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 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 24, 2026 | Clinical Innovations, LLC Brand Name: Kiwi Omni Vacuum Delivery System
Product Name: Kiwi Omni Vacuum Delivery System
Model/Catalog Number: VAC-6000MT
Product Description: The Clinical Innovations Kiwi is a disposable vacuum Open, Classified |
HDB | K981260 |
| Aug 6, 2019 | Clinical Innovations, LLC Kiwi Complete Vacuum Delivery System, Model No. VAC-6000MTE - Product Usage: The Kiwi is a disposable vacuum-assisted fetal delivery system. Terminated |
HDB | K981260 |
| Sep 17, 2008 | Cooper Surgical, Inc. Mystic II M-Style Mushroom Cup Vacuum Assisted Delivery System (Ref: 10057). Product is intended to assist a clinician in the delivery of an infant during childbirth. Indicated for use during vagina Terminated |
HDB | K011532 |
| Sep 17, 2008 | Cooper Surgical, Inc. M-Style Cup with Universal Vacuum Release (UVR) used with wall suction, Vacuum Assisted Delivery System (Ref: 10015LP). Product is intended to assist a clinician in the delivery of an infant during c Terminated |
HDB | K011532 |
| Sep 17, 2008 | Cooper Surgical, Inc. M-Style Mushroom Cup Vacuum Assisted Delivery System used with hand pump (Ref: 10007LP). Product is intended to assist a clinician in the delivery of an infant during childbirth. Indicated for use Terminated |
HDB | K011532 |
| Oct 5, 2004 | CooperSurgical, Inc. Mystic M-Style Mushroom Cup Mityvac Vacuum Assisted Delivery System
Product No: 10047 Terminated |
HDB | K011532 |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.