ClearanceBrief
Panels › Obstetrics/Gynecology › Product code MQE · Class 2

Needle, Assisted Reproduction

Regulation 884.6100

1510(k)s in 12 months (33 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
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Top companies in MQE

Company510(k)sRecalls
CooperSurgical, Inc.30
<Genx> Intl., Inc.30
Vitrolife Sweden AB30
Rocket Medical Plc20
Sims Portex , Ltd.20
William A. Cook Australia Pty. , Ltd.20
Allwin Medical Devices, Inc.10
Casmed UK10
Cook Ob/Gyn10
Cook Urological, Inc.10
Decided510(k)Device and applicantCode
Jun 15, 2026K253121Giftlife Single Lumen Oocyte Retrieval Needle, Giftlife Double Lumen Oocyte Retrieval Needle
Gimbo Medical Technology Shenzhen Co., Ltd., CN
MQE
Nov 15, 2024K240523VitaVitro® Single Lumen Oocyte Retrieval Needle (ORNS-17G, ORNS-18G), VitaVitro® Double Lumen Oocyte Retrieval Needle (O
Shenzhen Vitavitro Biotech Co., Ltd., CN
MQE
Feb 22, 2024K232163Lotus Single Lumen Ovum Aspiration Needle; Lotus Double Lumen Ovum Aspiration Needle
Zhejiang Horizon Medical Technology Co., Ltd., CN
MQE
Nov 25, 2019K190590Allwin Ovum Pickup Needles (ACE Single Lumen Ovum Pickup Needle, OVUMPICK Double Lumen Ovum Pickup Needle, ACE-FL Single
Allwin Medical Devices, Inc.
MQE
Jun 12, 2019K191291Wallace Dual Lumen Oocyte Recovery System
CooperSurgical, Inc.
MQE
May 10, 2019K182959Wallace Dual Lumen Oocyte Recovery System
CooperSurgical, Inc.
MQE
Jan 12, 2018K171625Single Lumen Ovum Aspiration Needles
Willian A. Cook Australia Pty, Ltd., AU
MQE
Dec 15, 2017K171611Double Lumen Ovum Aspiration Needles
William A. Cook Australia Pty. , Ltd., AU
MQE
Nov 21, 2017K172050Follicle Aspiration Set, Reduced Single Lumen
Vitrolife Sweden AB, SE
MQE
Jul 11, 2017K162881Kitazato OPU Needles
Kitazato Corporation, JP
MQE
Jun 14, 2017K161970Follicle Aspiration Set
Vitrolife Sweden AB, SE
MQE
Aug 7, 2014K141365OTRIEVA TAPERED OVUM ASPIRATION NEEDLE SINGLE LUMEN
William A. Cook Australia Pty. , Ltd., AU
MQE
Nov 26, 2012K112462KITAZATO OPU NEEDLE
Kitazato Medical Co., Ltd.
MQE
Feb 6, 2009K082727FOLLICLE ASPIRATION SET, REDUCED SINGLE LUMEN
Vitrolife Sweden AB, SE
MQE
Oct 7, 2005K051742OOCYTE RETRIEVAL NEEDLE SET, MODELS 917-IH AND 917-SH
Inntec, Inc.
MQE
Dec 9, 2003K032208MONA LISA ASPIRATION NEEDLE
Fertility Technology Resources, Inc.
MQE
Aug 8, 2003K032015EMBRYON ULTRASOUND NEEDLE GUIDE
Rocket Medical Plc, GB
MQE
Jun 26, 2003K031622WALLACE DUAL LUMEN OOCYTE RETRIEVAL SETS
Portex , Ltd., GB
MQE
Jan 22, 2003K023930COOPERSURGICAL OOCYTE RECOVERY NEEDLES
CooperSurgical, Inc.
MQE
Nov 9, 2001K013497FAS SET #4551
Gynetics Medical Products NV
MQE
Aug 3, 2001K012068WALLACE OOCYTE RETRIEVAL SETS 16G, WALLACE OOCYTE RETRIEVAL SET 17G, MODELS MEONS 1633S, MEONS 1733S
Sims Portex , Ltd., GB
MQE
Dec 13, 2000K003056OVARIAL BIOPSY SET 324102-324108; OVARIAL BIOPSY SET 324200-324202; OVARIAL BIOPSY NEEDLE 32218
Labotect Labor-Technik Gottingen, DE
MQE
Apr 19, 2000K000205EMBRYON SINGLE AND DOUBLE LUMEN NEEDLES
Rocket Medical Plc, GB
MQE
Mar 13, 2000K000628WALLACE OOCYTE RETRIEVAL SET-16G, MODEL MEONS1633; WALLACE OOCYTE RETRIEVAL SET-17G, MODEL MEONS1733
Sims Portex , Ltd., GB
MQE
Mar 8, 2000K991271OOCYTE ASPIRATION NEEDLE
Casmed UK, GB
MQE
Mar 1, 2000K994417OVUM PICK-UP NEEDLES WITH AQ COATING, ASPIRATION NEEDLES WITH AQ COATING
Cook Urological, Inc.
MQE
Sep 13, 1999K992308OOCYTE RETRIEVAL NEEDLE SET, MODEL 90138
Lifetek Medical, Inc.
MQE
Sep 9, 1999K991264<GENX> SINGLE LUMEN SIDEPORT NEEDLE
<Genx> Intl., Inc.
MQE
Sep 9, 1999K991262<GEN>SINGLE LUMEN NEEDLE
<Genx> Intl., Inc.
MQE
Sep 9, 1999K991020<GENX> DOUBLE LUMEN NEEDLE
<Genx> Intl., Inc.
MQE
Aug 18, 1999K991273SWEMED FOLLICLE ASPIRATION SET, DOUBLE LUMEN, SINGLE LUMEN, AND LUER NEEDLE
Swemed Lab International AB
MQE
Jun 8, 1999K990913HOC SET WITH VALVE, HOC SET WITHOUT VALVE, HOC SET WITH VALVE - SOFT PLUG, HOC SET WITHOUT VALVE - SOFT PLUG, OPS WITHOU
Laboratoires Prodimed
MQE
Jan 21, 1999K983593OVUM PICK-UP ASPIRATION NEEDLES
Cook Ob/Gyn
MQE

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