Panels › Obstetrics/Gynecology › Product code HGY · Class 1
Pump, Breast, Non-Powered
Regulation 884.5150
0510(k)s in 12 months (27 all time)
0recalls in 12 months (2 all time)
2recalls that name a 510(k)
Top companies in HGY
| Company | 510(k)s | Recalls |
|---|---|---|
| Medela, Inc. | 3 | 0 |
| Ameda, Inc. | 0 | 2 |
| American Hospital Supply Corp. | 2 | 0 |
| Gerber Products Co. | 2 | 0 |
| Hollister, Inc. | 2 | 0 |
| Avent America, Inc. | 1 | 0 |
| Burditt & Calkins-Siemens-Elema | 1 | 0 |
| Crystal Medical Products, Inc. | 1 | 0 |
| D.J. Colgate Medical, Ltd. | 1 | 0 |
| Eklund & Co. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 5, 2010 | K101538 | HANDHELD MANUAL BREAST PUMP (AVENT MANUAL BREAST PUMP) Philips Electronics UK Limited, GB | HGY |
| Apr 5, 2004 | K032845 | EASY COMFORT DELUXE MANUAL BREAST PUMP, MODEL 1187 The First Years, Inc. | HGY |
| Dec 20, 2001 | K013226 | EVENFLO COMFORT EASE MANUAL BREAST PUMP KIT Evenflo Company, Inc. | HGY |
| Aug 15, 2001 | K011519 | AMEDA HYGIENIKIT Hollister, Inc. | HGY |
| May 19, 1997 | K971231 | WHITE RIVER MINI MANUAL BREAST PUMP White River Concepts | HGY |
| Feb 10, 1997 | K962828 | EVERT-IT Genesis Industries, Inc. | HGY |
| Sep 12, 1995 | K952034 | MEDELA'S FOOT PUMP Medela, Inc. | HGY |
| Jul 28, 1995 | K952035 | NIPLETTE Avent America, Inc. | HGY |
| May 4, 1994 | K925738 | WHITE RIVER MANUAL BREAST PUMP White River (Tm) | HGY |
| Dec 10, 1993 | K912355 | MOTHERS TOUCH ONE HAND BREAST PUMP Hollister, Inc. | HGY |
| Sep 26, 1990 | K902552 | GERBER PRECIOUS CARE ELECTRIC BREAST PUMP Gerber Products Co. | HGY |
| Feb 25, 1985 | K850242 | CRYSTAL MANUAL BREAST PUMP Crystal Medical Products, Inc. | HGY |
| Feb 25, 1985 | K844297 | SUPPLEMENTAL FEEDING SYSTEM Medela, Inc. | HGY |
| Jan 25, 1985 | K843544 | THE BIBICURE SYS BREAST TONER Les Entreprises Bibi, Inc., CA | HGY |
| Jul 23, 1984 | K840874 | RODY BREAST PUMP Kean-Rody Manufacturer | HGY |
| Mar 5, 1984 | K840325 | INFA COMPLETE BREAST PUMP & MILK STORAG Monterey Laboratories, Inc. | HGY |
| Jan 17, 1984 | K834399 | NEW MOTHER'S WAY-BREAST PUMP Huntleigh Technology, Inc. | HGY |
| Nov 28, 1983 | K833835 | GENTLE FLOW BREAST PUMP Eklund & Co. | HGY |
| Sep 29, 1983 | K831929 | BASIC BREAST PUMP Terayco Intl., Ltd. | HGY |
| Sep 12, 1983 | K832597 | GERBER PRECISION CARE BREAST PUMP Gerber Products Co. | HGY |
| Jan 24, 1983 | K823840 | MEDELA NAMUAL BREAST PUMP Medela, Inc. | HGY |
| Jan 18, 1983 | K823461 | AXIPUMP MANUAL BREAST PUMP D.J. Colgate Medical, Ltd. | HGY |
| Dec 28, 1982 | K823591 | AMEDA HAND BREAST PUMP Burditt & Calkins-Siemens-Elema | HGY |
| Sep 21, 1982 | K822403 | LACT-ASSIST BREAST PUMP Lact-Assist, Inc. | HGY |
| Dec 3, 1981 | K813247 | KANESON/COMFORT PLUS MANUAL BREAST PUMP Marshall Electronics, Inc. | HGY |
| Feb 12, 1981 | K810100 | BREAST PUMP American Hospital Supply Corp. | HGY |
| Nov 11, 1976 | K760911 | BREAST CARE KIT American Hospital Supply Corp. | HGY |
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