FDA.reportPublic FDA data

MEDAS, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30120504233012050423MEDAS, INC.1N2026-01-0120855 NE 16TH Avenue C21 Miami FL US 33179
30297790463029779046Medasense Biometrics Inc.1Y2026-01-012436 Emrick Boulevard Bethlehem PA US 18020

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00819667020746MEDADV - ONSET FEMORAL INTRODUCER KIT 6 Fr+1(786) 832-0459customerservice@medasusa.com
00819667020753MEDADV - ONSET RADIAL INTRODUCER KIT 5 Fr+1(786)832-0459customerservice@medausa.com
07290017287027PMD-200 Single Use Sensor - MEK-0002610-317-1670info@medasense.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2024091557798459K973477BIOSENSORS EMBOLECTOMY CATHETERDXE1998-09-04
2024091987099392K241581Hemodialysis CatheterMSD2025-05-16
2024092053313042K211393Selethru(TM) NC PTCA Balloon Dilatation CatheterLOX2021-07-02
2024091008026326K180797Xcess Guiding CatheterDQY2018-12-14
2024091664035970K180177
2024091177191858K172331Type I, Type II, Type III, Type IVDYB2018-03-02
2024091496803028K172099Shoocin Introducer KitDYB2017-10-05
2024092066823609K171290Vela RX PTA Balloon Dilatation CatheterLIT2017-07-19
2024091466658526K142797I.V. CatheterFOZ2015-06-18
2024091177096312K142359Vasc Band hemostatDXC2014-10-23
2024091722835280K141707ULTRASKIN HYDROPHILIC GUIDE WIREDQX2015-01-21
2024091779248722K141354NAVAJO PTA BALLOON DILATATION CATHETERDQY2015-01-30
2024091934375404K140768TYPE I BRILLIANT INTRODUCER KIT, TYPE II BRILLIANT INTRODUCER KIT, TYPE III BRILLIANT INTRODUCER KIT, TYPE IV BRILLIANTDYB2014-11-25
2024091604299048K140667WELL LEAD HYDROPHILIC SILICONE FOLEY CATHETEREZL2014-12-15
2024091995553554K132802MOTEX POWDERED NITRILE SURGICAL GLOVESKGO2014-05-21
2024091213340060K131303DISPOSABLE CIRCULAR STAPLERGDW2013-06-11
2024092027322233K130212SAFETY HYPODERMIC NEEDLES WITH/WITHOUT SYRINGEFMI2013-11-20
2024091891601908K123475SHOOCIN INTRODUCER KITDYB2014-02-03
2024091503663603K123473HOPER PTCA BALLOON CATHETERLOX2013-08-13
2024091932236545K123126MOTEX POLYISOPRENE POWDER-FREE SURGICAL GLOVES MODEL # 6412(6432) AND # 6512(6532)KGO2014-06-04
2024091329191513K122557MOTEX POWDER-FREE NITRILE SURGICAL GLOVESKGO2013-10-03
2024091689463292K113622ORION II CT CVCFOZ2012-05-18
2024091029302182K102833DISPOSABLE HEMODIALYSIS ACCESS CATHETER SETSMPB2011-11-18
2024091844645074K100907NON-STERILE, POWDER FREE LATEX EXAMINATION GLOVES AND PROTEIN CLAIM (50 MICROGRAMS OR LESS) MODEL: WHITE: X-SMALL, SMALLLYY2010-07-09
2024091376391928K092886WELL LEAD ENDOBRONCHIAL TUBESCBI2010-03-11
2024091570335509K092250MEDLINE RED RUBBER URETHRAL CATHETEREYB2010-01-21
2024091650596892K091516WELL LEAD SILICONE CATHETER WITH TEMPERATURE SENSOREZL2009-10-16
2024091567045369K090427URSA ANGIOGRAPHIC CATHETERDQO2010-01-29
2024091732153586K083687BAIXIN INTRAVASCULAR ADMINISTRATION SETFPA2009-06-11
2024091703072329K083686BAIXIN DISPOSABLE SYRINGE, MULTIPLE SIZESFMF2009-07-02
2024091602162972K082815WELL LEAD SILICONE AND LATEX FOLEY CATHETERSEZL2008-10-08
2024091750236425K073383WELL LEAD REINFORCED ENDOTRACHEAL TUBEBTR2008-07-10
2024091268630354K070451ABLE CENTRAL VENOUS CATHETERFOZ2007-07-31
2024092032320693K063757MOTEX POWDER-FREE SURGICAL GLOVES AND LIGHTLY POWDERED SURGICAL GLOVESKGO2007-07-27
2024091368844394K053519SAFETY SYRINGEMEG2006-08-11
2024092037913101K042683WELL LEAD ENDOTRACHEAL TUBEBTR2005-02-18
2024091031218610K033210BIOTEQ DOUBLE PIGTAIL URETERAL STENT SETFAD2004-12-30
2024091117240135K030207NITRILE POWDER-FREE EXAMINATION GLOVES, PROBLUE, #7235 7 #7735LZA2003-05-02
2024091062258390K020837MOTEX LATEX EXAMINATION GLOVES, POWDER-FREELYY2002-12-02
2024091029477703
2024091088190845
2024091092649944
2024091131720151
2024091255263587
2024091269788932
2024091288517661
2024091341398190
2024091376246668
2024091382895571
2024091564335791
2024091674952965
2024091728257715
2024091850714582
2024092063207469

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DYB42018-03-02
KGO42014-06-04
FOZ32015-06-18
EZL32014-12-15
LOX22021-07-02
DQY22018-12-14
LYY22010-07-09
BTR22008-07-10
MSD12025-05-16
LIT12017-07-19
DQX12015-01-21
DXC12014-10-23
FMI12013-11-20
GDW12013-06-11
MPB12011-11-18
CBI12010-03-11
DQO12010-01-29
EYB12010-01-21
FMF12009-07-02
FPA12009-06-11
MEG12006-08-11
FAD12004-12-30
LZA12003-05-02
DXE11998-09-04

NDC#

PMN#

PARAPREP

1993-12-02

MEDASTAT SCIENTIFIC CORP.

DNA FLOR

1983-07-28

MEDASTAT SCIENTIFIC CORP.

GUDID#

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