FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K993881 |
INTL., INC. |
GENX CULTURE DISH |
02/14/2000 |
K080395 |
INTL., INC. |
SUNIVF DISHES |
08/13/2008 |
K203626 |
Allwin Medical Devices, Inc |
SureStrip Vitrification Straw, SureLock Vitrification Straw |
06/04/2021 |
K141663 |
AUXOGYN, INC. |
EEVA DISH (WITH 12 MICROWELLS) |
07/22/2014 |
K103028 |
AUXOGYN, INC. |
EEVATM PETRI DISH |
08/11/2011 |
K991249 |
BECTON DICKINSON LABWARE |
FALCON IVF FOUR WELL PLATE |
05/05/1999 |
K991251 |
BECTON DICKINSON LABWARE |
FALCON IVF ONE WELL DISH |
05/05/1999 |
K991253 |
BECTON DICKINSON LABWARE |
FALCON IVF ROUND DISH |
05/05/1999 |
K052457 |
BIOCOAT, INC. |
PICSI SPERM SELECTION DEVICE |
04/13/2006 |
K081896 |
BIOGENICS, INC. |
BIOGENICS BIOQUAD 4-WELL IVF CULTURE DISH |
08/20/2008 |
K122982 |
BIOTECH, INC. |
CRYOLOCK |
01/09/2014 |
K221810 |
Bonraybio Co., LTD. |
LensHooke CA1 Sperm Separation Device, LensHooke CA0 Sperm Separation Device |
10/31/2022 |
K092398 |
CRYO BIO SYSTEM |
HSV STRAW |
10/06/2010 |
K173075 |
DxNow, Inc. |
ZyMot ICSI Sperm Separation Device, ZyMot Multi Sperm Separation Device (850╡l, 3ml) |
03/08/2018 |
K994361 |
GENESIS INDUSTRIES, INC. |
ESP FOUR WELL TISSUE CULTURE PLATE, ESP SIX WELL TISSUE CULTURE PLATE, ESP MICRO SIX WELL TISSUE CULTURE PLATE, ESP WELL |
02/18/2000 |
K123641 |
HERTART |
CULTURE DISH 40 MM, CULTURE DISH 60 MM, MICRO DROPLET CULTURE DISH, 5 WELL CULTURE DISH, CENTRE WELL DISH, ICSI DISH |
07/03/2013 |
K150756 |
HERTART |
Micro well group culture dish, 9-well; Micro well group culture dish, 16-well |
07/20/2015 |
K201213 |
HertART Aps |
Pasteur Pipette 3mL, Pasteur Pipette 1mL |
12/16/2020 |
K990941 |
HUMAGEN FERTILITY DIAGNOSTICS, INC. |
NEWLIFE DISH (ETCHED OR NON-ETCHED, WITH OR WITHOUT LID), MODELS 14-52, 1452E, 1452EL, 1452L |
07/14/1999 |
K000915 |
HUMAGEN FERTILITY DIAGNOSTICS, INC. |
PASTEUR PIPET - STERILE 9, PASTEUR PIPET - STERILE 5 3/4, MODELS 16-PP-9, 16-PP-5.75 |
05/12/2000 |
K112695 |
KITAZATO BIOPHARMA CO;LTD |
CRYOTOP |
12/12/2012 |
K153027 |
KITAZATO BIOPHARMA CO., LTD. |
Cryotop US |
03/14/2016 |
K140072 |
KITAZATO BIOPHARMA CO., LTD. |
CRYOTOP(R) SC |
04/03/2014 |
K181469 |
Kitazato Corporation |
Cryotop«US-flash and Cryotop«US-scoop |
11/09/2018 |
K112644 |
LOTUS BIO LTD |
SEAFORIA SPERM SEPARATION ASSISTANCE SYSTEM |
12/19/2012 |
K133295 |
MENICON CO., LTD. NEW BUSINESS DIVISION |
QUALIS |
06/18/2014 |
K100596 |
MID-ATLANTIC DIAGNOSTICS, INC. |
CRYOPETTE |
12/06/2010 |
K131145 |
NIDACON INTERNATIONAL AB |
PROINSERT |
02/20/2014 |
K070047 |
NUNC A/S |
NUNC IVF DISHES AND NUNC IVF 4-WELL DISH |
05/18/2007 |
K040717 |
NUNC A/S |
NUNC IVF MULTIDISH 4 WELLS NUNCLON |
08/12/2004 |
K162833 |
ORIGIO A/S |
VitriGuard |
02/16/2017 |
K180740 |
ORIGIO a/s |
VitriGuard |
05/04/2018 |
K200815 |
ORIGIO a/s |
VitriGuard |
06/25/2020 |
K162640 |
REPROBITECH CORP. |
iVitri EZ |
06/30/2017 |
K172751 |
Reprobitech Corp. |
iVitri Straw |
02/09/2018 |
K162051 |
REPROLIFE INC. |
Cryotec |
12/14/2016 |
K112413 |
RESEARCH INSTRUMENTS LTD. |
RI MSC (MIGRATION SEDIMENTATION CHAMBER) |
07/13/2012 |
K090429 |
THERMO FISHER SCIENTIFIC (NALGE NUNC INTL) |
NUNC IVF CENTERWELL AND ICSI DISHES |
09/18/2009 |
K150961 |
VITROLIFE A/S |
EmbryoSlide Culture Dish |
12/04/2015 |
K213869 |
Vitrolife A/S |
EmbryoSlide+ ic8 dish |
03/11/2022 |
K090832 |
VITROLIFE SWEDEN AB |
RAPID-I |
12/23/2009 |
K140207 |
VITROLIFE SWEDEN AB |
RAPID-I KIT |
12/18/2014 |
K181461 |
Vitrolife Sweden AB |
Rapid-iÖ Kit |
01/04/2019 |