FDA.reportPublic FDA data

LABORIE MEDICAL TECHNOLOGIES CORP.

Matched from indexed company URL: LABORIE MEDICAL TECH CORP.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30174483603017448360LABORIE MEDICAL TECHNOLOGIES CORP.1Y2026-01-01180 International Drive Portsmouth NH US 03801
24338282433828LABORIE MEDICAL TECHNOLOGIES, CORP1Y2020-04-25400 AVE D, STE 10 Williston VT US 05495
96814243001438491LABORIE MEDICAL TECHNOLOGIES, Canada ULC1N2020-04-256415 NORTHWEST DR., UNIT 10 MISSISSAUGA Ontario CA L4V 1X1

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
156201332518364K993721UROSTYM BIOFEEDBACK AND STIMULATION ANAL/RECTAL PROBESKPI1999-11-29
2852541964832235K993721UROSTYM BIOFEEDBACK AND STIMULATION ANAL/RECTAL PROBESKPI1999-11-29
156201060413213K990456ANAL 2 ELECTRODE STIMULATION/EMG PROBE - W/STOPKPI1999-03-25
156201481381158K990041UROSTYM BIOFEEDBACK AND STIMULATION PROBESKPI1999-08-05
2852541902864480K990041UROSTYM BIOFEEDBACK AND STIMULATION PROBESKPI1999-08-05
156201441247688K983052PERITRON PERINEOMETER MODEL 9300V OR 9300AHIR1998-10-19
156201693613302K971541VAGINAL 2 ELECTRODE STIMULATION/EMG PROBE - TAMPONKPI1997-06-25
156201093388554K963064ANO-RECTAL MANOMETRY OPTION, MODEL NUMBER UDS-ARMFFX1997-06-05
2852541862540826K963064ANO-RECTAL MANOMETRY OPTION, MODEL NUMBER UDS-ARMFFX1997-06-05
2852541075557148K962009UROSTYMKPI1997-05-20
156201604126123K962009UROSTYMKPI1997-05-20
156201665378448K951805PIPER, MODEL NUMBER UDS-PIPERBFEN1995-07-06
2852541282344823K950016CART, MODE NUMBER UDS-CARTFEN1995-03-30
2852541247752666K942023INFUSION PUMP, MODEL NO. UDP-5FEN1994-07-12
156202034194105K942023INFUSION PUMP, MODEL NO. UDP-5FEN1994-07-12
2852541996142728K241523injeTAK Adjustable Tip Needle (DIS199; DIS201)FBK2024-08-27
2852541092842785K240007Solar Compact (G4-1)FFX2024-05-06
2852541595600874K234107Solar™ Anorectal Manometry Catheter (Model Number: K1210AC-L-2212)KLA2024-04-23
2852541409083868K121014SOLAR GIFFX2012-08-01
2852541639806210K090830LABORIE INJETAK ADJUSTABLE TIP NEEDLE, FLEXIBLE TIP AND RIDGID TIPFBK2009-07-21
156201668348481K090830LABORIE INJETAK ADJUSTABLE TIP NEEDLE, FLEXIBLE TIP AND RIDGID TIPFBK2009-07-21
156201801910496K082614EVOX ELECTRO DIAGNOSTIC DEVICEGWF2009-03-06
2852541174725416K070331UROSTYM BIOFEEDBACK AND STIMULATION DEVICE AND ACCESSORIESKPI2007-05-04
156201884612647K070331UROSTYM BIOFEEDBACK AND STIMULATION DEVICE AND ACCESSORIESKPI2007-05-04
2852542065803521K062222UNITIP HIGH RESOLUTION CATHETERFFX2007-03-15
2852541730816002K060166OHMEGAFFX2006-04-21
2852541554042888K052338SOLAR GIFFX2005-12-15
2852541095244114K050993MMS VIDEO OPTIONLLZ2005-05-26
2852542040639476K031930HIGH SPEED EMG MODULEGWF2004-03-03
2852541085309848K031084SOLAR GI SYSTEMFFX2004-03-19
156201413264583K013653INCARE PRESSURE BIOFEEDBACK VAGINAL PRESSURE PROBE AND ANAL PRESSURE PROBEHIR2002-03-05
2852541033903290K003580UNITIP GASTROINTESTINAL PRESSURE SENSOR CATHETERFFX2001-07-31
156201493731241
156201517338926
156201642086714
375802037266542
2852541230003448
2852541247260526
2852541573149945
2852541636237745

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
KPI102007-05-04
FFX92024-05-06
FEN41995-07-06
FBK32024-08-27
GWF22009-03-06
HIR22002-03-05
KLA12024-04-23
LLZ12005-05-26

PMN#

NUWAV

2008-07-09

LABORIE MEDICAL TECHNOLOGIES, CORP

UROSTYM

1997-05-20

LABORIE MEDICAL TECHNOLOGIES, LTD.

U-TEX

1996-01-24

LABORIE MEDICAL TECHNOLOGIES, LTD.

DRI SLEEPER

1993-11-24

LABORIE MEDICAL TECHNOLOGIES, LTD.

DRITRAINER

1993-03-03

LABORIE MEDICAL TECHNOLOGIES, LTD.

GUDID#

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