.P.CP-BU M — AGFAFILM DSS-58 D ADULT SINGLE FILM BUTTERFLY PACKETS D SPEED — Flow X Ray CorporationGafchromic™ — ASHLAND SPECIALTY INGREDIENTS G.P.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2019-01-25 | Agfa N.V. | Due to an inhomogeneous coating solution, pinholes can become visible in even dark images. Visibility of the pinholes varies as material from this coating run s |
| 2014-10-24 | AGFA Healthcare Corp. | Some material of the coating Type CXCPMV3 has potential artifacts showing a small bright thin line when the film is processed. |
| 2014-07-16 | AGFA Healthcare Corp. | Some sheets of the medical screen film are fogged. |
| 2014-07-02 | Carestream Health Inc. | The Indicator Dot on the film packet's outer printed paper labeling was incorrectly positioned relative to the location of the raised dot on the dental intraora |
| 2014-07-02 | Carestream Health Inc. | The Indicator Dot on the film packet's outer printed paper labeling was incorrectly positioned relative to the location of the raised dot on the dental intraora |
| 2013-01-17 | Carestream Health, Inc. | Missing symbols and manufacturing information on the clear carton label. The expiration dating symbol is missing but the expiration date is not missing. The L |
| 2011-12-20 | Carestream Health, Inc. | Kodak DryView DVB Film is being recalled because it does not meet the specification for maximum density. |
| 2011-10-04 | AGFA Corp. | The film notch was located in the wrong position. |
| 2010-03-12 | Carestream Health, Inc. | Product mix-up. The firm received a customer complaint indicating that the customer had opened a box of film and although it was supposed to be T-MAT L/RA, it |
| 2010-03-12 | Carestream Health, Inc. | Product mix-up. The firm received a customer complaint indicating that the customer had opened a box of film and although it was supposed to be T-MAT L/RA, it |
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