Film, Radiographic
Regulation 892.1840
0510(k)s in 12 months (34 all time)
0recalls in 12 months (13 all time)
0recalls that name a 510(k)
Top companies in IWZ
| Company | 510(k)s | Recalls |
|---|---|---|
| Eastman Kodak Company | 17 | 0 |
| Carestream Health Inc. | 0 | 6 |
| Cea America Corp. | 4 | 0 |
| AGFA Corp. | 0 | 3 |
| 3M Health Care, Ltd. | 2 | 0 |
| AGFA Healthcare Corp. | 0 | 2 |
| E.I. Dupont DE Nemours & Co., Inc. | 2 | 0 |
| Agfa N.V. | 0 | 1 |
| Belmont Equipment Corp. | 1 | 0 |
| Burkhart Roentgen Intl., Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 25, 2019 | Agfa N.V. PET Plates Coated Film-MONOMEDBV2S2- Radiographic Film
REF:
XJUB8, XJM73, XJUDD, XJM85, EKLYZ. Product Usage: Due to an inhomogeneous coating solution, pinholes can become visible in even dark im Terminated |
IWZ | None listed |
| Dec 16, 2014 | AGFA Healthcare Corp. Radiomat M+ NIF 14 x 17, Radiomat M+ NIF 35CM x 43CM, Radiomat M+ NIF 10 x 12, Radiomat M+ NIF 25,4CM x 30,5CM Terminated |
IWZ | None listed |
| Aug 10, 2014 | AGFA Healthcare Corp. Radiomat M+ NIF 14 x 17; Radiomat SG 14 x 17 NIF; RX-B 8 x 10 in./IBF-004355; Radiomat B+ NIF 14 x 17; Radiomat B+ NIF 8 x 10; Radiomat B+ NIF 9 1/2 x 9 1/2; CX Ultra UV-G Plus NIF 11 x 14; Radiomat G Terminated |
IWZ | None listed |
| Aug 1, 2014 | Carestream Health Inc. Ultra-speed Dental Film, Catalog Number/REF 834 8658, KODAK and Carestream DENTAL labels --- Carestream Health Inc. Terminated |
IWZ | None listed |
| Aug 1, 2014 | Carestream Health Inc. INSIGHT Dental Film, Catalog Number/REF 811 0785, KODAK and Carestream DENTAL labels --- Carestream Health Inc. Terminated |
IWZ | None listed |
| Jan 28, 2013 | Carestream Health, Inc. KODAK INSIGHT DENTAL FILM in SureSoft Packets, Size 2 Single Packet Film, Model Number IP21S, REF/Catalog Number 8118226 --- COMMON/USUAL NAME: Dental Intraoral Radiographic Film -- 20 cartons of 80 Terminated |
IWZ | None listed |
| Jan 13, 2012 | Carestream Health, Inc. DVB KODAK DRYVIEW --- 35x43 cm --- 125 SHT --- REF 8723132 --- Made in U.S.A. by Carestream Health, Inc., 150 Verona St, Rochester, New York 14608.
General purpose radiography. Terminated |
IWZ | None listed |
| Nov 25, 2011 | AGFA Corp. Curix Opthos H, size 35x43 cm
A radiographic medical x-ray film designed to optimize diagnostic chest imaging by providing complete diagnostic information including superbly visualized lung detail al Terminated |
IWZ | None listed |
| Apr 8, 2010 | Carestream Health, Inc. KODAK T-MAT G/RA Film, Catalog/REF # 151 0023, 24x30 cm, 5-100 Sheet Boxes FOLHAS/Hojas, Made in U.S.A. by Carestream Health, Inc. 150 Verona Street, Rochester, NY 14608 --- Device Listing # E420904
Terminated |
IWZ | None listed |
| Apr 8, 2010 | Carestream Health, Inc. KODAK T-MAT L/RA Film, Catalog/REF # 181 4631, 35x43 cm 5-100 Sheet Boxes Folhas/Hojas, Made in U.S.A. by Carestream Health, Inc. 150 Verona Street, Rochester, NY 14608 --- Device Listing # E420904
Terminated |
IWZ | None listed |
| Mar 2, 2010 | AGFA Corp. Drystar Mammo.
Display of Mammographic images. Terminated |
IWZ | None listed |
| Apr 22, 2006 | AGFA Corp. Mamoray HDR-C PLUS Mammography film Terminated |
IWZ | None listed |
| Jul 20, 2004 | Konica Medical Imaging, Inc. Konica Minolta Duplicating Film Emulsions. Konica Medical Film. Emulsion numbers X(=any number), X 742, X842, X152. Film type SR-DUP 8x10, 10x12, 11x14, and 14x17. Film type PPD DUP 10x12 only and Terminated |
IWZ | None listed |
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