Panels › General Hospital › Product code HFS · Class 1
Shield, Nipple
Regulation 880.5630
0510(k)s in 12 months (12 all time)
0recalls in 12 months (1 all time)
0recalls that name a 510(k)
Top companies in HFS
| Company | 510(k)s | Recalls |
|---|---|---|
| Medela, Inc. | 2 | 1 |
| Marshall Baby Products | 2 | 0 |
| Avent America, Inc. | 1 | 0 |
| Mali, Inc. | 1 | 0 |
| Neonatal Corp. | 1 | 0 |
| O'Donnell, Byrne & Williams | 1 | 0 |
| Prolac, Inc. | 1 | 0 |
| Reliance Products Corp. | 1 | 0 |
| Sherwood Medical Co. | 1 | 0 |
| Unicare Medical Products, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 5, 1994 | K944177 | BREAST SHELL O'Donnell, Byrne & Williams | HFS |
| Oct 5, 1994 | K944117 | AVENT NIPPLE SHIELD Avent America, Inc. | HFS |
| Jan 21, 1994 | K935341 | COMFORT PLUS BREAST SHELLS Marshall Baby Products | HFS |
| Jan 21, 1994 | K935340 | COMFORT PLUS NIPPLE SHIELDS Marshall Baby Products | HFS |
| Aug 16, 1993 | K930238 | BREAST LEAKAGE INHIBITOR SYSTEM: BREAST SHIELDS Prolac, Inc. | HFS |
| Jan 22, 1993 | K923577 | BREAST SHELLS Medela, Inc. | HFS |
| Nov 4, 1986 | K864176 | GENTLE FEEL Mali, Inc. | HFS |
| Jul 15, 1986 | K861608 | UNICARE BREAST SHELLS Unicare Medical Products, Inc., CA | HFS |
| Aug 22, 1985 | K853176 | CANNON BABYSAFE NIPPLE SHIELDS Medela, Inc. | HFS |
| Jun 28, 1984 | K840877 | ARGYLE ENTERNAL FEEDING BAG W/ADMIN Sherwood Medical Co. | HFS |
| Nov 21, 1983 | K833450 | NUK BREAST SHIELD Reliance Products Corp. | HFS |
| Aug 3, 1981 | K811364 | AXICARE BREAST SHELL Neonatal Corp. | HFS |
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