FDA.reportPublic FDA data

International-Biomedical

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
16253921000058335INTERNATIONAL BIOMEDICAL, LTD.1N2026-01-018206 Cross Park Dr AUSTIN TX US 78754
16294971629497INTERNATIONAL BIOMEDICAL, LTD.1N2020-04-252725 NORTH MAIN ST. CLEBURNE TX US 76033

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
00850018561099Wee Sight Transilluminator - 9898056037615128730033sales@int-bio.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
32801502847955K951739PUMP/BLOOD CHEMISTRY MONITORLZF1996-02-28
32801751487563K922997VIA 1-01 INFUSION PUMP/BLOOD CHEM. SYST. -- MOD.LZF1994-01-11
32801466023379K905234TXP TRANSPORTER FAMILY AND RELATED ACCESSORIESCBK1991-06-13
32801237178322K870173LAVABED SYSTEM & CHAMBER, LAVAPAK TEMP. CONTROLBTT1987-04-03
32801310751678K221653InfaTherm Disposable Infant Warming MattressIMD2022-10-06
32801695076966K221154Infant Heel WarmerTM; Heel Snuggler®MPO2022-10-07
32801890851336K220742NxtGen Infant Transport IncubatorFPL2022-07-15
32801818122144K193481AeroNOx 2.0 Nitric Oxide Titration & Monitoring SystemMRN2020-03-10
32801511674240K182956Puffin Lite Infant Resuscitation SystemBTL2019-01-18
32801224516424K173516NuBorne Infant WarmerFMT2018-08-17
32801356138626K160238Airborne Phototherapy LightLBI2016-06-14
32801737743687K140707LIFEBORNE INFANT RESUSCITATORBTL2014-05-28
32801068557775K103527AVIATOR TRANSPORT INCUBATOR WITH MASIMO PULSEOX, AVIATOR TRANSPORT INCUBATOR WITH NELLCOR PULSEOXFPL2011-04-15
32801946380101K103525A750I TRANSPORT INCUBATOR WITH MASIMO PLUSEOX, A750I TRANSPORT INCUBATOR WITH NELLOR PULSEOXFPL2011-05-11
32801836219120K103524VOYAGER TRANSPORT INCUBATOR WITH MASIMO PULSEOX, VOYAGER TRANSPORT INCUBATOR WITH NELLCOR PULSEOXFPL2011-04-15
32801366156550K103523185A+ TRANSPORT INCUBATOR WITH MASIMO PULSEOX, 185A+ TRANSPORT INCUBATOR WITH NELLCOR PULSEOXFPL2011-05-11
32801730327004K093260AERONOX NITRIC OXIDE TITRATION & MONITORING SYSTEMMRN2009-12-16
32801487731042K081399AVIATOR TRANSPORT INCUBATORFPL2008-06-06
32801325472753K031096MODIFICATION TO TRANSPORT INCUBATOR 185FPL2003-06-24
32801943230589K022876MODIFICATION TO INFANT LIFE SUPPORT MODULE-20FPL2002-09-11
32791260242681K022873POWDER-FREE RADIATION ATTENUATING NEOPRENE SURGICAL GLOVE (BLACK)KGO2003-03-21
32791424934958K022873POWDER-FREE RADIATION ATTENUATING NEOPRENE SURGICAL GLOVE (BLACK)KGO2003-03-21
32801985181199K000653AERONOX UNIVERSAL, MODEL P/N 360000, AERONOX BEDSIDE, MODEL P/N 360001, AERONOX TRANSPORT TRANSPORT, MODEL P/N 360002MRN2000-08-04
32801196786713
32801276962411
32801776525076
32801819623241
32801837213438

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
FPL82022-07-15
MRN32020-03-10
BTL22019-01-18
KGO22003-03-21
LZF21996-02-28
MPO12022-10-07
IMD12022-10-06
FMT12018-08-17
LBI12016-06-14
CBK11991-06-13
BTT11987-04-03

PMN#

GUDID#