FDA.reportPublic FDA data

Solventum US LLC

Matched from indexed company URL: SOLVENTUM US LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30317570473031757047Solventum US LLC1N2026-01-01601 22nd Ave S Brookings SD US 57006
30318414333031841433Solventum US LLC1N2026-01-0112930 IH 10 West San Antonio TX US 78249
30321637163032163716Solventum US LLC1N2026-01-012111 McGaw Avenue Irvine CA US 92614
30334692163033469216Solventum US LLC1Y2026-01-01806 W Crystal Lake Rd Forest City IA US 50436
30361088473036108847Solventum US LLC1N2026-01-0110351 West 70th Street Eden Prairie MN US 55344
30364971563036497156Solventum US LLC1N2026-01-015400 Paris Rd Columbia MO US 65202
30365042343036504234Solventum US LLC1N2026-01-01500 Rt. 202 North Flemington NJ US 08822
30422727973042272797SOLVENTUM US LLC1N2026-01-011750 Yankee Doodle Rd Eagan MN US 55121

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00197998001727Solventum™ Kerracel™ - Solventum™ Kerracel™ Gelling Fiber Dressing, CWL1032, 2 in x 2 in (5 cmx 5 cm), 10/CAR, 10 CAR/CS, 100/CS+1(800)228-3957regulatoryrequests@solventum.com
00197998295812Solventum™ Kerracel™ - Solventum™ Kerracel™ Gelling Fiber Dressing, CWL1033, 4 in x 5 in (10 cmx 12.5 cm), 10/CAR, 10 CAR/CS, 100/CS+1(800)228-3957regulatoryrequests@solventum.com
00197998295850Solventum™ Kerracel™ - Solventum™ Kerracel™ Gelling Fiber Dressing, CWL1034, 6 in x 6 in (15 cmx 15 cm), 5/CAR, 10 CAR/CS, 50/CS+1(800)228-3957regulatoryrequests@solventum.com
00197998295898Solventum™ Kerracel™ - Solventum™ Kerracel™ Gelling Fiber Dressing, CWL1035, 1 in x 18 in (2.5cm x 45 cm), 5/CAR, 10 CAR/CS, 50/CS+1(800)228-3957regulatoryrequests@solventum.com
00197998295942Solventum™ Kerracel™ - Solventum™ Kerracel™ Gelling Fiber Dressing, CWL1166, 4 in x 4 in (10 cmx 10 cm), 10/CAR, 10 CAR/CS, 100/CS+1(800)228-3957regulatoryrequests@solventum.com
00197998382819Solventum™ Veraflo™ Cleanse Choice™ - Solventum™ Veraflo™ Cleanse Choice™ Dressing Kit, Medium+1(800)228-3957regulatoryrequests@solventum.com
00197998382895Solventum™ Veraflo™ Cleanse Choice™ - Solventum™ Veraflo™ Cleanse Choice™ Dressing Kit, Large+1(800)228-3957regulatoryrequests@solventum.com
00197998470417Solventum™ Bair Hugger™ - Solventum™ Bair Hugger™ Temperature Monitoring YSI 400 Cable, 90135,Mindray™ Compatible, 5/CS+1(800)228-3957regulatoryrequests@solventum.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3305612028936588K9923263M CLINPRO SEALANTEBC1999-10-08
3314392028936588K9923263M CLINPRO SEALANTEBC1999-10-08
3480402028936588K9923263M CLINPRO SEALANTEBC1999-10-08
3305611661908728K9919613M LVR SYSTEMEBF1999-08-09
3314391661908728K9919613M LVR SYSTEMEBF1999-08-09
3480401661908728K9919613M LVR SYSTEMEBF1999-08-09
3305611411428253K9816473M DENT II SYSTEMEBF1998-08-09
3314391411428253K9816473M DENT II SYSTEMEBF1998-08-09
3480401411428253K9816473M DENT II SYSTEMEBF1998-08-09
3305611028631304K9745533M UNIVERSAL ELECTROSURGICAL PAD, SPLIT (9160) 3M UNIVERSAL ELECTROSURGICAL PAD (9130)GEI1998-02-03
3480401028631304K9745533M UNIVERSAL ELECTROSURGICAL PAD, SPLIT (9160) 3M UNIVERSAL ELECTROSURGICAL PAD (9130)GEI1998-02-03
3305611799470944K9742793M UNIVERSAL ELECTROSURGICAL PAD, WITH CORD (CATALOG NUMBER 9135), 3M UNIVERSAL ELECTROSURGICAL PAD, SPLIT WITH CORD (C)GEI1998-01-30
3480401799470944K9742793M UNIVERSAL ELECTROSURGICAL PAD, WITH CORD (CATALOG NUMBER 9135), 3M UNIVERSAL ELECTROSURGICAL PAD, SPLIT WITH CORD (C)GEI1998-01-30
3305611323474609K9739613M DENT SYSTEM II PLUSEMA1997-12-17
3314391323474609K9739613M DENT SYSTEM II PLUSEMA1997-12-17
3480401323474609K9739613M DENT SYSTEM II PLUSEMA1997-12-17
3305611113851816K973741BAIR HUGGER BLOOD/FLUID WARMERBSB1998-04-30
3371241113851816K973741BAIR HUGGER BLOOD/FLUID WARMERBSB1998-04-30
3480401113851816K973741BAIR HUGGER BLOOD/FLUID WARMERBSB1998-04-30
3314391995115998K9723553M AURORA SYSTEMEBZ1997-08-29
3305611148358400K9637663M PROPLUS SYSTEMELW1996-10-31
3314391148358400K9637663M PROPLUS SYSTEMELW1996-10-31
3480401148358400K9637663M PROPLUS SYSTEMELW1996-10-31
3305611297490653K9627853M DENT SYSTEMKLE1996-08-12
3314391297490653K9627853M DENT SYSTEMKLE1996-08-12
3480401297490653K9627853M DENT SYSTEMKLE1996-08-12
3305611931548215K9620653M VITREBOND LIGHT CURE GLASS IONOMER/BASEEMA1996-07-18
3314391931548215K9620653M VITREBOND LIGHT CURE GLASS IONOMER/BASEEMA1996-07-18
3480401931548215K9620653M VITREBOND LIGHT CURE GLASS IONOMER/BASEEMA1996-07-18
3303641651411152K9551033M NO STING BARRIER FILMKMF1996-02-05
3305611651411152K9551033M NO STING BARRIER FILMKMF1996-02-05
3371211651411152K9551033M NO STING BARRIER FILMKMF1996-02-05
3480401651411152K9551033M NO STING BARRIER FILMKMF1996-02-05
3305611967179465K952408ATI DISPOSABLE TEST PACK FOR STEAM STERILIZATIONJOJ1995-07-06
3371231967179465K952408ATI DISPOSABLE TEST PACK FOR STEAM STERILIZATIONJOJ1995-07-06
3480401967179465K952408ATI DISPOSABLE TEST PACK FOR STEAM STERILIZATIONJOJ1995-07-06
3305612003078849K941189DISPOSABLE PROPHYLAXIS ANGLEEGS1994-05-16
3480402003078849K941189DISPOSABLE PROPHYLAXIS ANGLEEGS1994-05-16
3305611584597090K935267B-D DIGITAL THERMOMETERFLL1994-08-17
3480401584597090K935267B-D DIGITAL THERMOMETERFLL1994-08-17
3305611165664633K9331393M VITREMER LUTING CEMENTEMA1994-01-05
3314391165664633K9331393M VITREMER LUTING CEMENTEMA1994-01-05
3480401165664633K9331393M VITREMER LUTING CEMENTEMA1994-01-05
3305611653877323K925496ATI DISPOSABLE BIOLOGICAL-PLUS TEST PACKFRC1994-02-01
3371231653877323K925496ATI DISPOSABLE BIOLOGICAL-PLUS TEST PACKFRC1994-02-01
3480401653877323K925496ATI DISPOSABLE BIOLOGICAL-PLUS TEST PACKFRC1994-02-01
3305611237845538K9250323M VITREMER TRI-CURE GLASS IONOMER SYSTEMEMA1992-12-23
3314391237845538K9250323M VITREMER TRI-CURE GLASS IONOMER SYSTEMEMA1992-12-23
3480401237845538K9250323M VITREMER TRI-CURE GLASS IONOMER SYSTEMEMA1992-12-23
3314391796351787K9248123M CURING LIGHT XL 3000EBZ1992-11-25
3305611924400195K9204253M BRAND RESTORATIVE Z100EBF1992-03-20
3314391924400195K9204253M BRAND RESTORATIVE Z100EBF1992-03-20
3480401924400195K9204253M BRAND RESTORATIVE Z100EBF1992-03-20
3305611050452124K920424SCOTCHBOND BRAND MULTI-PURPOSE ADHESIVE SYSTEMKLE1992-03-20
3314391050452124K920424SCOTCHBOND BRAND MULTI-PURPOSE ADHESIVE SYSTEMKLE1992-03-20
3480401050452124K920424SCOTCHBOND BRAND MULTI-PURPOSE ADHESIVE SYSTEMKLE1992-03-20
3305611680458036K911271ADHESIVE PRECOATED BRACKETSDYH1991-05-29
3314391680458036K911271ADHESIVE PRECOATED BRACKETSDYH1991-05-29
3305611981649698K904921STERI-VAC(TM) AERATOR MODEL XLFLI1990-12-05
3480401981649698K904921STERI-VAC(TM) AERATOR MODEL XLFLI1990-12-05
3303641582952729K900771ATTEST BRAND RAPID READOUT BIOLOGICAL INDICATORFRC1990-07-03
3305611582952729K900771ATTEST BRAND RAPID READOUT BIOLOGICAL INDICATORFRC1990-07-03
3480401582952729K900771ATTEST BRAND RAPID READOUT BIOLOGICAL INDICATORFRC1990-07-03
3305611960399990K900332EM 1149 OPTIMIZE SCOTCHPLATE CONDUC ADHES DISP ELEGEI1990-02-13
3480401960399990K900332EM 1149 OPTIMIZE SCOTCHPLATE CONDUC ADHES DISP ELEGEI1990-02-13
3305612060291084K882690IMPRINT VINYL POLYSILOXANE IMPRESSION MATERIALELW1988-08-11
3314392060291084K882690IMPRINT VINYL POLYSILOXANE IMPRESSION MATERIALELW1988-08-11
3480402060291084K882690IMPRINT VINYL POLYSILOXANE IMPRESSION MATERIALELW1988-08-11
3305611784832609K853698SCOTCHPRIME CERAMIC PRIMEREIH1985-11-14
3314391784832609K853698SCOTCHPRIME CERAMIC PRIMEREIH1985-11-14
3480401784832609K853698SCOTCHPRIME CERAMIC PRIMEREIH1985-11-14
3305611621640647K852192DISPOSABLE STEAM BIOLOGICAL TEST PACKFRC1985-11-01
3371231621640647K852192DISPOSABLE STEAM BIOLOGICAL TEST PACKFRC1985-11-01
3480401621640647K852192DISPOSABLE STEAM BIOLOGICAL TEST PACKFRC1985-11-01
3305611591810838K844211CONCISE LIGHT CURED WHITE SEALANTEBC1985-01-07
3314391591810838K844211CONCISE LIGHT CURED WHITE SEALANTEBC1985-01-07
3480401591810838K844211CONCISE LIGHT CURED WHITE SEALANTEBC1985-01-07
3305611313924285K8333643M SCOTCHPLATE II DISPERSIVE ELECTRODEGEI1983-11-29
3480401313924285K8333643M SCOTCHPLATE II DISPERSIVE ELECTRODEGEI1983-11-29
3305611920174996K8236893M SCOTCHPLATE 51148 SMALL CONDUCTIVEGEI1983-01-12
3480401920174996K8236893M SCOTCHPLATE 51148 SMALL CONDUCTIVEGEI1983-01-12
3305611053561607K813202THERMALOG S STEAM STERILIZATION INTEGRAJOJ1981-12-31
3371231053561607K813202THERMALOG S STEAM STERILIZATION INTEGRAJOJ1981-12-31
3480401053561607K813202THERMALOG S STEAM STERILIZATION INTEGRAJOJ1981-12-31
3305611860426448K813180SCOTCHBOND DENTAL ADHESIVEKLE1982-01-12
3314391860426448K813180SCOTCHBOND DENTAL ADHESIVEKLE1982-01-12
3480401860426448K813180SCOTCHBOND DENTAL ADHESIVEKLE1982-01-12
3314391841580344K810266ETCHING GELEJK1981-02-23
3303641884034085K8015503M GERMICIDAL SURGICAL INCISE DRAPEKKX1981-09-17
3305611884034085K8015503M GERMICIDAL SURGICAL INCISE DRAPEKKX1981-09-17
3480401884034085K8015503M GERMICIDAL SURGICAL INCISE DRAPEKKX1981-09-17
3305612051363190K800485VINYL POLYSILOXANE IMPRESSION MATERIALELW1980-03-18
3314392051363190K800485VINYL POLYSILOXANE IMPRESSION MATERIALELW1980-03-18
3480402051363190K800485VINYL POLYSILOXANE IMPRESSION MATERIALELW1980-03-18
3305611405520774K771080STEAM STERILIZATION INDICATORFRC1977-07-14
3371231405520774K771080STEAM STERILIZATION INDICATORFRC1977-07-14
3480401405520774K771080STEAM STERILIZATION INDICATORFRC1977-07-14
3303641178165596K2425383M™ Attest™ Super Rapid Readout Biological Indicator 1493; 3M™ Attest™ Super Rapid Steam Gravity Clear Challenge Pack 1493PCDG; 3M™ Attest™ Auto-reader 490; 3M™ Attest™ Auto-reader 490H; 3M™ Attest™ Mini Auto-reader 490MFRC2024-11-25
3305611178165596K2425383M™ Attest™ Super Rapid Readout Biological Indicator 1493; 3M™ Attest™ Super Rapid Steam Gravity Clear Challenge Pack 1493PCDG; 3M™ Attest™ Auto-reader 490; 3M™ Attest™ Auto-reader 490H; 3M™ Attest™ Mini Auto-reader 490MFRC2024-11-25
3480401178165596K2425383M™ Attest™ Super Rapid Readout Biological Indicator 1493; 3M™ Attest™ Super Rapid Steam Gravity Clear Challenge Pack 1493PCDG; 3M™ Attest™ Auto-reader 490; 3M™ Attest™ Auto-reader 490H; 3M™ Attest™ Mini Auto-reader 490MFRC2024-11-25
3303641000371818K2419593M™ Attest™ Super Rapid Steam Clear Challenge Pack (1492PCD); 3M™ Attest™ Auto-reader (490); 3M™ Attest™ Auto-reader (490H); 3M™ Attest™ Mini Auto-reader (490M)FRC2024-10-18
3305611000371818K2419593M™ Attest™ Super Rapid Steam Clear Challenge Pack (1492PCD); 3M™ Attest™ Auto-reader (490); 3M™ Attest™ Auto-reader (490H); 3M™ Attest™ Mini Auto-reader (490M)FRC2024-10-18
3480401000371818K2419593M™ Attest™ Super Rapid Steam Clear Challenge Pack (1492PCD); 3M™ Attest™ Auto-reader (490); 3M™ Attest™ Auto-reader (490H); 3M™ Attest™ Mini Auto-reader (490M)FRC2024-10-18
3303641943226684K2417103M™ Attest™ Super Rapid Readout Biological Indicator 1492V; 3M™ Attest™ Auto-reader 490; 3M™ Attest™ Auto-reader 490H; 3M™ Attest™ Mini Auto-reader 490MFRC2024-09-12
3305611943226684K2417103M™ Attest™ Super Rapid Readout Biological Indicator 1492V; 3M™ Attest™ Auto-reader 490; 3M™ Attest™ Auto-reader 490H; 3M™ Attest™ Mini Auto-reader 490MFRC2024-09-12
3480401943226684K2417103M™ Attest™ Super Rapid Readout Biological Indicator 1492V; 3M™ Attest™ Auto-reader 490; 3M™ Attest™ Auto-reader 490H; 3M™ Attest™ Mini Auto-reader 490MFRC2024-09-12
3303641078964425K2415423M™ Attest™ Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack 1295PCD (1295PCD)FRC2024-06-27
3305611078964425K2415423M™ Attest™ Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack 1295PCD (1295PCD)FRC2024-06-27
3480401078964425K2415423M™ Attest™ Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack 1295PCD (1295PCD)FRC2024-06-27
3314391487308510K2340433M™ Transbond™ Orthodontic AdhesiveDYH2023-12-22
3480401706256414K2340433M™ Transbond™ Orthodontic AdhesiveDYH2023-12-22
3305611833058374K2313383M™ Clinpro™ Clear 2.1% Sodium Fluoride TreatmentLBH2023-05-10
3314391833058374K2313383M™ Clinpro™ Clear 2.1% Sodium Fluoride TreatmentLBH2023-05-10
3480401833058374K2313383M™ Clinpro™ Clear 2.1% Sodium Fluoride TreatmentLBH2023-05-10
3305611114084509K2302703M™ VitCal Liner/BaseEJK2023-02-06
3314391114084509K2302703M™ VitCal Liner/BaseEJK2023-02-06
3480401114084509K2302703M™ VitCal Liner/BaseEJK2023-02-06
3303641159141559K2225783M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG)KKX2023-05-18
3305611159141559K2225783M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG)KKX2023-05-18
3480401159141559K2225783M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG)KKX2023-05-18

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
FRC552024-11-25
EBF362022-06-13
EMA302011-05-05
JOJ292024-05-21
QBP162020-10-29
FRO102020-09-04
GEI101998-02-03
KMF92016-08-23
ELW91996-10-31
KLE91996-08-12
LBH82023-05-10
DWJ72021-04-29
KKX62023-05-18
EBC61999-10-08
FLL52012-05-30
DYH42023-12-22
EJK42023-02-06
FXX42019-09-11
QKM32022-04-20
SEL32017-07-11
LGZ32006-06-26
BSB31998-04-30
EIH31985-11-14
FLF22015-01-08
DRG22012-05-03
DQD22005-02-22
DZE22004-09-15
EBZ21997-08-29
EGS21994-05-16
FLI21990-12-05

NDC#

GUDID#

200 records. Showing 1-40. Next