Panels › Obstetrics/Gynecology › Product code HDB · Class 2
Extractor, Vacuum, Fetal
Regulation 884.4340
0510(k)s in 12 months (30 all time)
1recalls in 12 months (6 all time)
6recalls that name a 510(k)
Top companies in HDB
| Company | 510(k)s | Recalls |
|---|---|---|
| Neward Enterprises, Inc. | 5 | 0 |
| Clinical Innovations, Inc. | 2 | 2 |
| Challenge Mfg., Inc. | 3 | 0 |
| Cooper Surgical, Inc. | 0 | 3 |
| Medela AG | 3 | 0 |
| Swift Delivery Products | 3 | 0 |
| Columbia Medical & Surgical, Inc. | 2 | 0 |
| Go Medical Industries Pty. , Ltd. | 2 | 0 |
| Hollister, Inc. | 2 | 0 |
| Prism Enterprises, Inc. | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 8, 2025 | K250298 | Kiwi® Complete Vacuum Delivery System, OmniCup® (VAC-DUAL M); Kiwi® Complete Vacuum Delivery System, OmniCup® with Tract Clinical Innovations, LLC | HDB |
| Apr 21, 2005 | K041579 | MEDELA SINGLE USE SILC CUP, MODEL 077.0791 Medela AG, CH | HDB |
| Apr 14, 2005 | K043614 | VACULINK, MODEL VCL 3000 Medevco, Inc. | HDB |
| Feb 12, 2003 | K021193 | FORTUNE SILICONE VACUUM SUCTION, MODEL #1300 Fortune Medical Instrument Corp., TW | HDB |
| Apr 12, 2002 | K020447 | MITYVAC MERLIN, MODEL 10027 Prism Enterprises, Inc. | HDB |
| Jan 17, 2002 | K013460 | SWIFT LOW PROFILE CUP (PRO CUP) Swift Delivery Products | HDB |
| Jul 30, 2001 | K011532 | MITYVAC Prism Enterprises, Inc. | HDB |
| Sep 22, 1998 | K981260 | KIWI SOFT CUP WITH PALM PUMP MODEL NUMBER VFE-6000S, KIWI MUSHROOM CUP WITH PALM PUMP MODEL VFE-6000M Clinical Innovations, Inc. | HDB |
| Aug 21, 1998 | K980976 | AMEDA DISPOSABLE VACUUM ASSIST CUP WITH FLUID RETENTION TRAP Hollister, Inc. | HDB |
| Jul 9, 1998 | K980212 | MITYVAC Prism Technologies, Inc. | HDB |
| Dec 12, 1997 | K973942 | SWIFT DELIVERY PRODUCT #300 Swift Delivery Products | HDB |
| Mar 28, 1997 | K970170 | SWIFT DELIVERY PRODUCT #002-VAC EX CUP W/VAC REL VALVE Richard G. Lindsay | HDB |
| Oct 28, 1996 | K963287 | VACUUM CUP (004SD) Swift Delivery Products | HDB |
| Aug 29, 1996 | K960549 | MITYVAC DIRECTIONAL VACUUM EXTRACTOR, DISPOSABLE Neward Enterprises, Inc. | HDB |
| May 5, 1995 | K942725 | CMI VELVET TOUCH VACUUM EXTRACTOR Columbia Medical & Surgical, Inc. | HDB |
| May 3, 1995 | K943938 | MITYVAC SUPER M STYLE VACUM EXTRACTOR, DISPOSABLE Neward Enterprises, Inc. | HDB |
| May 4, 1994 | K934011 | MITYVAC(R) OBSTETRIC VAC DELIV KIT W/UNIV VAC RELEASE Neward Enterprises, Inc. | HDB |
| Jun 22, 1992 | K913324 | MITYVAC(R) SAFTISOFT OBSTETRICAL VACUUM DELIV KIT Neward Enterprises, Inc. | HDB |
| Mar 18, 1992 | K915763 | MODIFIED DISPOSABLE FETAL VACUUM Columbia Medical & Surgical, Inc. | HDB |
| Aug 14, 1991 | K911326 | OBSTETRICAL VACUUM CUP Gesco Intl., Inc. | HDB |
| Apr 2, 1990 | K895700 | AMEDA/EGNELL DOLPHIN DISPO-SOFT VACUUM EXTRACTOR Hollister, Inc. | HDB |
| Nov 27, 1989 | K895446 | CMI VACUUM PUMP W/#101A VACUUM PUMP (AUTO-CLAVE.) Challenge Mfg., Inc. | HDB |
| May 11, 1989 | K891465 | OBSTETRIC CUP (MODIFICATION) Go Medical Industries Pty. , Ltd., AU | HDB |
| Mar 31, 1989 | K890307 | MITYVAC M STYLE VACUUM EXTRACTOR, DISPOSABLE Neward Enterprises, Inc. | HDB |
| Jun 13, 1988 | K881967 | CMI VACUUM PUMP #001C - VACUUM PUMP (NON-ELECTRI.) Challenge Mfg., Inc. | HDB |
| Jun 13, 1988 | K881306 | CMI VACUUM DELIVERY SYSTEM #003C AND #004C Challenge Mfg., Inc. | HDB |
| May 7, 1984 | K841492 | AB VACUUM EXTRACTOR SILC-CUP Medela, Inc. | HDB |
| Apr 25, 1984 | K840008 | O'NEIL OBSTETRIC CUP Go Medical Industries Pty. , Ltd. | HDB |
| Jan 24, 1983 | K830012 | MEDELA SUCTION PUMP Medela, Inc. | HDB |
| Sep 20, 1977 | K771558 | SILASTIC BRAND OBSTETRICAL VACUUM CUP Dow Corning Corp. Healthcare Industries Materials | HDB |
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