Panels › Obstetrics/Gynecology › Product code MQG · Class 2
Accessory, Assisted Reproduction
Regulation 884.6120
2510(k)s in 12 months (47 all time)
0recalls in 12 months (9 all time)
8recalls that name a 510(k)
Top companies in MQG
| Company | 510(k)s | Recalls |
|---|---|---|
| Zander Medical Supplies, Inc. | 5 | 0 |
| Cook Inc. | 0 | 4 |
| CooperSurgical, Inc. | 1 | 3 |
| Unisense Fertilitech A/S | 4 | 0 |
| Genea Biomedx Pty, Ltd. | 3 | 0 |
| <Genx> Intl., Inc. | 3 | 0 |
| At Medical Uab | 2 | 0 |
| Cook Medical Llc | 0 | 2 |
| Cook Ob/Gyn | 2 | 0 |
| Cook Urological, Inc. | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 19, 2026 | K261083 | Wallace® Aspiration Pump (WAPV1); Wallace® Pump Filter Connector (WFC); Wallace® Vacuum Connection Kit (WVCK) CooperSurgical, Inc. | MQG |
| Apr 28, 2026 | K260194 | Vacuum Pump (Model: AD-VPUM-500) Sheng Sheng Yi (Beijing) Technology Company Limited, CN | MQG |
| May 22, 2025 | K242684 | Harioculture TL-16 Time-lapse Incubator Hua Yue Medical Technology Co., Ltd., CN | MQG |
| May 7, 2024 | K232493 | Embryo Real-time Incubator (TLS301), Embryo Real-time Culture Dish (MC 2004) Wuhan Huchuang Union Technology Co., Ltd., CN | MQG |
| Jun 7, 2018 | K180188 | Geri Embryo Incubator with Geri Connect and Geri Assess Software, and Geri Dish Genea Biomedx Pty, Ltd., AU | MQG |
| May 11, 2018 | K173264 | EmbryoScope+ Vitrolife A/S, DK | MQG |
| Apr 20, 2018 | K180304 | Geri Embryo Incubator and Geri Dish Genea Biomedx Pty, Ltd., AU | MQG |
| Nov 15, 2017 | K171736 | Geri Embryo Incubator and Geri Dish Genea Biomedx Pty, Ltd., AU | MQG |
| Jun 13, 2017 | K160753 | COOK Vacuum Pump William A. Cook Australia Pty. , Ltd., AU | MQG |
| Jul 18, 2016 | K160504 | RI Witness Embryology Heated Plate Research Instruments Limited, GB | MQG |
| Apr 22, 2016 | K151357 | MIRI TL At Medical Uab, LT | MQG |
| Aug 8, 2014 | K133712 | EMBRYOVIEWER SOFTWARE Unisense Fertilitech A/S, DK | MQG |
| May 7, 2014 | K132870 | Origio Gas Line Filter Origio, Inc. | MQG |
| Apr 23, 2014 | K133742 | XQ-1 INCUBATOR At Medical Uab, LT | MQG |
| Nov 29, 2012 | K121566 | PLANER BT37 INCUBATOR Planer Plc | MQG |
| Dec 21, 2011 | K113075 | EMBRYO VIEWER SOFTWARE Unisense Fertilitech A/S, DK | MQG |
| Aug 11, 2011 | K111715 | EMBRYOSCOPE Unisense Fertilitech A/S, DK | MQG |
| Feb 8, 2011 | K101988 | HEAL FORCE CO2 INCUBATOR Shanghai Lishen Scientific Equipment Co., Ltd. | MQG |
| Jan 11, 2011 | K092183 | EMBRYOSCOPE AND EMBRYOSLIDE Unisense Fertilitech A/S, DK | MQG |
| Oct 6, 2006 | K050197 | MINITUBE TEMPERATURE CONTROL UNIT SC-2000 + 2045 Minitube of America, Inc. | MQG |
| Sep 8, 2005 | K041952 | ZIVF-AIRE Zander Medical Supplies, Inc. | MQG |
| Mar 19, 2004 | K032086 | KRYO ART CONTROLLED RATE FREEZER Planer Plc | MQG |
| Aug 29, 2003 | K032526 | BINDER CO2 INCUBATOR SERIE CB Binder GmbH, DE | MQG |
| Aug 27, 2003 | K030525 | CUSTOM PRODUCTS IVF WORKSTATION TYPE WKST-24*36, WKST-24*48, WKST-24*60, WKST-24*72 AND WKST-24*72D PLUS ACCESSORIES Mid-Atlantic Diagnostics, Inc. | MQG |
| Mar 10, 2003 | K023465 | KENDRO HERACELL 240 INCUBATOR Kendro Laboratory Products, L.P. | MQG |
| Aug 15, 2002 | K011327 | DB1 EMBRYO FREEZE Zander Medical Supplies, Inc. | MQG |
| Jun 19, 2002 | K020560 | WORKBENCH BY <GENX> Genx Intl., Inc. | MQG |
| May 15, 2002 | K021042 | THERMO FORMA, CRYOMED, CONTROLLED RATE FREEZERS; MODELS # 7456, 7457, 7458,7459,7475,7476 Thermo Forma, Inc. | MQG |
| Feb 8, 2002 | K014160 | PGD-PRE-IMPLANTATION GENETIC DIAGNOSTIC PIPETTES (BIOPSY PIPETTES) Cook Urological, Inc. | MQG |
| Dec 14, 2001 | K013703 | SANYO CO2 INCUBATORS, MODELS NOS. MCO-17AC, MCO-17AIC, MCO-20AIC,AND MC0-175M Sanyo North America Corp. | MQG |
| Dec 14, 2001 | K013401 | K-SYSTEMS CULTURE BAG SEALER AND CULTURE BAGS TYPE CBS-1 AND CB-01 K-Systems, Kivex Biotec , Ltd., DK | MQG |
| Dec 15, 2000 | K002971 | MTG - MINITUB HEATED STAGE SYSTEMS Zander Medical Supplies, Inc. | MQG |
| Nov 22, 2000 | K001600 | <GENX> CODA INCUBATOR CELLMATE <Genx> Intl., Inc. | MQG |
| Nov 21, 2000 | K002961 | MINITUB MULTI-PURPOSE CASSETTES Zander Medical Supplies, Inc. | MQG |
| Nov 20, 2000 | K003184 | RS BIOTECH GALAXY 'R' CO2 INCUBATOR Zander Medical Supplies, Inc. | MQG |
| Nov 17, 2000 | K002595 | CBS STRAW Cryo Bio System | MQG |
| Nov 9, 2000 | K002805 | KENDRO HERACELL CO2 INCUBATOR Kendro Laboratory Products, L.P. | MQG |
| Sep 15, 2000 | K001486 | GENX CODA AIR PURIFICATION SYSTEM <Genx> Intl., Inc. | MQG |
| Jul 12, 2000 | K001524 | FORMA SCIENTIFIC DIRECT HEAT INCUBATORS Thermoquest Corp. | MQG |
| Feb 29, 2000 | K000394 | CRAFT DUO-VAC SUCTION UNIT AND CRAFT SUCTION UNIT Rocket Medical Plc, GB | MQG |
| Oct 27, 1999 | K992070 | COOK ULTRA QUIET VACUUM PUMP & REGULATOR Cook Urological, Inc. | MQG |
| Aug 5, 1999 | K991216 | HOFFMAN IVF-1 (Arms) Hoffman Surgical Equipment, Ivf Division | MQG |
| Jul 19, 1999 | K991408 | FORMA SCIENTIFIC UNIVERSAL WATER-JACKETED INCUBATOR Thermoquest Corp. | MQG |
| Jul 8, 1999 | K991263 | THERMOPLATE Tokai Hit Co., Ltd., JP | MQG |
| Jun 29, 1999 | K991229 | K-SYSTEMS WORK STATIONS, TYPE L-13W, L-13E, L-13ES, L-13ET, L-13EM, L-23, L-23E, L-24, L-24E, L-25, L-25E, L-26, L-26E,L Henning Knudsen Engineering A/S, DK | MQG |
| Feb 1, 1999 | K983642 | COOK MINI-INCUBATOR Cook Ob/Gyn | MQG |
| Dec 16, 1998 | K983609 | COOK TEST TUBE HEATER Cook Ob/Gyn | MQG |
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