Labware, Assisted Reproduction

FDA product code MQK · 42 cleared devices

Class 2 Obstetrics/Gynecology

Regulation: 21 CFR 884.6160
Review panel: OB
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1999-05-05 – 2025-02-20

MQK 2025-02-20

SperSort™ Sperm Sorting Chip (IPG02)

Applicant Ipreg Incorporation

K number K241626

View details →

MQK 2025-02-03

Minvitro® Vitrification Straw (MVT-VSN series, including MVT-VSNR, MVT-VSNY, MVT-VSNB, MVT-VSNG, MVT-VSNP)

Applicant Guangzhou Hehong Biotech Co., Ltd.

K number K241454

View details →

MQK 2025-01-31

SwimCount® Harvester (1 mL); SwimCount® Harvester (3 mL)

Applicant Motilitycount Aps

K number K241348

View details →

MQK 2024-09-26

cryo-GO Vitrification Device

Applicant Fujifilm Irvine Scientific

K number K241341

View details →

MQK 2024-06-14

G-Vitri™ Vitrification Straw

Applicant Gimbo Medical Technology Shenzhen Co., Ltd.

K number K240002

View details →

MQK 2024-03-14

SpermAlign Sperm Separation Device

Applicant Cytoswim, Ltd.

K number K232980

View details →

MQK 2024-03-08

Nest VT Vitrification Device

Applicant Cook Incorporated

K number K233177

View details →

MQK 2022-10-31

LensHooke CA1 Sperm Separation Device, LensHooke CA0 Sperm Separation Device

Applicant Bonraybio Co., Ltd.

K number K221810

View details →

MQK 2022-03-11

EmbryoSlide+ ic8 dish

Applicant Vitrolife A/S

K number K213869

View details →

MQK 2021-06-04

SureStrip Vitrification Straw, SureLock Vitrification Straw

Applicant Allwin Medical Devices, Inc.

K number K203626

View details →

MQK 2020-12-16

Pasteur Pipette 3mL, Pasteur Pipette 1mL

Applicant Hertart Aps

K number K201213

View details →

MQK 2020-06-25

VitriGuard

Applicant Origio A/S

K number K200815

View details →

MQK 2019-01-04

Rapid-i™ Kit

Applicant Vitrolife Sweden AB

K number K181461

View details →

MQK 2018-11-09

Cryotop®US-flash and Cryotop®US-scoop

Applicant Kitazato Corporation

K number K181469

View details →

MQK 2018-05-04

VitriGuard

Applicant Origio A/S

K number K180740

View details →

MQK 2018-03-08

ZyMot ICSI Sperm Separation Device, ZyMot Multi Sperm Separation Device (850µl, 3ml)

Applicant Dxnow, Inc.

K number K173075

View details →

MQK 2018-02-09

iVitri Straw

Applicant Reprobitech Corp.

K number K172751

View details →

MQK 2017-06-30

iVitri EZ

Applicant Reprobitech Corp.

K number K162640

View details →

MQK 2017-02-16

VitriGuard

Applicant Origio A/S

K number K162833

View details →

MQK 2016-12-14

Cryotec

Applicant Reprolife, Inc.

K number K162051

View details →

MQK 2016-03-14

Cryotop US

Applicant Kitazato Biopharma Co., Ltd.

K number K153027

View details →

MQK 2013-07-03

CULTURE DISH 40 MM, CULTURE DISH 60 MM, MICRO DROPLET CULTURE DISH, 5 WELL CULTURE DISH, CENTRE WELL DISH, ICSI DISH

Applicant Hertart

K number K123641

View details →

MQK 2012-12-19

SEAFORIA SPERM SEPARATION ASSISTANCE SYSTEM

Applicant Lotus Bio, Ltd.

K number K112644

View details →

MQK 2012-12-12

CRYOTOP

Applicant Kitazato Biopharma Co;Ltd

K number K112695

View details →

MQK 2012-07-13

RI MSC (MIGRATION SEDIMENTATION CHAMBER)

Applicant Research Instruments , Ltd.

K number K112413

View details →

MQK 2011-08-11

EEVATM PETRI DISH

Applicant Auxogyn, Inc.

K number K103028

View details →

MQK 2010-12-06

CRYOPETTE

Applicant Mid-Atlantic Diagnostics, Inc.

K number K100596

View details →

MQK 2010-10-06

HSV STRAW

Applicant Cryo Bio System

K number K092398

View details →

MQK 2009-12-23

RAPID-I

Applicant Vitrolife Sweden AB

K number K090832

View details →

MQK 2009-09-18

NUNC IVF CENTERWELL AND ICSI DISHES

Applicant Thermo Fisher Scientific (Nalge Nunc Intl)

K number K090429

View details →

MQK 2008-08-20

BIOGENICS BIOQUAD 4-WELL IVF CULTURE DISH

Applicant Biogenics, Inc.

K number K081896

View details →

MQK 2008-08-13

SUNIVF DISHES

Applicant <Genx> Intl., Inc.

K number K080395

View details →

MQK 2007-05-18

NUNC IVF DISHES AND NUNC IVF 4-WELL DISH

Applicant Nunc A/S

K number K070047

View details →

MQK 2006-04-13

PICSI SPERM SELECTION DEVICE

Applicant Biocoat, Inc.

K number K052457

View details →

MQK 2004-08-12

NUNC IVF MULTIDISH 4 WELLS NUNCLON

Applicant Nunc A/S

K number K040717

View details →

MQK 2000-05-12

PASTEUR PIPET - STERILE 9, PASTEUR PIPET - STERILE 5 3/4, MODELS 16-PP-9, 16-PP-5.75

Applicant Humagen Fertility Diagnostics, Inc.

K number K000915

View details →

MQK 2000-02-18

ESP FOUR WELL TISSUE CULTURE PLATE, ESP SIX WELL TISSUE CULTURE PLATE, ESP MICRO SIX WELL TISSUE CULTURE PLATE, ESP WELL

Applicant Genesis Industries, Inc.

K number K994361

View details →

MQK 2000-02-14

GENX CULTURE DISH

Applicant <Genx> Intl., Inc.

K number K993881

View details →

MQK 1999-07-14

NEWLIFE DISH (ETCHED OR NON-ETCHED, WITH OR WITHOUT LID), MODELS 14-52, 1452E, 1452EL, 1452L

Applicant Humagen Fertility Diagnostics, Inc.

K number K990941

View details →

MQK 1999-05-05

FALCON IVF ROUND DISH

Applicant Becton Dickinson Labware

K number K991253

View details →

MQK 1999-05-05

FALCON IVF ONE WELL DISH

Applicant Becton Dickinson Labware

K number K991251

View details →

MQK 1999-05-05

FALCON IVF FOUR WELL PLATE

Applicant Becton Dickinson Labware

K number K991249

View details →