FDA.reportPublic FDA data

MEDLINE INDUSTRIES, LP - Northfield

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
14175921417592MEDLINE INDUSTRIES, LP - Northfield1Y2026-01-01Three Lakes Drive Northfield IL US 60093

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
23391687024716K994352SIDE DRAFT NEB-U-MIST NEBULIZER, MODEL 41896CAF2000-03-22
23391533318543K993355HUDSON RCI CONCHA COLUMN, CAT. NO. 385-40 AND HUDSON RCI CIRCUIT, CAT. NO. 780-40, 780-41, 780-42, 780-43BTT2000-05-24
23391621770857K993317ACON HCG ONE STEP PREGNANCY TEST DEVICE (URINE)JHI1999-12-01
23391030865642K993203ACON ONE STEP PREGNANCY TEST STRIP (URINE)JHI1999-12-01
23391969249120K992363SURESKIN II STANDARD, SURESKIN II BORDER, SURESKIN II THINFRO1999-08-12
23391812781427K991757NON-ABSORBABLE GAUZE FOR EXTERNAL USE, STERILE AND NON STERILEEFQ1999-08-12
23391548560275K991559MEDLINE PROHIBIT SERIES SURGICAL MASK WITH FLUID SHIELDFXX1999-08-23
23391839291517K990810ARGLAES-AB ANTIMICROBIAL BARRIER FILM DRESSING & ISLAND DRESSINGFRO1999-09-17
23391009589810K990463MEDLINE EXCEL WHEELCHAIRSIOR1999-03-15
23391306180962K982694MEDLINE MEDCREST SURGICAL GOWNS AND SURGICAL DRAPESFYA1998-12-14
23391810960734K982408AEROTEE, MODEL # 1001CAF1998-09-14
23391986990149K980798BIOSIGN H. PYLORI WB-NEW ONE-STEP ANTI-H. PYLORI ANTIBODY TESTLYR1998-09-22
23391615010639K974793ELMED ESU 120 M/M DIGITALGEI1998-03-19
23391566425514K972621PROFEEL POWDER FREE SURGICAL GLOVES (PROTEIN CONTENT LABELING)KGO1997-10-24
23391374172959K970946MEDLINE Y-TYPE TUR/BLADDER IRRIGATION SETLJH1997-06-10
23391537382200K964142MEDLINE DISPOSABLE SURGICAL DRAPES AND GOWNSKKX1997-02-25
23391029493675K963378MEDLINE ECONOMY LIMB HOLDER,DELUXE LIMB HOLDER,CINCH-TYPE LIMB HOLDER,PADDED LIMB HOLDER,ADJUSTABLE LIMB HOLDERFMQ1996-10-29
23391228839100K962205STERILE AND NON-STERILE O.R. TOWELS, STERILE AND NON-STERILE X-RAY DETECTABLE O.R. TOWELS, SINGLE USEKKX1996-11-26
23391569025768K962069MEDLINE PRE-POWDERED NON-STERILE/STERILE VINYL EXAMINATION GLOVESLYZ1996-08-19
23391843404588K962016MEDLINE TITANIUM HEMOCLIPSFZP1996-07-24
23391767008806K961758CARASYN HYDROGEL WOUND PRODUCTSMGQ1996-07-11
23392051721019K961024BIOSIGN MONO-PLUS WB,BIOSIGN MONO WB,MONO-PLUS WB,ACCUSIGN MONO WBKTN1997-02-04
23391560573352K960280IVAC NEEDLE FREE VALVE ADMINISTRATION SETSFPA1996-04-04
23391650284124K951736LOCK-UPFMI1995-07-05
23391220081613K940555SANDOZ NUTRITION COMPAT ENTERAL FEED PUMP W/HYDRATIONLZH1995-02-01
23391408349109K932654ELECTROSURGIAL INSTRUMENTSGEI1994-02-22
23391734152862K932449DR. FOGOCT1993-08-11
23392029876968K932291EUTRA GEL FOR WOUND DRESSINGMGQ1994-07-18
23391557845925K930525MICRO MIST(TM) NEBULIZERCAF1993-09-29
23391341225522K925167MASS SPECTROMETRY MONITORING LINE CONONECTORSCCK1993-01-22
23391458429210K912975OPERAND LUBRICATING JELLYKMJ1991-09-27
23392040362720K912132OPERAND LUBRICATING JELLYFHX1991-08-07
23391564140340K903083NEONATAL VENTILATOR CIRCUITBZO1990-12-27
23391728545840K902818MULTIPLE NONPOWERED NEUROSURGICAL INSTRUMENTHBG1990-09-20
23391824137242K900783MDI ADAPTORCAF1990-07-18
23391735701674K895231CATALOG NO. 1755 1S0-NEB, A FILTERED NEBULIZERCAF1989-10-27
23391509717942K891575COMPAT ENTERAL FEED PUMP 199235 & 199240LZH1989-09-12
23391086526819K881625CONCHATHERM III PLUS DUAL HEAT WIRE SERVO CONTROLLBZE1988-06-21
23392071506512K873955NAMIC ANGIOGRAPHIC SYRINGEDXT1988-02-05
23391814086344K871157C.P.A.P. NASAL CANNULABZD1987-04-21
23391061760368K854215DYNAFEEDKNT1985-12-02
23391211358638K850898MEDI-TRACE DISPOSABLE PRESSURE TRANSDUCERDRS1985-07-25
23391237950995K831974STOMACH TUBE LEVIN TUBEKNT1983-07-18
23391327146478K822100HIGH PRESSURE CONTRAST INJECTION LINEDQO1982-08-24
23391858037780K821970DYNACOR URETHRAL CATHETER TRAYKOD1982-07-21
23392071558554K820878CONCHO PEDIATRIC PACKBTT1982-05-03
23391812100240K820278INTRAVASCULAR ADMINISTRATION SETFPA1982-02-18
23391882576203K801199VOLDYNE VOLUMETRIC INCENTIVE DEEP BR. EXBWF1980-06-04
23391943006000K791495LUKENS BONE WAX (GAMMA RADIATION)MTJ1979-09-24
23391021898260K790108FILTERSET 0.22, I.V. PUMPFPA1979-03-06
23391278351208K790082ARTERIAL EXTENSION SETDQO1979-01-25
23391071920283K781831SPIROMETER, INCENTIVE CATALOG # 1750BWF1978-12-15
23391879773543K772348NEBULIZER ADAPTERCAF1978-01-03
23391921226570K770256CATHETERS, SILICONE COATEDKOD1977-02-17
23391216408308K761302ELECTRONIC BLOOD PRESSURE UNITDXN1977-01-05
23391982189985K760866CONCHA-COLUMNBTT1976-11-01
23391902535554K760489NEBULIZER, HANDHELD (T UP-DRAFT)CAF1976-09-03
23392062038154K253322Hudson RCI® Infant Dri-TechTM Breathing Circuits (HUD99060 / Dri-Tech with 78” Infant Circuit, HUD99060KIT / Dri-Tech with 78” Infant Circuit Kit, HUD99001KIT / Single Limb Infant Circuit Dri-Tech Kit, HUD99009KIT / Dri-Tech with 60” Infant Circuit Kit, HUD99018KIT / Dri-Tech with 44” Infant Circuit Kit, HUD870NKIT / Dri-Tech Infant Accessory Bag, HUD1631 / Infant Wye Connector with Swivel)BZE2026-03-25
23391817050068K253070Namic Radial Arm Band, 23 cm (DYNJRADBAND); Namic Radial Arm Band, 26 cm (DYNJRADBANDL)DXC2025-11-20
23391581186513K251687Konig Bell Circumcision ClampHFX2026-02-25
23392029566460K251563WELLlife Flu A&B Home Test; WELLlife Influenza A&B TestSCA2025-08-20
23391700893857K251138Promisemed Safety Huber NeedlesPTI2025-05-13
23391242496169K250312Hudson RCI® Comfort Flo Nasal Cannula Premature, Infant; Hudson RCI® Comfort Flo Plus and Soft Plus Cannula Extra SmallBTT2025-07-02
23391282373635K243888Medline UNITE® REFLEX® Hybrid Nitinol Implant SystemJDR2025-04-11
23391104803496K243431Medicom Sterilization Pouch and ReelFRG2025-02-21
23391501728343K242844Medline Level 4 Surgical Gown with Breathable SleevesFYA2025-02-26
23391062497309K242839Safe Secure Sterilization Pouches and RollsFRG2024-10-16
23391044373423K242370Medline Microdissection Needle (4cm) (140936 (ESE104A)); Medline Microdissection Needle (3cm) (140937 (ESE103A))GEI2024-12-19
23391887548343K242126I.V. Administration SetFPA2024-08-22
23391209918521K241778Hudson RCI Comfort Flo® CubCannula™BTT2024-12-19
23391881767460K241359Medline UNITE® MIS Foot Recon Screw SystemHWC2024-08-02
23391710393371K240163Hudson RCI® Comfort Flo Nasal Cannula; Hudson RCI® Comfort Flo Plus CannulaBTT2024-09-27
23391733121584K234132Medline Reusable Sterilization WrappersFRG2024-09-17
23391651961483K234032Hudson RCI Dri-Tech Breathing Circuits; HUD99035/Dri-Tech Adult Circuit; HUD99035KIT/Dri-Tech Adult Circuit Kit; HUD99098KIT/Single Limb Adult Dri-Tech Kit; HUD99098KITF/Single Limb Adult Dri-Tech Filter Kit; HUD900/Dri-Tech Ventilator Accessory; HUD901/Dri-Tech Ventilator Accessory Extension LineBZE2024-06-04
23391753291990K234031Medline UNITE Ancillary Foot Recon Plating SystemHRS2024-01-18
23391389621922K233615Electrosurgical Pads (GBS-Dm 1030ac, GBS-Db 1031ac, GBS-Dm 1030a, GBS-Db 1031a, GBS-Dm 1130ac, GBS-Db 1131ac, GBS-Dm 1130a, GBS-Db 1131a, GBS-Dm 1040ac, GBS-Db 1041ac, GBS-Dm 1040a, GBS-Db 1041a, GBS-Dm 1140ac, GBS-Db 1141ac, GBS-Dm 1140a, GBS-Db 1141a, GBS-Db 4030c, GBS-Db 4030, GBS-Db 4040c, GBS-Db 4040, GBS-Dm 1030bc, GBS-Db 1031bc, GBS-Dm 1030b, GBS-Db 1031b, GBS-Dm 1130bc, GBS-Db 1131bc, GBS-Dm 1130b, GBS-Db 1131b, GBS-Dm 1030nc, GBS-Db 1031nc, GBS-Dm 1030n, GBS-Db 1031n, GBS-Dm 1GEI2024-01-08
23391995311737K233526Medline Open-back Level 3 Protective GownQPC2024-03-05
23391379005549K233399Microdacyn Wound Care SolutionFRO2024-09-13
23391064498715K233151PluroGel® Antimicrobial Burn and Wound Dressing, PluroGel® Burn and Wound Dressing (OTC)FRO2024-03-26
23391178973917K232957Sterile and Non-Sterile Ultrasound GelsMUI2023-12-15
23391709169815K232905Medline UNITE® REFLEX® Nitinol Staple KitJDR2023-10-19
23391554149066K232230YJ-K1/K2 Wheelchair (YJ-K1F 16 NDE; YJ-K1F 16 NDS; YJ-K1F 18 NDE; YJ-K1F 18 NDS; YJ-K1F 20 NDE; YJ-K1F 20 NDS; YJ-K1F 18 NDEE; YJ-K1F 16 VDE; YJ-K1F 16 VDS; YJ-K1F 18 VDE; YJ-K1F 18 VDS; YJ-K1F 20 VDE; YJ-K1F 20 VDS; YJ-K2 16 VDFE; YJ-K2 16 VDFS; YJ-K2 18 VDFE; YJ-K2 18 VDFS; YJ-K2 20 VDFE; YJ-K2 20 VDFS; YJ-K1G 18 NFFE; YJ-K1G 18 NFFS; YJ-K2TC 16 NAFE; YJ-K2TC 18 NAFE; YJ-K2TC 20 NAFE)IOR2023-10-03
23391291102353K231907Medline Safety Insulin and TB SyringesMEG2023-10-18
23391151122774K231885Medline UNITE® REFLEX® Nitinol Staple SystemJDR2023-08-09
23391345344974K231401Polysafety BC, Polysafety BC Adva, Polywin Safety, Polywin Safety AdvaFOZ2023-09-21
23391873186536K231211Medline ComfortTemp Patient Warming SystemDWJ2023-12-01
23391042144545K231058Hudson RCI® AddiPak® Unit Dose VialCAF2024-01-04
23391590116638K230966angiOCCLUDE Ligating ClipsFZP2023-09-19
23391982634375K230616Polyguard and Polyshield Safety IV CathetersFOZ2023-05-05
23391683144601K230602Hudson RCI® TurboMist™ Nebulizer SystemCAF2023-10-31
23391567605315K230559Hudson RCI® Disposable Humidifier with 4 PSI Pressure Relief Valve (3230), Hudson RCI® Disposable Humidifier with 6 PSI Pressure Relief Valve (3260)BTT2023-10-26
23391000534969K230123Apollo Knotless Suture AnchorMBI2023-05-03
23391298437565K223399AViTA Pulse OximeterDQA2024-05-20
23391219266655K223360LUOFUCON® Silicone Ag+ Foam Dressing, LUOFUCON® Silicone Ag+ Antibacterial Foam DressingFRO2024-03-27
23391236589041K223236Medline Surgical Face Mask and Medline Procedural Face MaskFXX2023-03-24
23391118393459K223100Hudson RCI AquaTherm III Plus External Adjustable Electronic Heater (050-14)CAF2023-06-27
23392053559637K222978Poly-Tape/Infinity-Lock Soft Tissue Reinforcement DeviceQUW2022-12-27
23391746882048K222665Medline UNITE® Ankle Fusion Plating SystemHRS2023-01-25
23391208202829K221720Extra Silver Gelling Fiber DressingFRO2022-12-21
23391791092098K221360Medline UNITE® Medial Malleolus Peg Plate SystemHRS2022-09-27
23392033383900K221278Transducer Probe CoverITX2023-01-11
23391587552807K220955Hudson RCI Variable concentration Large Volume Nebulizer (1770)CAF2023-06-23
23391108799874K220739Disposable Urine Collection TubeJSM2022-11-17
23391123230088K220565Hudson RCI Triflo II Incentive Deep Breathing ExerciserBWF2022-10-25
23391278970991K220511Medline UNITE IM Fibula ImplantHWC2022-03-22
23391599865901K220370Safety Lancet (XIII, XVII, XXI, XXII, XXIII, XXIV, XXV, XXVI)FMK2022-05-19
23391570094928K220365Gemini Sterilization WrapFRG2022-10-06
23392016500304K220333Medline Orbis LVL 3 Surgical GownFYA2022-05-18
23391166072344K220288NP Medical nPulse K150 Neutral Displacement Needle Free Connector, nPulse Neutral displacement needle free connector, nPulse K150 Needle Free ConnectorFPA2023-04-19
23391963293487K220184Pump Alignment SyringeFMF2022-07-21
23391319534411K220006angioLOCK Polymer Ligating ClipFZP2022-03-02
23391626034975K214108Medline Orbis Chemo Surgical GownFYA2022-05-06
23391295570952K213567Medline UNITE Calcaneal Fracture Plating SystemHRS2022-03-02
23391916780270K213481Medline General Surgery TrayLRO2022-05-24
23391869128295K213068Medline Smoke Evacuation ShroudFYD2022-01-03
23391665121700K213054Medline Sure-Snap Safety Needle, Medline Sure-Snap Safety SyringeFMF2022-12-09
23391890234456K212911Konig Mogen ClampHFX2022-11-18
23391087757701K212623Healgen Strep A Rapid Test Strip (Throat Swab)GTY2022-03-16
23391502397932K212093Medline Universal Grounding PadGEI2022-01-14
23392020291162K211944Medline UNITE® Digital Fusion Screw SystemHWC2021-07-22

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
FRO342024-09-13
KGO242021-08-02
BTT172025-07-02
FRG162025-02-21
GEI152024-12-19
CAF152024-01-04
LYZ122021-07-17
LZA122020-10-26
FYA112025-02-26
FPA102024-08-22
HRS72024-01-18
HWC62024-08-02
MBI52023-05-03
FMF52022-12-09
HFX42026-02-25
JDR42025-04-11
DQA42024-05-20
BWF42022-10-25
FLL42021-09-20
JOW42017-09-08
DQO42017-01-19
EZL42015-01-09
MGQ42004-03-25
BZE32026-03-25
DXC32025-11-20
MEG32023-10-18
IOR32023-10-03
FOZ32023-09-21
FZP32023-09-19
PIF32019-12-04
KNT32019-05-04
KGN32015-06-26
KMF32014-07-10
FMI32014-05-29
KMJ32011-05-10
JHI32006-10-23
SCA22025-08-20
FXX22023-03-24
ITX22023-01-11
GTY22022-03-16