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 |