Panels › Obstetrics/Gynecology › Product code HGX · Class 2
Pump, Breast, Powered
Regulation 884.5160
38510(k)s in 12 months (254 all time)
0recalls in 12 months (8 all time)
8recalls that name a 510(k)
Top companies in HGX
| Company | 510(k)s | Recalls |
|---|---|---|
| Medela AG | 19 | 6 |
| Shenzhen TPH Technology Co., Ltd. | 24 | 0 |
| Uzinmedicare Co. | 12 | 0 |
| Shenzhen Root Innovation Technology Co., Ltd. | 11 | 0 |
| Evenflo Co., Inc. | 9 | 0 |
| Guangdong Horigen Mother & Baby Products Co., Ltd. | 6 | 0 |
| Ardo Medical AG | 5 | 0 |
| Crystal Medical Products, Inc. | 4 | 0 |
| Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd. | 4 | 0 |
| Guangdong Youmeng Electrical Technology Co., Ltd. | 4 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 22, 2005 | K052047 | ISIS IQ UNO HANDHELD ELECTRONIC BREAST PUMP, MODEL 101 Avent America, Inc. | HGX |
| Sep 7, 2005 | K051112 | WHITTLESTONE EXPRESSER Whittlestone, Inc. | HGX |
| Aug 29, 2005 | K051413 | ISIS IQ DUO TWIN ELECTRONIC BREAST PUMP, MODEL 100 Avent America, Inc. | HGX |
| Dec 15, 2004 | K043098 | GERBER DOUBLE ELECTRIC BREAST PUMP Gerber Products Co. | HGX |
| Oct 30, 2003 | K033131 | NATURAL COMFORT DOUBLE ELECTRIC/BATTERY BREAST PUMP, MODEL 1181/1068 The First Years, Inc. | HGX |
| Sep 15, 2003 | K032566 | NATURAL COMFORT BATTERY/ELECTRIC BREAST PUMP The First Years, Inc. | HGX |
| Jun 6, 2003 | K031614 | MEDELA PUMP IN STYLE ADVANCED BREAST PUMP Medela, Inc. | HGX |
| Jan 10, 2003 | K021739 | LIMERICK POWERED ELECTRIC BREAST PUMP MODEL 1002 Limerick, Inc. | HGX |
| Dec 2, 2002 | K022933 | EVENFLO COMFORT SELECT AUTO-CYCLE BREAST PUMP KIT Evenflo Company, Inc. | HGX |
| Nov 1, 2002 | K022594 | PLAYTEX BREAST PUMP Playtex Products, Inc. | HGX |
| Sep 30, 2002 | K022140 | WHISPER WEAR BREAST PUMP Whisper Wear | HGX |
| May 3, 2002 | K020375 | THE NURTURE III BREAST PUMP Bailey Medical Engineering | HGX |
| Mar 7, 2002 | K020518 | MEDELA SYMPHONY BREAST PUMP, MODEL 024 Medela, Inc., CH | HGX |
| Jan 7, 2002 | K012275 | PJ.S COMFORT PORTABLE ELECTRIC BREAST PUMP Limerick, Inc. | HGX |
| Mar 21, 2001 | K002696 | WHITTLESTONE BREASTPUMP Whittlestone, Inc. | HGX |
| May 24, 1999 | K981549 | LACTATION TECHNIQUES MODEL B Lactation Techniques, Inc. | HGX |
| Apr 26, 1999 | K983776 | EVENFLO COMFORT CONTROL BREAST PUMP, EVENFLO COMFORT CONTROL DUAL BREAST PUMP Evenflo Co., Inc. | HGX |
| Dec 11, 1997 | K973501 | EXPRESSE AND PREMIER POWERED BREAST PUMPS Ameda Medizintechnik AG | HGX |
| Nov 4, 1997 | K970488 | HYDROCHECK MICRO FILTER White River Concepts | HGX |
| Sep 18, 1997 | K971543 | LUXMATIC 12-15 ISC PORTABLE ELECTRIC BREAST PUMP Kaweco GmbH | HGX |
| Jun 10, 1997 | K964679 | WHITE RIVER AUTOMATIC BREAST PUMP White River Concepts | HGX |
| Jun 6, 1997 | K964396 | DOUBLE UP BREAST PUMP The Natural Choice Co., Inc. | HGX |
| Feb 14, 1997 | K960727 | EVENFLO NATURAL MOTHER ELECTRIC BREAST PUMP KIT Evenflo Co., Inc. | HGX |
| Jan 13, 1997 | K964403 | SIMPLICITY TM ELECTRIC/BATTERY BREAST PUMP KIT (1068) The First Years, Inc. | HGX |
| Jul 22, 1996 | K960726 | EVENFLO SOFT-TOUCH ULTRA BATTERY OPERATED BREAST PUMP Evenflo Co., Inc. | HGX |
| Apr 18, 1996 | K952712 | WHITE RIVER BATTERY-POWERED BREAST PUMP Natural Technologies, Inc. | HGX |
| Oct 16, 1995 | K950750 | MEDELAS BREAST PUMP Medela, Inc. | HGX |
| Sep 22, 1995 | K950531 | EGNELL ELITE Hollister, Inc. | HGX |
| May 25, 1995 | K942534 | GERBER NATURAL COMFORT BATTERY BREAST PUMP Gerber Products Co. | HGX |
| May 11, 1995 | K924312 | NURTURE III Bailey Medical Engineering | HGX |
| Jan 30, 1995 | K941112 | SINGLE HANDED BREAST PUMP Macneil Baby Care , Ltd. | HGX |
| Nov 30, 1994 | K936309 | DELUXE MAGMAG BREAST PUMP Pigeon Corp., JP | HGX |
| Nov 22, 1994 | K935249 | ADVANCED MAGMAG AC/BATTERY BREAST PUMP Pigeon Corp., JP | HGX |
| Nov 9, 1993 | K921261 | ELECTRIC POWERED BREAST PUMP Schuco, Inc. | HGX |
| Aug 6, 1990 | K901344 | MEDELA BATTERY OPERATED BREAST PUMP Medela, Inc. | HGX |
| Mar 5, 1990 | K895114 | FRANK MILK PUMP Buttner-Frank GmbH, DE | HGX |
| Feb 16, 1990 | K893545 | IVEX MODEL NO. BP 3000 BREASTPUMP Ivex Medical, Inc. | HGX |
| Aug 7, 1989 | K891996 | GERBER PRECIOUS CARE ELECTRIC BREAST PUMP Gerber Products Co. | HGX |
| May 16, 1989 | K890588 | GENTLE EXPRESSIONS ELECTRIC BREAST PUMP Healthteam | HGX |
| Apr 6, 1988 | K875300 | MEDELA BREAST-PUMP LACTINA Medela, Inc. | HGX |
| Dec 8, 1987 | K874071 | MOTHER'S MILK BAG Yanase Waitch K.K., JP | HGX |
| Aug 8, 1986 | K861513 | LA DIFFUSION TECHNIQUE, KTY CM-10 BREAST PUMP Crystal Medical Products, Inc. | HGX |
| Nov 19, 1985 | K853326 | WATER DRIVEN BREAST PUMP BY BABY NURSE Baby Nurse | HGX |
| Nov 19, 1985 | K853107 | AXICARE CM-14 AUTOMATIC BREAST PUMP Crystal Medical Products, Inc. | HGX |
| Nov 14, 1985 | K852460 | GENTLE EXPRESSIONS AUTOMATIC BREAST PUMP & FEED SY Healthteam | HGX |
| Jul 11, 1985 | K850705 | THE WHITE RIVER PORTA-ELEC-BREAST PUMP Natural Technologies, Inc. | HGX |
| Jun 7, 1985 | K850753 | NATURAL MOTHER BREAST PUMP Crystal Medical Products, Inc. | HGX |
| Feb 15, 1985 | K844013 | CARE ELECTRIC BREAST PUMP Hankscraft Div. of Gerber Products Co. | HGX |
| Feb 4, 1985 | K844307 | EGNELL-LACT B BATTERY-OPERATED BREAST PUMP Egnell, Inc. | HGX |
| Sep 25, 1984 | K842766 | CRYSTAL MEDICAL MILK COLLECTION KIT Crystal Medical Products, Inc. | HGX |
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