FDA 510(k) Applications for Medical Device Product Code "MQG"
(Accessory, Assisted Reproduction)

FDA 510(k) Number Applicant Device Name Decision Date
K991216 (ARMS) HOFFMAN SURGICAL EQUIPMENT, IVF DIVISION HOFFMAN IVF-1 08/05/1999
K001600 INTL., INC. CODA INCUBATOR CELLMATE 11/22/2000
K001486 INTL., INC. GENX CODA AIR PURIFICATION SYSTEM 09/15/2000
K151357 AT MEDICAL UAB MIRI TL 04/22/2016
K133742 AT MEDICAL UAB XQ-1 INCUBATOR 04/23/2014
K032526 BINDER GMBH BINDER CO2 INCUBATOR SERIE CB 08/29/2003
K983642 COOK OB/GYN COOK MINI-INCUBATOR 02/01/1999
K983609 COOK OB/GYN COOK TEST TUBE HEATER 12/16/1998
K992070 COOK UROLOGICAL, INC. COOK ULTRA QUIET VACUUM PUMP & REGULATOR 10/27/1999
K014160 COOK UROLOGICAL, INC. PGD-PRE-IMPLANTATION GENETIC DIAGNOSTIC PIPETTES (BIOPSY PIPETTES) 02/08/2002
K002595 CRYO BIO SYSTEM CBS STRAW 11/17/2000
K171736 Genea Biomedx Pty Ltd Geri Embryo Incubator and Geri Dish 11/15/2017
K180304 Genea Biomedx Pty Ltd Geri Embryo Incubator and Geri Dish 04/20/2018
K180188 Genea Biomedx Pty Ltd Geri Embryo Incubator with Geri Connect and Geri Assess Software, and Geri Dish 06/07/2018
K020560 GENX INTL., INC. WORKBENCH BY 06/19/2002
K991229 HENNING KNUDSEN ENGINEERING A/S 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 06/29/1999
K013401 K-SYSTEMS, KIVEX BIOTEC LTD. K-SYSTEMS CULTURE BAG SEALER AND CULTURE BAGS TYPE CBS-1 AND CB-01 12/14/2001
K023465 KENDRO LABORATORY PRODUCTS, L.P. KENDRO HERACELL 240 INCUBATOR 03/10/2003
K002805 KENDRO LABORATORY PRODUCTS, L.P. KENDRO HERACELL CO2 INCUBATOR 11/09/2000
K030525 MID-ATLANTIC DIAGNOSTICS, INC. CUSTOM PRODUCTS IVF WORKSTATION TYPE WKST-24*36, WKST-24*48, WKST-24*60, WKST-24*72 AND WKST-24*72D PLUS ACCESSORIES 08/27/2003
K050197 MINITUBE OF AMERICA, INC MINITUBE TEMPERATURE CONTROL UNIT SC-2000 + 2045 10/06/2006
K132870 ORIGIO, INC Origio Gas Line Filter 05/07/2014
K032086 PLANER PLC KRYO ART CONTROLLED RATE FREEZER 03/19/2004
K121566 PLANER PLC PLANER BT37 INCUBATOR 11/29/2012
K160504 RESEARCH INSTRUMENTS LIMITED RI Witness Embryology Heated Plate 07/18/2016
K000394 ROCKET MEDICAL PLC CRAFT DUO-VAC SUCTION UNIT AND CRAFT SUCTION UNIT 02/29/2000
K013703 SANYO NORTH AMERICA CORP. SANYO CO2 INCUBATORS, MODELS NOS. MCO-17AC, MCO-17AIC, MCO-20AIC,AND MC0-175M 12/14/2001
K101988 SHANGHAI LISHEN SCIENTIFIC EQUIPMENT CO., LTD HEAL FORCE CO2 INCUBATOR 02/08/2011
K021042 THERMO FORMA, INC. THERMO FORMA, CRYOMED, CONTROLLED RATE FREEZERS; MODELS # 7456, 7457, 7458,7459,7475,7476 05/15/2002
K001524 THERMOQUEST CORP. FORMA SCIENTIFIC DIRECT HEAT INCUBATORS 07/12/2000
K991408 THERMOQUEST CORP. FORMA SCIENTIFIC UNIVERSAL WATER-JACKETED INCUBATOR 07/19/1999
K991263 TOKAI HIT CO., LTD. THERMOPLATE 07/08/1999
K113075 UNISENSE FERTILITECH A/S EMBRYO VIEWER SOFTWARE 12/21/2011
K111715 UNISENSE FERTILITECH A/S EMBRYOSCOPE 08/11/2011
K092183 UNISENSE FERTILITECH A/S EMBRYOSCOPE AND EMBRYOSLIDE 01/11/2011
K133712 UNISENSE FERTILITECH A/S EMBRYOVIEWER SOFTWARE 08/08/2014
K173264 Vitrolife A/S EmbryoScope+ 05/11/2018
K160753 WILLIAM A. COOK AUSTRALIA PTY LTD COOK Vacuum Pump 06/13/2017
K011327 ZANDER MEDICAL SUPPLIES, INC. DB1 EMBRYO FREEZE 08/15/2002
K002961 ZANDER MEDICAL SUPPLIES, INC. MINITUB MULTI-PURPOSE CASSETTES 11/21/2000
K002971 ZANDER MEDICAL SUPPLIES, INC. MTG - MINITUB HEATED STAGE SYSTEMS 12/15/2000
K003184 ZANDER MEDICAL SUPPLIES, INC. RS BIOTECH GALAXY 'R' CO2 INCUBATOR 11/20/2000
K041952 ZANDER MEDICAL SUPPLIES, INC. ZIVF-AIRE 09/08/2005


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