Panels › Obstetrics/Gynecology › Product code MQH · Class 2
Microtools, Assisted Reproduction (Pipettes)
Regulation 884.6130
1510(k)s in 12 months (27 all time)
0recalls in 12 months (4 all time)
4recalls that name a 510(k)
Top companies in MQH
| Company | 510(k)s | Recalls |
|---|---|---|
| Cook Vascular Inc. | 0 | 3 |
| Research Instruments , Ltd. | 3 | 0 |
| Cook Incorporated | 2 | 0 |
| Cook Urological, Inc. | 2 | 0 |
| Humagen Fertility Diagnostics, Inc. | 2 | 0 |
| Mid-Atlantic Diagnostics, Inc. | 2 | 0 |
| Sunlight Medical, Inc. | 2 | 0 |
| Swemed Lab International AB | 2 | 0 |
| Allwin Medical Devices, Inc. | 1 | 0 |
| Brinkmann Instruments, Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 27, 2019 | CooperSurgical, Inc. ICSI MICROPIPETTE
CooperSurgical part number: MICC001-30-B1.0 Terminated |
MQH | K990847 |
| Sep 18, 2008 | Cook Vascular Inc. Flexipet Manipulation pipette 300 micron. The device is used for the intracytoplasmic single sperm injection of oocytes. Terminated |
MQH | K983596 |
| Sep 18, 2008 | Cook Vascular Inc. Flexipet Denuding pipette 130 micron. The product is boxed with 5 vials of 10. The device is used for the intracytoplasmic single sperm injection of oocytes. Terminated |
MQH | K983596 |
| Sep 16, 2008 | Cook Vascular Inc. Flexipet Manipulation Pipette 300 micron. The product is boxed with 1 vial of 10 pipettes. This product is used for the intracytoplasmic single sperm injection of oocytes. Terminated |
MQH | K983596 |
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