<Genx> Intl., Inc.
Madison, CT, US
<Genx> Intl., Inc. appears in FDA device records in Madison, CT. FDA records list 32 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 32
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 32 510(k) clearances for <Genx> Intl., Inc. between 1996 and 2012. The busiest year on record is 2002, with 9. The most recent is 2012, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1996 | 2 |
| 1999 | 6 |
| 2000 | 4 |
| 2001 | 1 |
| 2002 | 9 |
| 2004 | 1 |
| 2006 | 2 |
| 2007 | 1 |
| 2008 | 1 |
| 2009 | 1 |
| 2010 | 2 |
| 2011 | 1 |
| 2012 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K112083 | LIFEGLOBAL TOTAL, TOTAL FOR FERTILIZATION, TOTAL W/HEPES, HTF TOTAL, HTF TOTAL W/HEPES | MQL | Substantially Equivalent | |
| K092963 | GLOBAL BLASTOCYST VITRIFICATION KIT & VITRIFICATION THAWING KIT - BASED ON S3 | MQL | Substantially Equivalent | |
| K092667 | GLOBAL DMSO BLASTOCYST VITRIFICATION KIT AND WARMING KIT | MQL | Substantially Equivalent | |
| K092578 | LIFEGLOBAL PROTEIN SUPPLEMENT | MQL | Substantially Equivalent | |
| K083509 | LIFEGLOBAL HUMAN SERUM ALBUMIN LG HSA | MQL | Substantially Equivalent | |
| K080395 | SUNIVF DISHES | MQK | Substantially Equivalent | |
| K070689 | LG SPERM FREEZING | MQL | Substantially Equivalent | |
| K053552 | GLOBAL FERTILIZATION, EMBRYO CULTURE AND TRANSFER MEDIA | MQL | Substantially Equivalent | |
| K053551 | MICROMANIPULATION MEDIA SYSTEM, LG HYALURONIDASE AND LG PARAFFIN OIL | MQL | Substantially Equivalent | |
| K040530 | MEDIA CULTURE SYSTEM | MQL | Substantially Equivalent | |
| K023033 | ALLGRAD WASH (HERPES BUFFERED WASHING MEDIUM) | MQL | Substantially Equivalent | |
| K022590 | PVP (POLYVINYLPYRROLIDONE) | MQL | Substantially Equivalent | |
| K022547 | ACIDIFIED TYRODES SOLUTION | MQL | Substantially Equivalent | |
| K022352 | HTF PLUS WITH HEPES (HTF WITH NON-ESSENTIAL AMINO ACIDS) | MQL | Substantially Equivalent | |
| K022334 | HTF PLUS - HTF WITH NON-ESSENTIAL AMINO ACIDS | MQL | Substantially Equivalent | |
| K022330 | ALLGRAD 45 AND 90 CELL SEPARATION MEDIA | MQL | Substantially Equivalent | |
| K022335 | ALLGRAD AND ALLGRAD100 | MQL | Substantially Equivalent | |
| K022332 | LITE MINERAL OIL | MQL | Substantially Equivalent | |
| K020560 | WORKBENCH BY <GENX> | MQG | Substantially Equivalent | |
| K010183 | GLOBAL BY <GENX> BLASTOCYST MEDIA | MQL | Substantially Equivalent | |
| K001600 | <GENX> CODA INCUBATOR CELLMATE | MQG | Substantially Equivalent | |
| K001486 | GENX CODA AIR PURIFICATION SYSTEM | MQG | Substantially Equivalent | |
| K993884 | GENX MICROTOOLS | MQJ | Substantially Equivalent | |
| K993881 | GENX CULTURE DISH | MQK | Substantially Equivalent | |
| K991266 | <GENX> EMBRYO TRANSFER CATHETER CC GLIDER | MQF | Substantially Equivalent | |
| K991264 | <GENX> SINGLE LUMEN SIDEPORT NEEDLE | MQE | Substantially Equivalent | |
| K991262 | <GEN>SINGLE LUMEN NEEDLE | MQE | Substantially Equivalent | |
| K991022 | <GENX> SPERM WASHING MEDIA | MQL | Substantially Equivalent | |
| K991020 | <GENX> DOUBLE LUMEN NEEDLE | MQE | Substantially Equivalent | |
| K991173 | <GENX> FERTILIZATION MEDIA-HTF | MQL | Substantially Equivalent | |
| K962816 | SPERM PREPARATION MEDIA | MOL | Substantially Equivalent | |
| K963031 | GENXCATHETER | MFD | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain