Container, Specimen, Sterile
Regulation 864.3250
0510(k)s in 12 months (23 all time)
3recalls in 12 months (21 all time)
2recalls that name a 510(k)
Top companies in FMH
| Company | 510(k)s | Recalls |
|---|---|---|
| MEDLINE INDUSTRIES, LP - Northfield | 0 | 4 |
| Sage Products, Inc. | 4 | 0 |
| Customed, Inc | 0 | 3 |
| Medline Industries, LP | 0 | 3 |
| Thermo Fisher Scientific (Monterrey) | 0 | 3 |
| C.R. Bard, Inc. | 2 | 0 |
| Klinika Mdical Gmb | 0 | 2 |
| Meridian Bioscience Inc | 0 | 2 |
| Sherwood Medical Co. | 2 | 0 |
| Abco Dealers, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 17, 1990 | K900983 | TRI-TECH URINE SPECIMEN KIT Tri-Tech, Inc. | FMH |
| Jan 19, 1983 | K823763 | VARIOUS-SPECIMEN COLLECTORS Cordis Corp. | FMH |
| Feb 5, 1982 | K820180 | CALCULI FILTER CUP Omnimedical | FMH |
| Nov 6, 1981 | K812933 | LANCER SPECIMEN CONTAINER Sherwood Medical Co. | FMH |
| Oct 10, 1980 | K802340 | SPECIMEN SET American Pharmaseal Div. Ahsc | FMH |
| Sep 9, 1980 | K802002 | URINE SPECIMEN CONTAINER #'S 1013-1016 Pollak (Intl.), Ltd. | FMH |
| May 30, 1980 | K800947 | MIDSTREAM COLLECTION KIT Sage Products, Inc. | FMH |
| Feb 26, 1980 | K800309 | SPECIMEN COLLECTION PAN Sage Products, Inc. | FMH |
| Feb 26, 1980 | K800233 | ABCO MIDSTREAM URINE COLLECTION SET Abco Dealers, Inc. | FMH |
| Jan 28, 1980 | K792710 | PARA-PAK CLEAN VIAL Meridian Diagnostics, Inc. | FMH |
| Dec 10, 1979 | K792156 | LANCER SPECIMEN CONTAINER Sherwood Medical Co. | FMH |
| Nov 16, 1979 | K792211 | SPECIMAN CUP & EMESIS BASIN General Clinical Plastics Corp. | FMH |
| Jun 27, 1979 | K790915 | JUHN TYM-TAP Xomed, Inc. | FMH |
| Apr 10, 1979 | K790291 | OPERATING ROOM SPECIMEN CONTAINER Sage Products, Inc. | FMH |
| Oct 17, 1978 | K781557 | 24-HOUR URINE COLLECTION COOLING WRAP Sage Products, Inc. | FMH |
| Feb 21, 1978 | K780167 | CATH KIT, URINE SPECIMEN C.R. Bard, Inc. | FMH |
| Feb 21, 1978 | K780057 | URINE SAMPLE COLLECTION KIT C.R. Bard, Inc. | FMH |
| Jan 26, 1978 | K780049 | SPECIMEN COLLECTION DEVICE Urol, Inc. | FMH |
| Apr 5, 1977 | K770387 | UNICATCH W.G. Whitney Corp. | FMH |
| Mar 30, 1977 | K770231 | MID-STREAM COLLECTION SET Chesire Laboratories | FMH |
| Mar 14, 1977 | K770112 | SPECIMEN COLLECTOR Portex, Inc. | FMH |
| Feb 28, 1977 | K761191 | 4 1/2 OZ. GRADUATED SPECIMEN CONTAINER Superior Plastic Products Corp. | FMH |
| Nov 12, 1976 | K760496 | CUP, DISPOSABLE SPECIMEN Landmark Plastics | FMH |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.