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 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 4, 1997 | K970154 | KODAK EKTASIAN HG FILM (EHG-15) Eastman Kodak Company | IWZ |
| Sep 29, 1995 | K954200 | VOXGRAM Voxel | IWZ |
| Jul 21, 1993 | K931604 | 3M MEDICAL DIAGNOSTIC VIDEOCASSETTE 3M Health Care, Ltd. | IWZ |
| Jul 20, 1993 | K931605 | 3M MEDICAL DIAGNOSTIC SUPER VHS VIDEOCASSETTE 3M Health Care, Ltd. | IWZ |
| Jun 30, 1992 | K920539 | ORWO X-RAY FILM Burkhart Roentgen Intl., Inc. | IWZ |
| Jan 30, 1989 | K884827 | KODAK DENTAL BARRIER PAC Eastman Kodak Company | IWZ |
| Aug 12, 1986 | K862944 | KODAK CFT FILM SO-141 Eastman Kodak Company | IWZ |
| Jul 1, 1986 | K862415 | TYPE 633 COMPUTED RADIOGRAPHY (CR) FILM Parexel Intl. Corp. | IWZ |
| Mar 13, 1986 | K860797 | MEDICAL X-RAY FILM India-America Trading Co. | IWZ |
| Feb 21, 1985 | K844554 | BELMONT AUTOPAN-PANORAMIC 098 CEPHALOMETRIC-RADIOG Belmont Equipment Corp. | IWZ |
| Apr 24, 1984 | K840806 | FR MEDICAL X-RAY FILM Fr Medical/Fr Chemicals | IWZ |
| Mar 16, 1984 | K840698 | POWERMAT VRP-1 X-RAY IMAGING Powers Chemco, Inc. | IWZ |
| Mar 5, 1984 | K834614 | WILCOR-XR RP-L MEDICAL FILM Cea America Corp. | IWZ |
| Mar 5, 1984 | K834613 | WILCOR-XR RP MEDICAL FILM Cea America Corp. | IWZ |
| Feb 27, 1984 | K834612 | WILCOR-XR RP-OG MEDICAL FILM Cea America Corp. | IWZ |
| Feb 21, 1984 | K834611 | SINGUL-XR RP NON SCREEN MED. FILM Cea America Corp. | IWZ |
| Oct 28, 1983 | K833234 | KODAK T-MAT L FILM SO-387 Eastman Kodak Company | IWZ |
| Sep 12, 1983 | K832504 | CRONEX LO-DOSE MAMMOGRAPHY E.I. Dupont DE Nemours & Co., Inc. | IWZ |
| Nov 24, 1981 | K813005 | KODAK CINEFLUOROGRAPHIC FILM SO-274 Eastman Kodak Company | IWZ |
| Jun 18, 1981 | K811352 | POLAROID TPX RADIOGRAPHIC FILM Polaroid Corp. | IWZ |
| Oct 31, 1980 | K802171 | KODAK ORTHO L FILM Eastman Kodak Company | IWZ |
| May 20, 1980 | K800901 | KODAK EKTASPEED DENTAL X-RAY FILM Eastman Kodak Company | IWZ |
| May 2, 1980 | K800134 | HOPE MODEL 126, AUTO/PROCES., DEN. FLM Hope Industries, Inc. | IWZ |
| Jan 9, 1980 | K792517 | KODAK X-OMAT RP FILM Eastman Kodak Company | IWZ |
| Jan 9, 1980 | K792448 | KODAK X-OMAT G FILM Eastman Kodak Company | IWZ |
| Jan 9, 1980 | K792435 | KODAK X-OMAT M20 PROCESSOR, MODEL 1 Eastman Kodak Company | IWZ |
| Jan 9, 1980 | K792434 | KODAK X-OMAT M20 PROCESSOR, MODEL 2 Eastman Kodak Company | IWZ |
| Jan 9, 1980 | K792317 | SR 301 MEDICAL X-RAY FILM E.I. Dupont DE Nemours & Co., Inc. | IWZ |
| Jan 9, 1980 | K792293 | KODAK ORTHO G FILM Eastman Kodak Company | IWZ |
| Jan 9, 1980 | K792178 | KODAK CFN FILM SO-224 Eastman Kodak Company | IWZ |
| Sep 4, 1979 | K791360 | KODAK ORTHO M FILM Eastman Kodak Company | IWZ |
| Apr 23, 1979 | K790629 | KODAK GRAY TONE IMAGING FILM Eastman Kodak Company | IWZ |
| Sep 14, 1977 | K771681 | ORTHO H FILM Eastman Kodak Company | IWZ |
| Jul 14, 1977 | K771223 | GRAY TONE IMAGING FILM Eastman Kodak Company | IWZ |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.