Panels › Obstetrics/Gynecology › Product code MQK · Class 2
Labware, Assisted Reproduction
Regulation 884.6160
1510(k)s in 12 months (51 all time)
0recalls in 12 months (4 all time)
4recalls that name a 510(k)
Top companies in MQK
| Company | 510(k)s | Recalls |
|---|---|---|
| Becton Dickinson Labware | 3 | 0 |
| Humagen Fertility Diagnostics, Inc. | 2 | 1 |
| Kitazato Biopharma Co., Ltd. | 3 | 0 |
| Origio A/S | 3 | 0 |
| Vitrolife Sweden AB | 3 | 0 |
| Auxogyn, Inc. | 2 | 0 |
| <Genx> Intl., Inc. | 2 | 0 |
| Hertart | 2 | 0 |
| Nunc A/S | 2 | 0 |
| Reprobitech Corp. | 2 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 1, 2022 | CooperSurgical, Inc. VITRIGUARD, CARRIER, CLEAR; Model. No. 43782001
The VitriGuard device is a cryopreservation storage device composed of a stick and cap. Open, Classified |
MQK | K162833 |
| Jun 30, 2014 | ORIGIO, Inc Name: Pasteur Pipets, used by the embryologist in the IVF Laboratory.
Model numbers:
PP-5.75-90
PP-9-90
PP-5.75-90PL
PP-9-90PL Terminated |
MQK | K000915 |
| Feb 23, 2012 | ORIGIO HUMAGEN PIPETS INC. ORIGIO MIDATLANTIC DEVICES CRYOPETTE (r) Rx only Single use only CRY-PETTE-CL LOT 123456 2013-10-10 Exp. date *** MADE IN THE USA STERILE R ***Origio, Inc. 3400 Hunter's Way, Charlottesville, VA 2291 Terminated |
MQK | K100596 |
| Sep 18, 2007 | Humagen Fertility Diagnostics, Inc. IVF Pasteur Pipettes, glass, cotton plugged, length 9", in boxes of 90 consisting of 30 nylon tube packages of 3 pipettes each. Item # PP-9-90PL. Boxes are labeled in part ***Humagen Fertility Diagno Terminated |
MQK | K000915 |
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