FDA.report

Jason Woehrle

FDA Registration(s)

RegistrationFEINameStatusInitial importerExpiration yearAddress
96106943002806731Jason Woehrle1N2026-01-011601 West River Road N Minneapolis MN US 55411
30038149613003814961Jason Woehrle1N2026-01-011601 West River Road N Minneapolis MN US 55411
30059459073005945907Jason Woehrle1N2026-01-011601 West River Road N Minneapolis MN US 55411
30062673333006267333Jason Woehrle1N2026-01-011601 West River Road N Minneapolis MN US 55411
30066069013006606901Jason Woehrle1N2026-01-011601 West River Road N Minneapolis MN US 55411
30082622783008262278Jason Woehrle1N2026-01-011601 West River Road N Minneapolis MN US 55411
30125217613012521761Jason Woehrle1N2026-01-011601 W River Rd Minneapolis MN US 55411
30151311443015131144Jason Woehrle1N2026-01-011601 West River Road N Minneapolis MN US 55411
30155400023015540002Jason Woehrle1N2026-01-011601 W River Rd Minneapolis MN US 55411

Registered Device Listings

Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
90751012210062P000006TITAN INFLATABLE PENILE PROSTHESISFHW2000-07-14
90751525424507K991202MODIFICATION TO WOUN'DRESMGQ1999-06-04
90751789041692K973070CONVEEN EASICATH SETEZD1997-11-06
90791789041692K973070CONVEEN EASICATH SETEZD1997-11-06
1145701789041692K973070CONVEEN EASICATH SETEZD1997-11-06
90751493885430K251116Luja CoudéEZD2025-06-27
90791493885430K251116Luja CoudéEZD2025-06-27
90751529422461K250270Luja SetEZD2025-04-17
90791529422461K250270Luja 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
90791439648961K221401Self-Cath and Self-Cath PlusEZD2022-12-02
90821439648961K221401Self-Cath and Self-Cath PlusEZD2022-12-02
90761180206725K211911Kolibri Percutaneous Nephrostomy Catheters, Kolibri Percutaneous Nephrostomy Kits, Kolibri Direct Puncture SetsLJE2022-03-10
90751177768846K210250SpeedCath Compact MaleEZD2022-04-26
90791177768846K210250SpeedCath Compact MaleEZD2022-04-26
2251141177768846K210250SpeedCath Compact MaleEZD2022-04-26
90751210400783K203637SpeediCath Compact (28578, 28580, 28582, 28584), SpeediCath Compact Plus (28810, 28812, 28814)EZD2022-03-08
90791210400783K203637SpeediCath Compact (28578, 28580, 28582, 28584), SpeediCath Compact Plus (28810, 28812, 28814)EZD2022-03-08
1145701210400783K203637SpeediCath 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
90751277611293K200142SpeediCath SoftGBM2020-07-30
90791277611293K200142SpeediCath SoftGBM2020-07-30
2251141277611293K200142SpeediCath SoftGBM2020-07-30
90751274597698K192904SpeediCath Compact SetGBM2020-11-02
90791274597698K192904SpeediCath Compact SetGBM2020-11-02
90751232889649K191536Biatain Silicone AgFRO2020-02-21
90791232889649K191536Biatain Silicone AgFRO2020-02-21
1145701232889649K191536Biatain 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
90751857604852K180258SpeediCath StandardGBM2018-10-25
90791857604852K180258SpeediCath StandardGBM2018-10-25
1145701857604852K180258SpeediCath 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
90751549529009K161672SpeediCath Flex CoudeGBM2016-09-29
90791549529009K161672SpeediCath Flex CoudeGBM2016-09-29
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
90751836703167K143182Speedicath Compact MaleGBM2015-01-20
90791836703167K143182Speedicath Compact MaleGBM2015-01-20
90751165732153K140310Peristeen Anal Irrigation SystemKNT2015-09-03
90791165732153K140310Peristeen Anal Irrigation SystemKNT2015-09-03
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
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
1145702009461569K120828BIATAIN SILICONE AG FOAM DRESSING - ADHESIVE: 3X3 INCHES, 4X4 INCHES, & 5X5 INCHESFRO2012-04-05
90751273308554K112860PERISTEEN ANAL IRRIGATION SYSTEM, PERISTEEN ANAL IRRIGATION ACCESSORY UNIT, PERISTEEN ANAL IRRIGATION RECTAL CATHETERKNT2012-06-08
90791273308554K112860PERISTEEN ANAL IRRIGATION SYSTEM, PERISTEEN ANAL IRRIGATION ACCESSORY UNIT, PERISTEEN ANAL IRRIGATION RECTAL CATHETERKNT2012-06-08
90751917523549K100878SELF CATH CATHETEREZD2010-05-26
90791917523549K100878SELF CATH CATHETEREZD2010-05-26
90821917523549K100878SELF 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
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
1145701098151627K072808SPEEDICATH COMPACTGBM2007-11-09
90751804783612K070939SELF-CATH CS CLOSED URINARY CATHETERIZATION SYSTEMFCM2007-06-01
90752021220251K052229COLOPLAST OSTOMY ROD, MODEL 12814EZP2006-10-13
90792021220251K052229COLOPLAST OSTOMY ROD, MODEL 12814EZP2006-10-13
1145702021220251K052229COLOPLAST OSTOMY ROD, MODEL 12814EZP2006-10-13
90751606593199K041316ANTIMICROBIAL ALGINATE DRESSINGFRO2004-08-05
1145701606593199K041316ANTIMICROBIAL ALGINATE DRESSINGFRO2004-08-05
90751923071866K023254SPEEDICATHGBM2003-01-27
90791923071866K023254SPEEDICATHGBM2003-01-27
1145701923071866K023254SPEEDICATHGBM2003-01-27
90761173916940K013174PROGES FOLYSIL SILICONE FOLEY CATHETER, STRAIGHT CYLINDRICAL TIP, SILICONE FEMALE FOLEY CATHETER, STRAIGHT CYLINDRICAL,EZL2002-01-04
90751119459327K013172PORGES SILICONE PROSTATECTOMY CATHETER, STRAIGHT CYLINDRICAL TIP, DELINOTTE TIP, DUFOUR TIP, OVER THE GUIDE TIP, MODELEZL2001-12-20
90761119459327K013172PORGES SILICONE PROSTATECTOMY CATHETER, STRAIGHT CYLINDRICAL TIP, DELINOTTE TIP, DUFOUR TIP, OVER THE GUIDE TIP, MODELEZL2001-12-20
90821318557118K003784MENTOR SELF-CATH PLUSEZL2001-03-05
90761119879315
90751198410761
90751266369103
1145701274346639
90791283319432
1145701283319432
90751381517784
90791381517784
1145701381517784
90751398980614
90751414601841
90821414601841
90751787001776
1145701787001776
2314752069325390
90751119879315
1145701119879315
90751215449625
90761215449625
90821215449625
1145701215449625
90751221578967
90761221578967
1145701221578967
90761266369103
90751274346639
90751283319432
90761283319432

Product Codes Associated With Registrations

Product codeRegistration listing recordsLatest decision
GBM292020-11-13
EZD252025-06-27
FRO102024-03-22
KNT42015-09-03
EZL42002-01-04
FCM32023-08-02
EZP32006-10-13
EYB22018-10-04
OCY22015-05-27
EXD22012-07-16
FBK22009-04-23
LJE12022-03-10
FAD12021-02-25
EZN12017-08-17
FHW12000-07-14
MGQ11999-06-04