FDA.reportPublic FDA data

Carson Harvey

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30383569003038356900Carson Harvey1N2026-01-01311 S Wacker Dr Ste 4100 Chicago IL US 60606
30440260043044026004Carson Harvey1N2026-01-01311 S Wacker Dr Ste 4100 Chicago IL US 60606

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3482051235786487K990519PHOENIX EPIDURAL & SPINAL NEEDLESBSP2000-06-02
3495091235786487K990519PHOENIX EPIDURAL & SPINAL NEEDLESBSP2000-06-02
3482051188202406K861153DISPOSABLE SYRINGES AND HYPODERMIC NEEDLESFMF1986-04-23
3495091188202406K861153DISPOSABLE SYRINGES AND HYPODERMIC NEEDLESFMF1986-04-23
3482051057196136K842115SPUNGARD & SURG. DRAPES-GOWNS & PACKSKKX1984-06-11
3495091057196136K842115SPUNGARD & SURG. DRAPES-GOWNS & PACKSKKX1984-06-11
3482051041499258K250907Sol-Guard TM XtraThin Safety Pull-Button Blood Collection SetJKA2025-04-30
3495091041499258K250907Sol-Guard TM XtraThin Safety Pull-Button Blood Collection SetJKA2025-04-30
3482051703493066K242291SOL-M Luer Lock Syringe (Low Dead Space) w/o Needle, SOL-M Slip Tip Syringe (Low Dead Space) w/o needle, SOL-M Luer Lock Syringe (Low Dead Space) w/Exchangeable Needle, SOL-CARE Luer Lock Syringe (Low Dead Space) w/Safety Needle, SOL-M Slip Tip Syringe (Low Dead Space) w/Exchangeable NeedleQNQ2024-11-20
3495091703493066K242291SOL-M Luer Lock Syringe (Low Dead Space) w/o Needle, SOL-M Slip Tip Syringe (Low Dead Space) w/o needle, SOL-M Luer Lock Syringe (Low Dead Space) w/Exchangeable Needle, SOL-CARE Luer Lock Syringe (Low Dead Space) w/Safety Needle, SOL-M Slip Tip Syringe (Low Dead Space) w/Exchangeable NeedleQNQ2024-11-20
3482051641048381K242099Sol-M™ Slip Tip Syringe without Needle, Sol-M™ Eccentric Tip Syringe without NeedleFMF2024-10-22
3495091641048381K242099Sol-M™ Slip Tip Syringe without Needle, Sol-M™ Eccentric Tip Syringe without NeedleFMF2024-10-22
3482051380690087K241821Luer Lock Syringe with Safety Needle; Luer Lock Syringe with Exchangeable Needle; Luer Lock Syringe with Blunt Fill NeedleFMF2024-09-20
3495091380690087K241821Luer Lock Syringe with Safety Needle; Luer Lock Syringe with Exchangeable Needle; Luer Lock Syringe with Blunt Fill NeedleFMF2024-09-20
3482051493448393K231792VeriSafe Safety sterile syringesFMF2023-09-28
3495091493448393K231792VeriSafe Safety sterile syringesFMF2023-09-28
3482051849761462K231564Skin and Wound CleanserFRO2023-11-10
3495091849761462K231564Skin and Wound CleanserFRO2023-11-10
3482051940088049K231057Antibacterial Gel Wound DressingFRO2023-12-01
3495091940088049K231057Antibacterial Gel Wound DressingFRO2023-12-01
3482051899610783K230715Promisemed Safety Huber NeedlePTI2023-06-08
3495091899610783K230715Promisemed Safety Huber NeedlePTI2023-06-08
3482051277897255K223643Verifine® Ease Lancing Device, Verifine® Lancing DeviceQRL2023-02-21
3495091277897255K223643Verifine® Ease Lancing Device, Verifine® Lancing DeviceQRL2023-02-21
3482051638160453K223453Insulin SyringeFMF2023-03-02
3495091638160453K223453Insulin SyringeFMF2023-03-02
3482052064434754K222744Sol-M Luer Lock SyringeFMF2022-10-11
3495092064434754K222744Sol-M Luer Lock SyringeFMF2022-10-11
3482052064004971K222271Verisafe Safety sterile needlesFMI2023-02-15
3495092064004971K222271Verisafe Safety sterile needlesFMI2023-02-15
3482051420165919K221754Ag Foam Dressing Non-Adhesive (OTC); Ag Foam Dressing Adhesive (OTC); Silicone Ag Foam Dressing (OTC); Silicone Ag Foam Dressing with Border (OTC)FRO2023-01-17
3495091420165919K221754Ag Foam Dressing Non-Adhesive (OTC); Ag Foam Dressing Adhesive (OTC); Silicone Ag Foam Dressing (OTC); Silicone Ag Foam Dressing with Border (OTC)FRO2023-01-17
3482051434722537K221371Promisemed Heel Blood LancetFMK2022-06-08
3495091434722537K221371Promisemed Heel Blood LancetFMK2022-06-08
3482051617255408K221368Promisemed Blood Lancet, VeriFine Safety Lancet, VeriFine Mini-Safety LancetFMK2022-06-09
3495091617255408K221368Promisemed Blood Lancet, VeriFine Safety Lancet, VeriFine Mini-Safety LancetFMK2022-06-09
3482051005535814K220713Sol-Guard Auto-disable SyringeFMF2023-05-04
3495091005535814K220713Sol-Guard Auto-disable SyringeFMF2023-05-04
3482051806066336K220194Procedure mask/Surgical mask/Face maskFXX2022-05-17
3495091806066336K220194Procedure mask/Surgical mask/Face maskFXX2022-05-17
3482051898722872K220129Promisemed X-Safety Pen NeedleFMI2022-09-19
3495091898722872K220129Promisemed X-Safety Pen NeedleFMI2022-09-19
3482051204328644K213718SOL-GUARD Safety Pull Button Collection SetJKA2022-08-30
3495091204328644K213718SOL-GUARD Safety Pull Button Collection SetJKA2022-08-30
3482051556528956K213683Promisemed Fine Biopsy NeedleKNW2022-04-22
3495091556528956K213683Promisemed Fine Biopsy NeedleKNW2022-04-22
3482051375209856K213560Verifine Safety Syringe with Fixed NeedleFMF2022-04-05
3495091375209856K213560Verifine Safety Syringe with Fixed NeedleFMF2022-04-05
3482051393278364K212120Surgical MasksFXX2022-01-28
3495091393278364K212120Surgical MasksFXX2022-01-28
3482051494579183K211890Promisemed Sharps containerMMK2021-11-17
3495091494579183K211890Promisemed Sharps containerMMK2021-11-17
3482051620532507K211293Safety Winged Blood Collection SetsFMI2021-06-25
3495091620532507K211293Safety Winged Blood Collection SetsFMI2021-06-25
3482051095839920K211242Promisemed Sterile Hypodermic Syringes, Verifine Sterile Hypodermic SyringesFMF2021-09-09
3495091095839920K211242Promisemed Sterile Hypodermic Syringes, Verifine Sterile Hypodermic SyringesFMF2021-09-09
3482051032996743K210946Promisemed Automatic Biopsy Needles, Promisemed Co-Axial Biopsy Devices, Promisemed Semi-automatic Biopsy NeedlesKNW2021-08-12
3495091032996743K210946Promisemed Automatic Biopsy Needles, Promisemed Co-Axial Biopsy Devices, Promisemed Semi-automatic Biopsy NeedlesKNW2021-08-12
3482051331683462K210712Verifine Mechanical Safety Insulin SyringeFMF2021-09-08
3495091331683462K210712Verifine Mechanical Safety Insulin SyringeFMF2021-09-08
3482051120490360K210065Verifine Safety Type Insulin Pen NeedleFMI2021-04-22
3495091120490360K210065Verifine Safety Type Insulin Pen NeedleFMI2021-04-22
3482051846606122K210059Promisemed Insulin Pen NeedleFMI2021-07-21
3495091846606122K210059Promisemed Insulin Pen NeedleFMI2021-07-21
3482051894483514K202982Silver Alginate Dressing (Prescription use), Antibacterial Alginate Would Dressing (OTC use)FRO2021-10-19
3495091894483514K202982Silver Alginate Dressing (Prescription use), Antibacterial Alginate Would Dressing (OTC use)FRO2021-10-19
3482051814506423K202732SOL-CARE IV Bag Safety ConnectorLHI2021-11-03
3495091814506423K202732SOL-CARE IV Bag Safety ConnectorLHI2021-11-03
3482051364769001K202682Promisemed Triple Safety Pen NeedleFMI2020-11-24
3495091364769001K202682Promisemed Triple Safety Pen NeedleFMI2020-11-24
3482051953315199K202681Promisemed Covered Safety Pen NeedleFMI2020-12-31
3495091953315199K202681Promisemed Covered Safety Pen NeedleFMI2020-12-31
3482051035424838K201530Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Fusion Dark Grey)LZA2020-08-05
3495091035424838K201530Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Fusion Dark Grey)LZA2020-08-05
3482051268687672K193273Insulin SyringeFMF2021-01-05
3495091268687672K193273Insulin SyringeFMF2021-01-05
3482051376610342K193009Promisemed Heel Blood LancetFMK2019-12-03
3495091376610342K193009Promisemed Heel Blood LancetFMK2019-12-03
3482051644825836K192666Promisemed Blood Lancet, VeriFine Safety Lancet, VeriFine Mini-Safety LancetFMK2019-12-02
3495091644825836K192666Promisemed Blood Lancet, VeriFine Safety Lancet, VeriFine Mini-Safety LancetFMK2019-12-02
3482051220132942K191853Dual-Safety Pen NeedleFMI2019-09-05
3495091220132942K191853Dual-Safety Pen NeedleFMI2019-09-05
3482051923667428K182830Cardinal HealthTM Poly-Coated Open-Back Protective GownQPC2019-04-26
3495091923667428K182830Cardinal HealthTM Poly-Coated Open-Back Protective GownQPC2019-04-26
3482051847505971K182146Sol-M Blood Collection Needles, Sol-Care Safety Blood Collection Needles, Sol-Care Safety Blood Collection Needle with Holders, Sol-M Blood Collection SetFMI2018-12-03
3495091847505971K182146Sol-M Blood Collection Needles, Sol-Care Safety Blood Collection Needles, Sol-Care Safety Blood Collection Needle with Holders, Sol-M Blood Collection SetFMI2018-12-03
3482051728335925K173509Biodegradable Nitrile Powder Free Examination Glove (Blue)LZA2018-08-17
3495091728335925K173509Biodegradable Nitrile Powder Free Examination Glove (Blue)LZA2018-08-17
3482051632247094K163073Sol-Care Safety Blood Collection Needle with and without Pre-Attached HolderJKA2017-05-19
3495091632247094K163073Sol-Care Safety Blood Collection Needle with and without Pre-Attached HolderJKA2017-05-19
3482051920017986K161950Common Type Insulin Pen Needle, Safety Type Insulin Pen NeedleFMI2017-05-11
3495091920017986K161950Common Type Insulin Pen Needle, Safety Type Insulin Pen NeedleFMI2017-05-11
3482051638697900K160199Advocate Insulin Pen NeedlesFMI2016-10-19
3495091638697900K160199Advocate Insulin Pen NeedlesFMI2016-10-19
3482051606635054K153537Sol-M Insulin Syringe, Sol-M TB SyringeFMF2016-06-17
3495091606635054K153537Sol-M Insulin Syringe, Sol-M TB SyringeFMF2016-06-17
3482051812311524K151836NITRILE POWDER FREE EXAMINATION GLOVES-PINK, NITRILE POWDER FREE EXAMINATION GLOVES-GREEN,NITRILE POWDER FREE EXAMINATION GLOVES-ORANGE, NITRILE POWDER FREE EXAMINATION GLOVES-BLACKLZA2015-10-21
3495091812311524K151836NITRILE POWDER FREE EXAMINATION GLOVES-PINK, NITRILE POWDER FREE EXAMINATION GLOVES-GREEN,NITRILE POWDER FREE EXAMINATION GLOVES-ORANGE, NITRILE POWDER FREE EXAMINATION GLOVES-BLACKLZA2015-10-21
3482051869656687K140610NITRILE POWDER FREE EXAMINATION GLOVE - AQUA BLUE (ABLU) / VIOLET BLUE (VBLU) / DARK BLUE (DKBU)LZA2014-06-20
3495091869656687K140610NITRILE POWDER FREE EXAMINATION GLOVE - AQUA BLUE (ABLU) / VIOLET BLUE (VBLU) / DARK BLUE (DKBU)LZA2014-06-20
3482051336944142K132681SOL-GUARD INSULIN AND TUBERCULIN SAFETY SYRINGEMEG2014-05-22
3495091336944142K132681SOL-GUARD INSULIN AND TUBERCULIN SAFETY SYRINGEMEG2014-05-22
3482051217209723K123684SOL-CARE SAFETY NEEDLEFMI2013-05-08
3495091217209723K123684SOL-CARE SAFETY NEEDLEFMI2013-05-08
3482051335403672K112777SOL-M EXCHANGEABLE NEEDLESFMI2012-02-24
3495091335403672K112777SOL-M EXCHANGEABLE NEEDLESFMI2012-02-24
3482051600527130K112057KDL SYRINGES AND NEEDLEFMF2011-12-14
3495091600527130K112057KDL SYRINGES AND NEEDLEFMF2011-12-14
3482051774847025K101359INVIROSTRIPE LUER LOCK SYRINGES (1, 3, 10, 20, 30 AND 60 ML)FMF2010-08-20
3495091774847025K101359INVIROSTRIPE LUER LOCK SYRINGES (1, 3, 10, 20, 30 AND 60 ML)FMF2010-08-20
3482051569988903K093115KIMBERLY-CLARK KC100 SURGICAL GOWN, MODEL KC100FYA2010-03-19
3495091569988903K093115KIMBERLY-CLARK KC100 SURGICAL GOWN, MODEL KC100FYA2010-03-19
3482051899493003K0924301 ML FIXED NEEDLE, 3 ML LUER LOCK, 5 ML LUER LOCK, 10 ML LUER LOCK, 20 ML LUERL LOCK SAFETY SYRINGESMEG2009-09-04
3495091899493003K0924301 ML FIXED NEEDLE, 3 ML LUER LOCK, 5 ML LUER LOCK, 10 ML LUER LOCK, 20 ML LUERL LOCK SAFETY SYRINGESMEG2009-09-04
3482051356066522K092413INVIROSNAP 50 AND 100 UNIT INSULIN SAFETY SYRINGESMEG2009-09-04
3495091356066522K092413INVIROSNAP 50 AND 100 UNIT INSULIN SAFETY SYRINGESMEG2009-09-04
3482051326272911K092172EXEL I.V. EXTENSION SETFPA2010-01-04
3495091326272911K092172EXEL I.V. EXTENSION SETFPA2010-01-04
3482051486520867K083851INVIROBLUNT CANNULA WITH AND WITHOUT EZ WINGS, MODELS 120522 AND 120022LHI2009-05-15
3495091486520867K083851INVIROBLUNT CANNULA WITH AND WITHOUT EZ WINGS, MODELS 120522 AND 120022LHI2009-05-15

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
FMF302024-10-22
FMI282023-02-15
FRO82023-12-01
FMK82022-06-09
LZA82020-08-05
JKA62025-04-30
MEG62014-05-22
FPA62010-01-04
FXX42022-05-17
KNW42022-04-22
LHI42021-11-03
QNQ22024-11-20
PTI22023-06-08
QRL22023-02-21
MMK22021-11-17
QPC22019-04-26
FYA22010-03-19
MSH22006-12-08
BSP22000-06-02
KKX21984-06-11