FDA.reportPublic FDA data

Jason Woehrle

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
80320443002806269Jason Woehrle1N2027-01-011601 West River Road N Minneapolis MN US 55411
96106943002806731Jason Woehrle1N2027-01-011601 West River Road N Minneapolis MN US 55411
30038149613003814961Jason Woehrle1N2027-01-011601 West River Road N Minneapolis MN US 55411
30059459073005945907Jason Woehrle1N2027-01-011601 West River Road N Minneapolis MN US 55411
30066069013006606901Jason Woehrle1N2027-01-011601 West River Road N Minneapolis MN US 55411
30113070483011307048Jason Woehrle1N2027-01-011601 West River Road N Minneapolis MN US 55411
30151311443015131144Jason Woehrle1N2027-01-011601 West River Road N Minneapolis MN US 55411
30125217613012521761Jason Woehrle1N2026-01-011601 W River Rd Minneapolis MN US 55411
30155400023015540002Jason Woehrle1N2026-01-011601 W River Rd Minneapolis MN US 55411

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
90751012210062P000006TITAN INFLATABLE PENILE PROSTHESISFHW2000-07-14
90751525424507K991202MODIFICATION TO WOUN'DRESMGQ1999-06-04
90791789041692K973070CONVEEN EASICATH SETEZD1997-11-06
90751789041692K973070CONVEEN EASICATH SETEZD1997-11-06
110261224448296K971244PROVOX 2 VOICE PROSTHESIS SYSTEMEWL1997-06-06
110261511940733K940638PROVOX(TM) VOICE PROSTHESISEWL1994-06-22
2251141450783554K262045Luja SoftEZD2026-07-07
90751450783554K262045Luja SoftEZD2026-07-07
90791493885430K251116Luja CoudéEZD2025-06-27
90751493885430K251116Luja CoudéEZD2025-06-27
90791529422461K250270Luja SetEZD2025-04-17
90751529422461K250270Luja SetEZD2025-04-17
90751866744702K242049SureCath SetEZD2024-11-26
90791866744702K242049SureCath SetEZD2024-11-26
90751196580197K241028Luja female (20051); Luja female (20052); Luja female (20054); Luja female (20056)EZD2024-07-26
90791196580197K241028Luja female (20051); Luja female (20052); Luja female (20054); Luja female (20056)EZD2024-07-26
90751175271200K231953Biatain Fiber Ag (33570 - 5 cm x 5 cm / 2 in x 2 in); Biatain Fiber Ag (33572 - 10 cm x 12 cm / 4 in x 5 in); Biatain Fiber Ag (33574 - 15 cm x 15 cm / 6 in x 6 in); Biatain Fiber Ag (33576 - 2.5 cm x 46 cm / 1 in x 18 in); Biatain Fiber Ag (33578 - 20 cm x 30 cm / 8 in x 12 in)FRO2024-03-22
90751881526356K223821Self-Cath Closed SystemFCM2023-08-02
90751470443785K222059SpeediCath Flex SetEZD2022-09-21
90791470443785K222059SpeediCath Flex SetEZD2022-09-21
90751439648961K221401Self-Cath and Self-Cath PlusEZD2022-12-02
90821439648961K221401Self-Cath and Self-Cath PlusEZD2022-12-02
90791439648961K221401Self-Cath and Self-Cath PlusEZD2022-12-02
90761180206725K211911Kolibri Percutaneous Nephrostomy Catheters, Kolibri Percutaneous Nephrostomy Kits, Kolibri Direct Puncture SetsLJE2022-03-10
90791177768846K210250SpeedCath Compact MaleEZD2022-04-26
90751177768846K210250SpeedCath Compact MaleEZD2022-04-26
2251141177768846K210250SpeedCath Compact MaleEZD2022-04-26
90791210400783K203637SpeediCath Compact (28578, 28580, 28582, 28584), SpeediCath Compact Plus (28810, 28812, 28814)EZD2022-03-08
90751210400783K203637SpeediCath Compact (28578, 28580, 28582, 28584), SpeediCath Compact Plus (28810, 28812, 28814)EZD2022-03-08
90761874553927K201436Vortek Single Loop Ureteral StentFAD2021-02-25
90751500939126K200820SpeediCath Compact SetGBM2020-11-13
90791500939126K200820SpeediCath Compact SetGBM2020-11-13
90791277611293K200142SpeediCath SoftGBM2020-07-30
90751277611293K200142SpeediCath SoftGBM2020-07-30
2251141277611293K200142SpeediCath SoftGBM2020-07-30
90751274597698K192904SpeediCath Compact SetGBM2020-11-02
90791274597698K192904SpeediCath Compact SetGBM2020-11-02
90791232889649K191536Biatain Silicone AgFRO2020-02-21
90751232889649K191536Biatain Silicone AgFRO2020-02-21
90751250002741K190620SpeediCath Flex Coude ProGBM2019-07-10
90791250002741K190620SpeediCath Flex Coude ProGBM2019-07-10
2251141250002741K190620SpeediCath Flex Coude ProGBM2019-07-10
90761982444827K182122Ureteric CathetersEYB2018-10-04
90791857604852K180258SpeediCath StandardGBM2018-10-25
1759491857604852K180258SpeediCath StandardGBM2018-10-25
90751857604852K180258SpeediCath StandardGBM2018-10-25
2251141857604852K180258SpeediCath StandardGBM2018-10-25
90791182507903K180070SpeediCath Flex Coude ProGBM2018-02-02
90761134205747K171043Ureteric Catheters, Flush Ureteric Catheters, Floppy Tip Hydro-Coated Ureteric CathetersEYB2017-12-21
90761163059821K170531Ureteral Dilators and Percutaneous Nephrostomy DilatorsEZN2017-08-17
90791549529009K161672SpeediCath Flex CoudeGBM2016-09-29
90751549529009K161672SpeediCath Flex CoudeGBM2016-09-29
110261443467494K151404ProTrach DualcareJOH2016-02-12
90751399957817K150927Orchestra Hydrophilic Guidewire standard angled, Orchestra Hydrophilic Guidewire straight stiff, Orchestra Hydrophilic Guidewire angled stiff,Orchestra Hydrophilic Guidewire standard straight, Orchestra Hydrophilic Guidewire straight stiffOCY2015-05-27
1759491836703167K143182Speedicath Compact MaleGBM2015-01-20
90751836703167K143182Speedicath Compact MaleGBM2015-01-20
90791836703167K143182Speedicath Compact MaleGBM2015-01-20
110261793078609K141380PROVOX FREEHANDS FLEXIVOICEEWL2014-09-26
90751165732153K140310Peristeen Anal Irrigation SystemKNT2015-09-03
90791165732153K140310Peristeen Anal Irrigation SystemKNT2015-09-03
110261034847053K131947PROVOX VEGA PUNCTURE SETEWL2013-10-18
90752060465545K131072ORCHESTRA HYDROPHILIC GUIDEWIRE STANDARD ANGLED, ORCHESTRA HYDROPHILIC GUIDEWIRE STRAIGHT STIFF, ORCHESTRA HYDROPHILICOCY2013-07-09
90751100181905K121833OSTOMY IRRIGATION SETEXD2012-07-16
90761100181905K121833OSTOMY IRRIGATION SETEXD2012-07-16
90751498251775K121458SPEEDICATH COMPACT SET (12/18 FR)GBM2012-10-01
1759491498251775K121458SPEEDICATH COMPACT SET (12/18 FR)GBM2012-10-01
90791498251775K121458SPEEDICATH COMPACT SET (12/18 FR)GBM2012-10-01
90751780931743K121457SPEEDICATH COMPACT SET (12 FR)GBM2012-10-02
90791780931743K121457SPEEDICATH COMPACT SET (12 FR)GBM2012-10-02
90752009461569K120828BIATAIN SILICONE AG FOAM DRESSING - ADHESIVE: 3X3 INCHES, 4X4 INCHES, & 5X5 INCHESFRO2012-04-05
90791273308554K112860PERISTEEN ANAL IRRIGATION SYSTEM, PERISTEEN ANAL IRRIGATION ACCESSORY UNIT, PERISTEEN ANAL IRRIGATION RECTAL CATHETERKNT2012-06-08
90751273308554K112860PERISTEEN ANAL IRRIGATION SYSTEM, PERISTEEN ANAL IRRIGATION ACCESSORY UNIT, PERISTEEN ANAL IRRIGATION RECTAL CATHETERKNT2012-06-08
90821917523549K100878SELF CATH CATHETEREZD2010-05-26
90751917523549K100878SELF CATH CATHETEREZD2010-05-26
90791917523549K100878SELF CATH CATHETEREZD2010-05-26
90751399213710K100218BIATAIN AGFOAM DRESSINGS-NON-ADHESIV: 5X7CM, 10X10CM, 10X20CM,15X15CM & 20X20CMFRO2010-02-17
90791399213710K100218BIATAIN AGFOAM DRESSINGS-NON-ADHESIV: 5X7CM, 10X10CM, 10X20CM,15X15CM & 20X20CMFRO2010-02-17
110261858402626K092593PROVOX ACTIVALVE (SIZE 4.5MM, 6MM, 8MM, 10MM, 12.5MM)EWL2010-10-14
110261871395635K090455PROVOX VEGA, MODEL 8130-8135EWL2009-06-05
90751020708125K090217BONEE NEEDLE FOR BLADDER INJECTIONS, MODELSNBI035, NBI070FBK2009-04-23
90761020708125K090217BONEE NEEDLE FOR BLADDER INJECTIONS, MODELSNBI035, NBI070FBK2009-04-23
90752041781369K082831AMSELF CLOSED CATHETERIZATION SYSTEMFCM2008-10-23
90751098151627K072808SPEEDICATH COMPACTGBM2007-11-09
90791098151627K072808SPEEDICATH COMPACTGBM2007-11-09
110261167261760K072582PROVOX MICRON HMEJOH2008-05-30
90751804783612K070939SELF-CATH CS CLOSED URINARY CATHETERIZATION SYSTEMFCM2007-06-01
90752021220251K052229COLOPLAST OSTOMY ROD, MODEL 12814EZP2006-10-13
90792021220251K052229COLOPLAST OSTOMY ROD, MODEL 12814EZP2006-10-13
110261831672724K043138PROVOX NID VOICE REHABILITATION SYSTEM, MODEL REF 7101 TO 7134EWL2004-11-22
90751606593199K041316ANTIMICROBIAL ALGINATE DRESSINGFRO2004-08-05
90751923071866K023254SPEEDICATHGBM2003-01-27
90791923071866K023254SPEEDICATHGBM2003-01-27
1759491923071866K023254SPEEDICATHGBM2003-01-27
110262022265825K022125PROVOX FREEHANDS HME, MODEL 7710EWL2002-07-30
110261532947815K014102PROVOX HME CASSETTE, MODEL 7240; PROVOX ADHESIVE, MODEL 7251JOH2002-02-21
90761173916940K013174PROGES FOLYSIL SILICONE FOLEY CATHETER, STRAIGHT CYLINDRICAL TIP, SILICONE FEMALE FOLEY CATHETER, STRAIGHT CYLINDRICAL,EZL2002-01-04
90761119459327K013172PORGES SILICONE PROSTATECTOMY CATHETER, STRAIGHT CYLINDRICAL TIP, DELINOTTE TIP, DUFOUR TIP, OVER THE GUIDE TIP, MODELEZL2001-12-20
90751119459327K013172PORGES SILICONE PROSTATECTOMY CATHETER, STRAIGHT CYLINDRICAL TIP, DELINOTTE TIP, DUFOUR TIP, OVER THE GUIDE TIP, MODELEZL2001-12-20
90821318557118K003784MENTOR SELF-CATH PLUSEZL2001-03-05
110261101603220
90761119879315
90751198410761
90751266369103
90791283319432
90751381517784
90791381517784
90751398980614
1759491398980614
90751414601841
90821414601841
90751787001776
2314752069325390
110261027798751
110261065048837
110261074778555
90751119879315
110261187230716
90751215449625
90761215449625
90821215449625

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
GBM302020-11-13
EZD252026-07-07
EWL82014-09-26
FRO72024-03-22
KNT42015-09-03
EZL42002-01-04
FCM32023-08-02
JOH32016-02-12
EYB22018-10-04
OCY22015-05-27
EXD22012-07-16
FBK22009-04-23
EZP22006-10-13
LJE12022-03-10
FAD12021-02-25
EZN12017-08-17
FHW12000-07-14
MGQ11999-06-04