FDA.reportPublic FDA data

LABORIE MEDICAL TECHNOLOGIES CORP.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30174483603017448360LABORIE MEDICAL TECHNOLOGIES CORP.1Y2026-01-01180 International Drive Portsmouth NH US 03801

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2852541964832235K993721UROSTYM BIOFEEDBACK AND STIMULATION ANAL/RECTAL PROBESKPI1999-11-29
2852541902864480K990041UROSTYM BIOFEEDBACK AND STIMULATION PROBESKPI1999-08-05
2852541862540826K963064ANO-RECTAL MANOMETRY OPTION, MODEL NUMBER UDS-ARMFFX1997-06-05
2852541075557148K962009UROSTYMKPI1997-05-20
2852541282344823K950016CART, MODE NUMBER UDS-CARTFEN1995-03-30
2852541247752666K942023INFUSION 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
2852541240698074K160081TENS ElectrodesGXY2016-10-19
2852541409083868K121014SOLAR GIFFX2012-08-01
2852541639806210K090830LABORIE INJETAK ADJUSTABLE TIP NEEDLE, FLEXIBLE TIP AND RIDGID TIPFBK2009-07-21
2852541174725416K070331UROSTYM 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
2852541033903290K003580UNITIP GASTROINTESTINAL PRESSURE SENSOR CATHETERFFX2001-07-31
2852541230003448
2852541247260526
2852541573149945
2852541636237745
2852541768538603

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
FFX82024-05-06
KPI42007-05-04
FBK22024-08-27
FEN21995-03-30
KLA12024-04-23
GXY12016-10-19
LLZ12005-05-26
GWF12004-03-03

GUDID#