Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007289408

FEI Number

3007289408

Entity Name

Medline Canada

City/State/Country

Guelph Ontario, CA

Establishment Address

995 Southgate Road, Guelph Ontario N1L 0B9, CA

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

Medline Industries, LP (Owner Number: 1417592)

Owner / Operator Contact Address

Three Lakes Drive, Northfield, IL 60093, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Medline / Konig Snare, Tonsil MEDLINE / CDS PLASTIC SURGERY KIT AND ACCESSORIES NAMIC Contrast Injection Line Medline Medline Basin Kit Centurion Basin Kit Medline Medicine Cup Medline Triangular Graduate Container Medline surgical kits/trays and CDS modules MEDLINE General surgery tray (kit) Medline / Eclipse / Aurora / Sirus surgical packs Convenience Trays & Kits CSTM Medline Proxima DYNACOR CONTAINERS Medline/Centurion Sterile Bowl, Sterile Pitcher Medline Pathology Container Centurion Pathology Container Medline Midstream Collection Kit Medline Specimen Container Medline Medline / Konig Holder, Needle, Gastroenterologic Medline Baumgartner Needle Holder Medline CURAD HeelMedix CURAD Performance Series Medline Raised Toilet Seat Medline Transfer Bench TOILET SAFETY RAIL Medline Commode Bucket GUARDIAN MEDLINE ADAPTOR, HYGIENE - ILS Caring+ Optifoam Gentle Surgical Max Optifoam Gentle SA Optifoam Gentle Liquitrap (LQ) Optifoam Gentle Heel Optifoam Gentle Lite Medline Wound Dressing Optifoam SureSite Optifoam Gentle Stratasorb Opticell Gelling Fiber Wound Dressing Medline Bordered Gauze Adhesive Island Versatel Optiview Optifoam Basic Optifoam Heel Exuderm Low Profile (LP) CURAD Exuderm Satin Optifoam Gentle EX Essentials Optifoam Site Equos CURAD Naturals Medline Optifoam Gentle Post-Op Medline / Konig Cannula, Surgical, General & Plastic Surgery MEDLINE BOTTLE, COLLECTION, VACUUM - KDQ Medline bottle liner Medline Suction Canisters / Suction Canister Soft Liners suction canisters SensiCare Sterile Power-Free Polymer Coated Polyisoprene Surgical Glove, Coated with Aloe Vera SensiCare PI Green BULKEE II CURAD BULKEE LITE Caring abdominal pads CURAD Naturals Medline Abdominal Pad Medline ACCU-SORB Medline / Konig Speculum, Vaginal, Metal ST.PEDERSON VAGINAL SPECULUM MEDLINE / CENTURION STERILE GRAVES VAGINAL SPECULUM MEDLINE / CENTURION STERILE VAGINAL SPECULUM Medline Catheter Leg Strap Medline Urethral Catheter Holder Medline Foley Catheter Securement Device Unna Medline Elastic Bandage Unna-Z CURAD Threeflex Bandages Fourflex Medline Elastic Retention Netting CoFlex LF2 Medline Stockinette CoFlex Sure-Wrap Elastic Bandage ACCU-SORB Matrix Microtek Esmark TwoFlex Accu-Wrap Protection Plus Disposable Underpads Medline Disposable Underpads FitRight Ultrasorb, Extrasorb, Therasorb, Drypad, Underpads OREX MEDICAL BEDDING DISPOSABLE BEDDING CleanOp: bedding and cleaning supplies Microtek Disposable Baby Blanket Extrasorb MICROTEK DISPOSABLE BEDDING FitRight Extended Use Underpad BEDDING Ultrasorb MEDICAL GENERAL HOSPITAL ComfortGlide Drypad Guardian K1 Medline / CDS laparoscopy kit Medline / Konig Splint, Hand, and Components Centurion Forceps Medline / Konig Forceps, General & Plastic Surgery Medline Isolation Gown Thumbs Up Medline Procedure Gown NAMIC Contrast Management System NAMIC Contrast Controller NAMIC Squeeze Contrast Controller Medline / CDS orthopedic tray (kit) Medline UNITE DEXTACK Optifoam Post-Op Ag+ Optifoam Ag+ Optifoam Gentle Ag+ Medline Tracheobronchial Suction Catheter Kit Medline D407 Series Sleeved Suction Catheter Kit Medline Suction Catheter Mini Tray Medline D409 Series Suction Catheter Kit Medline Suction Catheter Kit Medline / Konig Cannula, Surgical, General & Plastic Surgery Medline Cardiovascular Procedure Kit Medline Maternity Knit Underpants FitRight Cloth-Like Adult Incontinence Briefs FitRight Underwear FitRight Booster Pad FitRight ActivEdge Underwear FitRight EasyFlex Brief FitRight Extended Wear Underwear Medline Belted Briefs FitRight ActivEdge Male Guard FitRight ActivEdge Bladder Control Pads Medline Mesh Underpants MEDLINE ENDOTRACHEAL TUBE Medline Medline Secureview SorbaView 2000 Medline SeeIV SorbaView SorbaView SHIELD HubGuard Eclipse Surgical Drape Medline Surgical Drape Medline Keyboard Cover Medline Band Bag Medline Set Up Cover Vari-Lens Lingeman Procept AKTORmed Microtek Patient Drapes Medline Dome Bag Convertors Vital Care Perfect Pouch OnLume Medline Poly-lined Drape Medline Poly-lined Fenestrated Drape Medline Equipment Cover Microtek Probe Cover Microtek Equipment Drapes Medline Breathing Circuit Medline Adult Expandable Anesthesia Circuit Hudson RCI Nasal Cannula Medline Boot Covers Medline Shoe Covers

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
CAH	Filter, Bacterial, Breathing-Circuit	Anesthesiology	Class 2	868.5260	2009-01-16
KBZ	Snare, Tonsil	Ear, Nose, Throat	Class 1	874.4420	2015-03-31
FTN	Plastic Surgery And Accessories Kit	General, Plastic Surgery	Class 1	878.3925	2011-09-15
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2021-10-21
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2021-10-21
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2019-10-24
FNY	Basin, Emesis	General Hospital	Class 1	880.6730	1991-12-30
KYW	Container, Liquid Medication, Graduated	General Hospital	Class 1	880.6430	1977-12-29
LRO	General Surgery Tray	General, Plastic Surgery	Class 2	878.4370	2019-02-28
FMH	Container, Specimen, Sterile	Pathology	Class 1	864.3250	1992-01-09
IQK	Orthosis, Cervical	Physical Medicine	Class 1	890.3490	2026-05-01
FHQ	Holder, Needle, Gastroenterologic	Gastroenterology, Urology	Class 1	876.4730	2015-03-31
ITW	Joint, Ankle, External Brace	Physical Medicine	Class 1	890.3475	2016-06-27
ILS	Adaptor, Hygiene	Physical Medicine	Class 1	890.5050	2001-11-05
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2012-04-04
GEA	Cannula, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2015-03-31
KDQ	Bottle, Collection, Vacuum	General Hospital	Class 2	880.6740	2008-07-17
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2024-04-18
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2002-12-13
HDF	Speculum, Vaginal, Metal	Obstetrics/Gynecology	Class 1	884.4520	2015-03-31
EYJ	Holder, Ureteral Catheter	Gastroenterology, Urology	Class 1	876.5130	1991-12-30
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2005-02-01
KME	Bedding, Disposable, Medical	General Hospital	Class 1	880.6060	2014-10-20
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2020-03-02
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2020-03-02
IOR	Wheelchair, Mechanical	Physical Medicine	Class 1	890.3850	2026-05-27
FDE	Laparoscopy Kit	Gastroenterology, Urology	Class 2	876.1500	2010-08-09
ILH	Splint, Hand, And Components	Physical Medicine	Class 1	890.3475	2006-11-13
GEN	Forceps, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2015-03-31
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2012-08-30
IZI	System, X-Ray, Angiographic	Radiology	Class 2	892.1600	2019-11-04
OJH	Orthopedic Tray	General, Plastic Surgery	Class 1	878.4800	2010-08-09
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2016-09-19
OFR	Tracheobronchial Suction Catheter Kit	Anesthesiology	Class 1	868.6810	2008-07-09
GEA	Cannula, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2015-03-31
OEZ	Cardiovascular Procedure Kit	Cardiovascular	Class 2	870.1200	2008-07-15
EYQ	Garment, Protective, For Incontinence	Gastroenterology, Urology	Class 1	876.5920	1992-01-01
BTR	Tube, Tracheal (W/Wo Connector)	Anesthesiology	Class 2	868.5730	2016-06-27
HHW	Pessary, Vaginal	Obstetrics/Gynecology	Class 2	884.3575	2026-05-27
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	2015-04-08
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2020-10-16
KMK	Device, Intravascular Catheter Securement	General Hospital	Class 1	880.5210	2018-04-06
PUI	Drape, Surgical, Exempt	General, Plastic Surgery	Class 2	878.4370	2017-08-25
CAI	Circuit, Breathing (W Connector, Adaptor, Y Piece)	Anesthesiology	Class 1	868.5240	2006-04-11
CAT	Cannula, Nasal, Oxygen	Anesthesiology	Class 1	868.5340	1979-10-01
FXP	Cover, Shoe, Operating-Room	General, Plastic Surgery	Class 1	878.4040	1992-06-15

Official Correspondent

Stephanie Augsburg

US Agent Details

Rosanna Lee Business: Simcon International LLC Email: rlee@simconintl.com Phone: (847) 9492290

Related Public Records

Same Entity

Medline Industries, LP

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3007128716	Medline Industries, LP	Norristown, PA, US
3036706541	EXCELSIOR MEDICAL LLC	Tinton Falls, NJ, US
3016073670	Medline Logistics Japan G.K.	Nishihocho, Aisai-shi Aichi, JP
3006581049	MICROTEK MEDICAL MALTA LIMITED	Mosta, MT
3010389834	Microtek Medical B.V. Varsseveld	VARSSEVELD Gelderland, NL

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K962045	Mallinckrodt Medical	ANESTHESIA BREATHING CIRCUIT/ANESTHESIA BREATHING KIT	1996-11-26
K002933	Maxxim Medical	STERILE SENSICARE SYNTHETIC POLYISOPRENE POWDER-FREE SURGICAL GLOVES	2000-10-19
K913402	Smith & Nephew Perry	PERRY(R) DERMAGUARD(R) PLUS GLOVES	1991-10-02
K151126	Colibri Technologies, Inc.	Foresight Intracardiac Echocardiography (ICE) System	2015-12-18
K931629	Carapace, Inc.	CARAPACE ANGIOGRAPHY TRAYS	1993-12-06

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0027-2025	Windstone Medical Packaging, Inc.	2	Aligned Medical Tonsil Tray REF AMS9300A that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.
Z-0028-2025	Windstone Medical Packaging, Inc.	2	Aligned Medical Tonsil ENT Pack REF AMS9977 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.
Z-0030-2025	Windstone Medical Packaging, Inc.	2	Aligned Medical T and A Pack REF AMS11482 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.
Z-0031-2025	Windstone Medical Packaging, Inc.	2	Aligned Medical Tonsil Pack REF AMS14809 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.
Z-0095-2021	Alcon Research, LLC	2	Alcon Custom-Pak Surgical Procedure Packs containing Cardinal Health" PROTEXIS" Latex Micro Surgical Gloves - Product Usage: used by ophthalmic surgeons in a variety of ophthalmic surgeries.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007289408. Last updated year: 2026. Please use registration number 3007289408 when referencing this establishment in official correspondence.