Accessory, Assisted Reproduction

FDA product code MQG · 44 cleared devices

Class 2 Obstetrics/Gynecology

Regulation: 21 CFR 884.6120
Review panel: OB
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1998-12-16 – 2026-08-19

MQG 2026-08-19

Wallace® Aspiration Pump (WAPV1); Wallace® Pump Filter Connector (WFC); Wallace® Vacuum Connection Kit (WVCK)

Applicant CooperSurgical, Inc.

K number K261083

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MQG 2026-04-28

Vacuum Pump (Model: AD-VPUM-500)

Applicant Sheng Sheng Yi (Beijing) Technology Company Limited

K number K260194

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MQG 2025-05-22

Harioculture TL-16 Time-lapse Incubator

Applicant Hua Yue Medical Technology Co., Ltd.

K number K242684

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MQG 2024-05-07

Embryo Real-time Incubator (TLS301), Embryo Real-time Culture Dish (MC 2004)

Applicant Wuhan Huchuang Union Technology Co., Ltd.

K number K232493

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MQG 2018-06-07

Geri Embryo Incubator with Geri Connect and Geri Assess Software, and Geri Dish

Applicant Genea Biomedx Pty, Ltd.

K number K180188

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MQG 2018-05-11

EmbryoScope+

Applicant Vitrolife A/S

K number K173264

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MQG 2018-04-20

Geri Embryo Incubator and Geri Dish

Applicant Genea Biomedx Pty, Ltd.

K number K180304

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MQG 2017-11-15

Geri Embryo Incubator and Geri Dish

Applicant Genea Biomedx Pty, Ltd.

K number K171736

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MQG 2017-06-13

COOK Vacuum Pump

Applicant William A. Cook Australia Pty. , Ltd.

K number K160753

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MQG 2016-07-18

RI Witness Embryology Heated Plate

Applicant Research Instruments Limited

K number K160504

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MQG 2016-04-22

MIRI TL

Applicant At Medical Uab

K number K151357

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MQG 2012-11-29

PLANER BT37 INCUBATOR

Applicant Planer Plc

K number K121566

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MQG 2011-12-21

EMBRYO VIEWER SOFTWARE

Applicant Unisense Fertilitech A/S

K number K113075

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MQG 2011-08-11

EMBRYOSCOPE

Applicant Unisense Fertilitech A/S

K number K111715

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MQG 2011-02-08

HEAL FORCE CO2 INCUBATOR

Applicant Shanghai Lishen Scientific Equipment Co., Ltd.

K number K101988

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MQG 2011-01-11

EMBRYOSCOPE AND EMBRYOSLIDE

Applicant Unisense Fertilitech A/S

K number K092183

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MQG 2006-10-06

MINITUBE TEMPERATURE CONTROL UNIT SC-2000 + 2045

Applicant Minitube of America, Inc.

K number K050197

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MQG 2005-09-08

ZIVF-AIRE

Applicant Zander Medical Supplies, Inc.

K number K041952

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MQG 2004-03-19

KRYO ART CONTROLLED RATE FREEZER

Applicant Planer Plc

K number K032086

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MQG 2003-08-29

BINDER CO2 INCUBATOR SERIE CB

Applicant Binder GmbH

K number K032526

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MQG 2003-08-27

CUSTOM PRODUCTS IVF WORKSTATION TYPE WKST-2436, WKST-2448, WKST-2460, WKST-2472 AND WKST-24*72D PLUS ACCESSORIES

Applicant Mid-Atlantic Diagnostics, Inc.

K number K030525

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MQG 2003-03-10

KENDRO HERACELL 240 INCUBATOR

Applicant Kendro Laboratory Products, L.P.

K number K023465

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MQG 2002-08-15

DB1 EMBRYO FREEZE

Applicant Zander Medical Supplies, Inc.

K number K011327

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MQG 2002-06-19

WORKBENCH BY <GENX>

Applicant Genx Intl., Inc.

K number K020560

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MQG 2002-05-15

THERMO FORMA, CRYOMED, CONTROLLED RATE FREEZERS; MODELS # 7456, 7457, 7458,7459,7475,7476

Applicant Thermo Forma, Inc.

K number K021042

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MQG 2002-02-08

PGD-PRE-IMPLANTATION GENETIC DIAGNOSTIC PIPETTES (BIOPSY PIPETTES)

Applicant Cook Urological, Inc.

K number K014160

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MQG 2001-12-14

SANYO CO2 INCUBATORS, MODELS NOS. MCO-17AC, MCO-17AIC, MCO-20AIC,AND MC0-175M

Applicant Sanyo North America Corp.

K number K013703

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MQG 2001-12-14

K-SYSTEMS CULTURE BAG SEALER AND CULTURE BAGS TYPE CBS-1 AND CB-01

Applicant K-Systems, Kivex Biotec , Ltd.

K number K013401

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MQG 2000-12-15

MTG - MINITUB HEATED STAGE SYSTEMS

Applicant Zander Medical Supplies, Inc.

K number K002971

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MQG 2000-11-22

<GENX> CODA INCUBATOR CELLMATE

Applicant <Genx> Intl., Inc.

K number K001600

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MQG 2000-11-21

MINITUB MULTI-PURPOSE CASSETTES

Applicant Zander Medical Supplies, Inc.

K number K002961

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MQG 2000-11-20

RS BIOTECH GALAXY 'R' CO2 INCUBATOR

Applicant Zander Medical Supplies, Inc.

K number K003184

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MQG 2000-11-17

CBS STRAW

Applicant Cryo Bio System

K number K002595

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MQG 2000-11-09

KENDRO HERACELL CO2 INCUBATOR

Applicant Kendro Laboratory Products, L.P.

K number K002805

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MQG 2000-09-15

GENX CODA AIR PURIFICATION SYSTEM

Applicant <Genx> Intl., Inc.

K number K001486

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MQG 2000-07-12

FORMA SCIENTIFIC DIRECT HEAT INCUBATORS

Applicant Thermoquest Corp.

K number K001524

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MQG 2000-02-29

CRAFT DUO-VAC SUCTION UNIT AND CRAFT SUCTION UNIT

Applicant Rocket Medical Plc

K number K000394

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MQG 1999-10-27

COOK ULTRA QUIET VACUUM PUMP & REGULATOR

Applicant Cook Urological, Inc.

K number K992070

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MQG 1999-08-05

HOFFMAN IVF-1

Applicant (Arms) Hoffman Surgical Equipment, Ivf Division

K number K991216

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MQG 1999-07-19

FORMA SCIENTIFIC UNIVERSAL WATER-JACKETED INCUBATOR

Applicant Thermoquest Corp.

K number K991408

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MQG 1999-07-08

THERMOPLATE

Applicant Tokai Hit Co., Ltd.

K number K991263

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MQG 1999-06-29

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

Applicant Henning Knudsen Engineering A/S

K number K991229

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MQG 1999-02-01

COOK MINI-INCUBATOR

Applicant Cook Ob/Gyn

K number K983642

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MQG 1998-12-16

COOK TEST TUBE HEATER

Applicant Cook Ob/Gyn

K number K983609

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