FDA.reportPublic FDA data

LABORIE MEDICAL TECHNOLOGIES, Canada ULC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
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
156201060413213K990456ANAL 2 ELECTRODE STIMULATION/EMG PROBE - W/STOPKPI1999-03-25
156201481381158K990041UROSTYM 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
156201604126123K962009UROSTYMKPI1997-05-20
156201665378448K951805PIPER, MODEL NUMBER UDS-PIPERBFEN1995-07-06
156202034194105K942023INFUSION PUMP, MODEL NO. UDP-5FEN1994-07-12
156201668348481K090830LABORIE INJETAK ADJUSTABLE TIP NEEDLE, FLEXIBLE TIP AND RIDGID TIPFBK2009-07-21
156201801910496K082614EVOX ELECTRO DIAGNOSTIC DEVICEGWF2009-03-06
156201884612647K070331UROSTYM BIOFEEDBACK AND STIMULATION DEVICE AND ACCESSORIESKPI2007-05-04
156201413264583K013653INCARE PRESSURE BIOFEEDBACK VAGINAL PRESSURE PROBE AND ANAL PRESSURE PROBEHIR2002-03-05
156201493731241
156201517338926
156201642086714

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
KPI62007-05-04
HIR22002-03-05
FEN21995-07-06
FBK12009-07-21
GWF12009-03-06
FFX11997-06-05