Company ยท US
<Genx> Intl., Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1996 to 2012. Name variants (Inc, Corp, punctuation) are merged.
32510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| MQL | Media, Reproductive | 20 |
| MQE | Needle, Assisted Reproduction | 3 |
| MQG | Accessory, Assisted Reproduction | 3 |
| MQK | Labware, Assisted Reproduction | 2 |
| MFD | Cannula, Intrauterine Insemination | 1 |
| MOL | Condom, Synthetic | 1 |
| MQF | Catheter, Assisted Reproduction | 1 |
| MQJ | Micromanipulators And Microinjectors, Assisted Reproduction | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 3, 2012 | K112083 | LIFEGLOBAL TOTAL, TOTAL FOR FERTILIZATION, TOTAL W/HEPES, HTF TOTAL, HTF TOTAL W/HEPES <Genx> Intl., Inc. | MQL |
| Jan 14, 2011 | K092963 | GLOBAL BLASTOCYST VITRIFICATION KIT & VITRIFICATION THAWING KIT - BASED ON S3 Genx Intl., Inc. | MQL |
| Jun 3, 2010 | K092667 | GLOBAL DMSO BLASTOCYST VITRIFICATION KIT AND WARMING KIT Genx Intl., Inc. | MQL |
| Apr 5, 2010 | K092578 | LIFEGLOBAL PROTEIN SUPPLEMENT Genx Intl., Inc. | MQL |
| Apr 24, 2009 | K083509 | LIFEGLOBAL HUMAN SERUM ALBUMIN LG HSA Genx Intl., Inc. | MQL |
| Aug 13, 2008 | K080395 | SUNIVF DISHES <Genx> Intl., Inc. | MQK |
| Jul 3, 2007 | K070689 | LG SPERM FREEZING Genx Intl., Inc. | MQL |
| May 19, 2006 | K053552 | GLOBAL FERTILIZATION, EMBRYO CULTURE AND TRANSFER MEDIA <Genx> Intl., Inc. | MQL |
| May 9, 2006 | K053551 | MICROMANIPULATION MEDIA SYSTEM, LG HYALURONIDASE AND LG PARAFFIN OIL <Genx> Intl., Inc. | MQL |
| Jun 25, 2004 | K040530 | MEDIA CULTURE SYSTEM <Genx> Intl., Inc. | MQL |
| Nov 26, 2002 | K023033 | ALLGRAD WASH (HERPES BUFFERED WASHING MEDIUM) <Genx> Intl., Inc. | MQL |
| Aug 30, 2002 | K022590 | PVP (POLYVINYLPYRROLIDONE) <Genx> Intl., Inc. | MQL |
| Aug 28, 2002 | K022547 | ACIDIFIED TYRODES SOLUTION <Genx> Intl., Inc. | MQL |
| Aug 28, 2002 | K022352 | HTF PLUS WITH HEPES (HTF WITH NON-ESSENTIAL AMINO ACIDS) <Genx> Intl., Inc. | MQL |
| Aug 28, 2002 | K022334 | HTF PLUS - HTF WITH NON-ESSENTIAL AMINO ACIDS <Genx> Intl., Inc. | MQL |
| Aug 26, 2002 | K022330 | ALLGRAD 45 AND 90 CELL SEPARATION MEDIA <Genx> Intl., Inc. | MQL |
| Aug 23, 2002 | K022335 | ALLGRAD AND ALLGRAD100 <Genx> Intl., Inc. | MQL |
| Aug 23, 2002 | K022332 | LITE MINERAL OIL <Genx> Intl., Inc. | MQL |
| Jun 19, 2002 | K020560 | WORKBENCH BY <GENX> Genx Intl., Inc. | MQG |
| May 2, 2001 | K010183 | GLOBAL BY <GENX> BLASTOCYST MEDIA <Genx> Intl., Inc. | MQL |
| Nov 22, 2000 | K001600 | <GENX> CODA INCUBATOR CELLMATE <Genx> Intl., Inc. | MQG |
| Sep 15, 2000 | K001486 | GENX CODA AIR PURIFICATION SYSTEM <Genx> Intl., Inc. | MQG |
| Feb 14, 2000 | K993884 | GENX MICROTOOLS <Genx> Intl., Inc. | MQJ |
| Feb 14, 2000 | K993881 | GENX CULTURE DISH <Genx> Intl., Inc. | MQK |
| Sep 9, 1999 | K991266 | <GENX> EMBRYO TRANSFER CATHETER CC GLIDER <Genx> Intl., Inc. | MQF |
| Sep 9, 1999 | K991264 | <GENX> SINGLE LUMEN SIDEPORT NEEDLE <Genx> Intl., Inc. | MQE |
| Sep 9, 1999 | K991262 | <GEN>SINGLE LUMEN NEEDLE <Genx> Intl., Inc. | MQE |
| Sep 9, 1999 | K991022 | <GENX> SPERM WASHING MEDIA <Genx> Intl., Inc. | MQL |
| Sep 9, 1999 | K991020 | <GENX> DOUBLE LUMEN NEEDLE <Genx> Intl., Inc. | MQE |
| Jul 19, 1999 | K991173 | <GENX> FERTILIZATION MEDIA-HTF <Genx> Intl., Inc. | MQL |
| Nov 26, 1996 | K962816 | SPERM PREPARATION MEDIA Genx Intl., Inc. | MOL |
| Oct 21, 1996 | K963031 | GENXCATHETER Genx Intl., Inc. | MFD |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||