Panels › Obstetrics/Gynecology › Product code MQH · Class 2
Microtools, Assisted Reproduction (Pipettes)
Regulation 884.6130
1510(k)s in 12 months (27 all time)
0recalls in 12 months (4 all time)
4recalls that name a 510(k)
Top companies in MQH
| Company | 510(k)s | Recalls |
|---|---|---|
| Cook Vascular Inc. | 0 | 3 |
| Research Instruments , Ltd. | 3 | 0 |
| Cook Incorporated | 2 | 0 |
| Cook Urological, Inc. | 2 | 0 |
| Humagen Fertility Diagnostics, Inc. | 2 | 0 |
| Mid-Atlantic Diagnostics, Inc. | 2 | 0 |
| Sunlight Medical, Inc. | 2 | 0 |
| Swemed Lab International AB | 2 | 0 |
| Allwin Medical Devices, Inc. | 1 | 0 |
| Brinkmann Instruments, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 9, 2026 | K261234 | The D-Tip Denudation Pipette Allwin Medical Devices, Inc. | MQH |
| Jul 3, 2025 | K250838 | Denudation Pipettes Guangzhou Pinzhi Medical Device Co., Ltd., CN | MQH |
| Jan 28, 2020 | K192146 | V-DENUPET Vitromed GmbH, DE | MQH |
| Jan 23, 2017 | K161275 | EZ-Tip Singles, EZ-Tip Vial of 20, EZ-Grip Research Instruments Limited, GB | MQH |
| Apr 11, 2016 | K152581 | LifeGlobal Micro Tips Life Global Group, LLC | MQH |
| Jan 8, 2016 | K151018 | Embryo Biopsy Pipette, Polar Body Biopsy Pipette, Testicular Sperm Extraction Pipette Cook Incorporated | MQH |
| Dec 18, 2015 | K150748 | Flexipet Denuding Pipette, Flexipet Manipulation Pipette Cook Incorporated | MQH |
| May 16, 2014 | K133257 | BIOPSY PIPETTES Research Instruments , Ltd., GB | MQH |
| Apr 19, 2011 | K102480 | INJECTION PIPETTE; HOLDING PIPETTE; BIOPSY PIPETTE; DENUDING PIPETTE; PARTIAL ZONA DISSECTION (PZD) PIPETTE; ASSISTED HA Jieying Laboratory, Inc. | MQH |
| Apr 30, 2010 | K092554 | BLASTOMERE BIOPSY PIPETTES, POLAR BODY BIOPSY PIPETTES Sunlight Medical, Inc. | MQH |
| May 19, 2008 | K072600 | INTRACYTOPLASMIC SPERM AND SPERMATID INJECTION, HOLDING, ZONE DRILLING, PARTIAL ZONE DISSECTION AND DENUDING PIPETTES Sunlight Medical, Inc. | MQH |
| Sep 29, 2004 | K041435 | THE STRIPPER PGD Mid-Atlantic Diagnostics, Inc. | MQH |
| Aug 9, 2004 | K041562 | CRYOTIP Irvine Scientific Sales Co., Inc. | MQH |
| Jan 16, 2004 | K033904 | PRE-IMPLANTATION GENETIC DIAGNOSIS PIPETTES (BIOPSY PIPETTES) Cook Urological, Inc. | MQH |
| Jan 16, 2004 | K033903 | MODIFICATION TO INTRACYTOPLASMIC SPERM INJECTION (ISCI), MICRO-INJECTION PIPETTES, HOLDING PIPETTES, DENUDING PIPETTES, Cook Urological, Inc. | MQH |
| Feb 19, 2003 | K024302 | PRECISION CAPILLARIES FOR MICROMANIPULATION Brinkmann Instruments, Inc. | MQH |
| Nov 5, 2002 | K022643 | BLASTOMERE BIOPSY PIPETTE, MODELS H-55530 AND H-55540 Swemed Lab International AB | MQH |
| Feb 11, 2002 | K012811 | BLASTOMERE BIOPSY MICROPIPET, POLAR BODY MICROPIPET, MODELS 10-MBB,10-MBB-B,10-MPB,10-MPB-B Humagen Fertility Diagnostics, Inc. | MQH |
| Aug 18, 2000 | K001615 | HUNTER SCIENTIFIC INJECTION PIPETTES Hunter Scientific Limited, GB | MQH |
| May 16, 2000 | K993699 | THE STRIPPER Mid-Atlantic Diagnostics, Inc. | MQH |
| Sep 13, 1999 | K991388 | ASSISTED HATCHING MICROPIPETTES, DENUDING PIPETTES, HOLDING MICROPIPETTES, ICSI MICROPIPETTES, PARTIAL ZONE DISSECTION M Pacific Andrology, Inc. | MQH |
| Aug 5, 1999 | K991261 | ICSI INJECTION MICROPIPETTE (SPIKED & NON-SPIKED), ICSI HOLDING MICEOPIPETTE, ASSISTED HATCHING/ZONA DRILLING MICROPIPET Research Instruments , Ltd., GB | MQH |
| Jul 19, 1999 | K991700 | SWEMED INTRACYTOPLASMIC SPERM INJECTION (ICSI) MICRO-INJECTION PIPETTES; HOLDING PIPTTES; DENUDING PIPETTES; ASSISTED/ZO Swemed Lab International AB, SE | MQH |
| Jul 19, 1999 | K991104 | MICROTOOLS Conception Technology, Inc. | MQH |
| Jul 14, 1999 | K990847 | INTRACYTOPLASMIC SPERM INJECTION MICROPIPETS (ICSI) SPERMATID ICSI MICROPIPETS, HOLDING MICROPIPETS, ASSISTED HATCHING M Humagen Fertility Diagnostics, Inc. | MQH |
| Jun 8, 1999 | K983713 | PRODIMED MICROINJECTION PIPETTES Prodimed | MQH |
| Feb 5, 1999 | K983596 | INTRACYTOPLASMIC SPERM INJECTION (ICSI) MICRO-INJECTION PIPETTES, HOLDING PIPETTES, DENUDING PIPETTES, ASSISTED HATCHING Cook Ob/Gyn | MQH |
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