Panels › Obstetrics/Gynecology › Product code MQE · Class 2
Needle, Assisted Reproduction
Regulation 884.6100
1510(k)s in 12 months (33 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in MQE
| Company | 510(k)s | Recalls |
|---|---|---|
| CooperSurgical, Inc. | 3 | 0 |
| <Genx> Intl., Inc. | 3 | 0 |
| Vitrolife Sweden AB | 3 | 0 |
| Rocket Medical Plc | 2 | 0 |
| Sims Portex , Ltd. | 2 | 0 |
| William A. Cook Australia Pty. , Ltd. | 2 | 0 |
| Allwin Medical Devices, Inc. | 1 | 0 |
| Casmed UK | 1 | 0 |
| Cook Ob/Gyn | 1 | 0 |
| Cook Urological, Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 22, 2008 | Irvine Scientific Sales Co Inc Wallace Oocyte Recovery Needles,Oocyte Recovery sets, 750 mm tube with flushing connector, Product Number: KLN-750, and KLN-750.
Retrieval of Oocytes. Terminated |
MQE | K000628 K012068 |
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