Oxygen
Oxygen
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3012050423 | 3012050423 | MEDAS, INC. | 1 | N | 2026-01-01 | 20855 NE 16TH Avenue C21 Miami FL US 33179 |
| 3029779046 | 3029779046 | Medasense Biometrics Inc. | 1 | Y | 2026-01-01 | 2436 Emrick Boulevard Bethlehem PA US 18020 |
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00819667020746 | MEDADV - ONSET FEMORAL INTRODUCER KIT 6 Fr | +1(786) 832-0459 | customerservice@medasusa.com |
| 00819667020753 | MEDADV - ONSET RADIAL INTRODUCER KIT 5 Fr | +1(786)832-0459 | customerservice@medausa.com |
| 07290017287027 | PMD-200 Single Use Sensor - MEK-0002 | 610-317-1670 | info@medasense.com |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 202409 | 1557798459 | K973477 | BIOSENSORS EMBOLECTOMY CATHETER | DXE | 1998-09-04 |
| 202409 | 1987099392 | K241581 | Hemodialysis Catheter | MSD | 2025-05-16 |
| 202409 | 2053313042 | K211393 | Selethru(TM) NC PTCA Balloon Dilatation Catheter | LOX | 2021-07-02 |
| 202409 | 1008026326 | K180797 | Xcess Guiding Catheter | DQY | 2018-12-14 |
| 202409 | 1664035970 | K180177 | |||
| 202409 | 1177191858 | K172331 | Type I, Type II, Type III, Type IV | DYB | 2018-03-02 |
| 202409 | 1496803028 | K172099 | Shoocin Introducer Kit | DYB | 2017-10-05 |
| 202409 | 2066823609 | K171290 | Vela RX PTA Balloon Dilatation Catheter | LIT | 2017-07-19 |
| 202409 | 1466658526 | K142797 | I.V. Catheter | FOZ | 2015-06-18 |
| 202409 | 1177096312 | K142359 | Vasc Band hemostat | DXC | 2014-10-23 |
| 202409 | 1722835280 | K141707 | ULTRASKIN HYDROPHILIC GUIDE WIRE | DQX | 2015-01-21 |
| 202409 | 1779248722 | K141354 | NAVAJO PTA BALLOON DILATATION CATHETER | DQY | 2015-01-30 |
| 202409 | 1934375404 | K140768 | TYPE I BRILLIANT INTRODUCER KIT, TYPE II BRILLIANT INTRODUCER KIT, TYPE III BRILLIANT INTRODUCER KIT, TYPE IV BRILLIANT | DYB | 2014-11-25 |
| 202409 | 1604299048 | K140667 | WELL LEAD HYDROPHILIC SILICONE FOLEY CATHETER | EZL | 2014-12-15 |
| 202409 | 1995553554 | K132802 | MOTEX POWDERED NITRILE SURGICAL GLOVES | KGO | 2014-05-21 |
| 202409 | 1213340060 | K131303 | DISPOSABLE CIRCULAR STAPLER | GDW | 2013-06-11 |
| 202409 | 2027322233 | K130212 | SAFETY HYPODERMIC NEEDLES WITH/WITHOUT SYRINGE | FMI | 2013-11-20 |
| 202409 | 1891601908 | K123475 | SHOOCIN INTRODUCER KIT | DYB | 2014-02-03 |
| 202409 | 1503663603 | K123473 | HOPER PTCA BALLOON CATHETER | LOX | 2013-08-13 |
| 202409 | 1932236545 | K123126 | MOTEX POLYISOPRENE POWDER-FREE SURGICAL GLOVES MODEL # 6412(6432) AND # 6512(6532) | KGO | 2014-06-04 |
| 202409 | 1329191513 | K122557 | MOTEX POWDER-FREE NITRILE SURGICAL GLOVES | KGO | 2013-10-03 |
| 202409 | 1689463292 | K113622 | ORION II CT CVC | FOZ | 2012-05-18 |
| 202409 | 1029302182 | K102833 | DISPOSABLE HEMODIALYSIS ACCESS CATHETER SETS | MPB | 2011-11-18 |
| 202409 | 1844645074 | K100907 | NON-STERILE, POWDER FREE LATEX EXAMINATION GLOVES AND PROTEIN CLAIM (50 MICROGRAMS OR LESS) MODEL: WHITE: X-SMALL, SMALL | LYY | 2010-07-09 |
| 202409 | 1376391928 | K092886 | WELL LEAD ENDOBRONCHIAL TUBES | CBI | 2010-03-11 |
| 202409 | 1570335509 | K092250 | MEDLINE RED RUBBER URETHRAL CATHETER | EYB | 2010-01-21 |
| 202409 | 1650596892 | K091516 | WELL LEAD SILICONE CATHETER WITH TEMPERATURE SENSOR | EZL | 2009-10-16 |
| 202409 | 1567045369 | K090427 | URSA ANGIOGRAPHIC CATHETER | DQO | 2010-01-29 |
| 202409 | 1732153586 | K083687 | BAIXIN INTRAVASCULAR ADMINISTRATION SET | FPA | 2009-06-11 |
| 202409 | 1703072329 | K083686 | BAIXIN DISPOSABLE SYRINGE, MULTIPLE SIZES | FMF | 2009-07-02 |
| 202409 | 1602162972 | K082815 | WELL LEAD SILICONE AND LATEX FOLEY CATHETERS | EZL | 2008-10-08 |
| 202409 | 1750236425 | K073383 | WELL LEAD REINFORCED ENDOTRACHEAL TUBE | BTR | 2008-07-10 |
| 202409 | 1268630354 | K070451 | ABLE CENTRAL VENOUS CATHETER | FOZ | 2007-07-31 |
| 202409 | 2032320693 | K063757 | MOTEX POWDER-FREE SURGICAL GLOVES AND LIGHTLY POWDERED SURGICAL GLOVES | KGO | 2007-07-27 |
| 202409 | 1368844394 | K053519 | SAFETY SYRINGE | MEG | 2006-08-11 |
| 202409 | 2037913101 | K042683 | WELL LEAD ENDOTRACHEAL TUBE | BTR | 2005-02-18 |
| 202409 | 1031218610 | K033210 | BIOTEQ DOUBLE PIGTAIL URETERAL STENT SET | FAD | 2004-12-30 |
| 202409 | 1117240135 | K030207 | NITRILE POWDER-FREE EXAMINATION GLOVES, PROBLUE, #7235 7 #7735 | LZA | 2003-05-02 |
| 202409 | 1062258390 | K020837 | MOTEX LATEX EXAMINATION GLOVES, POWDER-FREE | LYY | 2002-12-02 |
| 202409 | 1029477703 | ||||
| 202409 | 1088190845 | ||||
| 202409 | 1092649944 | ||||
| 202409 | 1131720151 | ||||
| 202409 | 1255263587 | ||||
| 202409 | 1269788932 | ||||
| 202409 | 1288517661 | ||||
| 202409 | 1341398190 | ||||
| 202409 | 1376246668 | ||||
| 202409 | 1382895571 | ||||
| 202409 | 1564335791 | ||||
| 202409 | 1674952965 | ||||
| 202409 | 1728257715 | ||||
| 202409 | 1850714582 | ||||
| 202409 | 2063207469 |
| Product code | Registration listing records | Latest decision |
|---|---|---|
| DYB | 4 | 2018-03-02 |
| KGO | 4 | 2014-06-04 |
| FOZ | 3 | 2015-06-18 |
| EZL | 3 | 2014-12-15 |
| LOX | 2 | 2021-07-02 |
| DQY | 2 | 2018-12-14 |
| LYY | 2 | 2010-07-09 |
| BTR | 2 | 2008-07-10 |
| MSD | 1 | 2025-05-16 |
| LIT | 1 | 2017-07-19 |
| DQX | 1 | 2015-01-21 |
| DXC | 1 | 2014-10-23 |
| FMI | 1 | 2013-11-20 |
| GDW | 1 | 2013-06-11 |
| MPB | 1 | 2011-11-18 |
| CBI | 1 | 2010-03-11 |
| DQO | 1 | 2010-01-29 |
| EYB | 1 | 2010-01-21 |
| FMF | 1 | 2009-07-02 |
| FPA | 1 | 2009-06-11 |
| MEG | 1 | 2006-08-11 |
| FAD | 1 | 2004-12-30 |
| LZA | 1 | 2003-05-02 |
| DXE | 1 | 1998-09-04 |
Oxygen
MEDASONICS, INC.
MEDASONICS, INC.
MEDASONICS, INC.
MEDASTAT SCIENTIFIC CORP.
MEDASONICS, INC.
MEDASONICS, INC.
MEDASYS, INC.
MEDASONICS, INC.
MEDASYS, INC.
MEDASONICS, INC.
MEDASONICS, INC.
MEDASONICS, INC.
MEDASTAT SCIENTIFIC CORP.
MEDASONICS, INC.
MEDASONICS, INC.
MEDASTAT SCIENTIFIC CORP.
MEDASONICS, INC.
MEDASONICS, INC.
MEDASONICS, INC.
MEDASONICS, INC.
MEDASONICS, INC.
MEDASONICS, INC.
MEDASONICS, INC.
MEDASONICS, INC.
2018-04-09
2018-04-09
2023-11-15
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