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 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 9, 2026 | K262090 | Fertilis microICSI Device Fertilis Pty, Ltd., AU | MQK |
| Feb 20, 2025 | K241626 | SperSort Sperm Sorting Chip (IPG02) Ipreg Incorporation, TW | MQK |
| Feb 3, 2025 | K241454 | Minvitro® Vitrification Straw (MVT-VSN series, including MVT-VSNR, MVT-VSNY, MVT-VSNB, MVT-VSNG, MVT-VSNP) Guangzhou Hehong Biotech Co., Ltd., CN | MQK |
| Jan 31, 2025 | K241348 | SwimCount® Harvester (1 mL); SwimCount® Harvester (3 mL) Motilitycount Aps, DK | MQK |
| Sep 26, 2024 | K241341 | cryo-GO Vitrification Device Fujifilm Irvine Scientific | MQK |
| Jun 14, 2024 | K240002 | G-Vitri Vitrification Straw Gimbo Medical Technology Shenzhen Co., Ltd., CN | MQK |
| Mar 14, 2024 | K232980 | SpermAlign Sperm Separation Device Cytoswim, Ltd., GB | MQK |
| Mar 8, 2024 | K233177 | Nest VT Vitrification Device Cook Incorporated | MQK |
| Oct 31, 2022 | K221810 | LensHooke CA1 Sperm Separation Device, LensHooke CA0 Sperm Separation Device Bonraybio Co., Ltd., TW | MQK |
| Mar 11, 2022 | K213869 | EmbryoSlide+ ic8 dish Vitrolife A/S, DK | MQK |
| Jun 4, 2021 | K203626 | SureStrip Vitrification Straw, SureLock Vitrification Straw Allwin Medical Devices, Inc. | MQK |
| Dec 16, 2020 | K201213 | Pasteur Pipette 3mL, Pasteur Pipette 1mL Hertart Aps, SE | MQK |
| Jun 25, 2020 | K200815 | VitriGuard Origio A/S, DK | MQK |
| Jan 4, 2019 | K181461 | Rapid-i Kit Vitrolife Sweden AB, SE | MQK |
| Nov 9, 2018 | K181469 | Cryotop®US-flash and Cryotop®US-scoop Kitazato Corporation, JP | MQK |
| May 4, 2018 | K180740 | VitriGuard Origio A/S, DK | MQK |
| Mar 8, 2018 | K173075 | ZyMot ICSI Sperm Separation Device, ZyMot Multi Sperm Separation Device (850µl, 3ml) Dxnow, Inc. | MQK |
| Feb 9, 2018 | K172751 | iVitri Straw Reprobitech Corp. | MQK |
| Jun 30, 2017 | K162640 | iVitri EZ Reprobitech Corp. | MQK |
| Feb 16, 2017 | K162833 | VitriGuard Origio A/S, DK | MQK |
| Dec 14, 2016 | K162051 | Cryotec Reprolife, Inc., JP | MQK |
| Mar 14, 2016 | K153027 | Cryotop US Kitazato Biopharma Co., Ltd., JP | MQK |
| Dec 4, 2015 | K150961 | EmbryoSlide Culture Dish Vitrolife A/S, DK | MQK |
| Jul 20, 2015 | K150756 | Micro well group culture dish, 9-well; Micro well group culture dish, 16-well Hertart, SE | MQK |
| Dec 18, 2014 | K140207 | RAPID-I KIT Vitrolife Sweden AB | MQK |
| Jul 22, 2014 | K141663 | EEVA DISH (WITH 12 MICROWELLS) Auxogyn, Inc. | MQK |
| Jun 18, 2014 | K133295 | QUALIS Menicon Co., Ltd. New Business Division | MQK |
| Apr 3, 2014 | K140072 | CRYOTOP(R) SC Kitazato Biopharma Co., Ltd. | MQK |
| Feb 20, 2014 | K131145 | PROINSERT Nidacon International AB | MQK |
| Jan 9, 2014 | K122982 | CRYOLOCK Biotech, Inc. | MQK |
| Jul 3, 2013 | K123641 | CULTURE DISH 40 MM, CULTURE DISH 60 MM, MICRO DROPLET CULTURE DISH, 5 WELL CULTURE DISH, CENTRE WELL DISH, ICSI DISH Hertart, DK | MQK |
| Dec 19, 2012 | K112644 | SEAFORIA SPERM SEPARATION ASSISTANCE SYSTEM Lotus Bio, Ltd. | MQK |
| Dec 12, 2012 | K112695 | CRYOTOP Kitazato Biopharma Co;Ltd | MQK |
| Jul 13, 2012 | K112413 | RI MSC (MIGRATION SEDIMENTATION CHAMBER) Research Instruments , Ltd., GB | MQK |
| Aug 11, 2011 | K103028 | EEVATM PETRI DISH Auxogyn, Inc. | MQK |
| Dec 6, 2010 | K100596 | CRYOPETTE Mid-Atlantic Diagnostics, Inc. | MQK |
| Oct 6, 2010 | K092398 | HSV STRAW Cryo Bio System | MQK |
| Dec 23, 2009 | K090832 | RAPID-I Vitrolife Sweden AB, SE | MQK |
| Sep 18, 2009 | K090429 | NUNC IVF CENTERWELL AND ICSI DISHES Thermo Fisher Scientific (Nalge Nunc Intl) | MQK |
| Aug 20, 2008 | K081896 | BIOGENICS BIOQUAD 4-WELL IVF CULTURE DISH Biogenics, Inc. | MQK |
| Aug 13, 2008 | K080395 | SUNIVF DISHES <Genx> Intl., Inc. | MQK |
| May 18, 2007 | K070047 | NUNC IVF DISHES AND NUNC IVF 4-WELL DISH Nunc A/S, DK | MQK |
| Apr 13, 2006 | K052457 | PICSI SPERM SELECTION DEVICE Biocoat, Inc. | MQK |
| Aug 12, 2004 | K040717 | NUNC IVF MULTIDISH 4 WELLS NUNCLON Nunc A/S, DK | MQK |
| May 12, 2000 | K000915 | PASTEUR PIPET - STERILE 9, PASTEUR PIPET - STERILE 5 3/4, MODELS 16-PP-9, 16-PP-5.75 Humagen Fertility Diagnostics, Inc. | MQK |
| Feb 18, 2000 | K994361 | ESP FOUR WELL TISSUE CULTURE PLATE, ESP SIX WELL TISSUE CULTURE PLATE, ESP MICRO SIX WELL TISSUE CULTURE PLATE, ESP WELL Genesis Industries, Inc. | MQK |
| Feb 14, 2000 | K993881 | GENX CULTURE DISH <Genx> Intl., Inc. | MQK |
| Jul 14, 1999 | K990941 | NEWLIFE DISH (ETCHED OR NON-ETCHED, WITH OR WITHOUT LID), MODELS 14-52, 1452E, 1452EL, 1452L Humagen Fertility Diagnostics, Inc. | MQK |
| May 5, 1999 | K991253 | FALCON IVF ROUND DISH Becton Dickinson Labware | MQK |
| May 5, 1999 | K991251 | FALCON IVF ONE WELL DISH Becton Dickinson Labware | MQK |
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