Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9611959

FEI Number

3002677549

Entity Name

AMD Medicom Inc.

City/State/Country

Pointe-Claire, Montreal Quebec, CA

Establishment Address

2555 Chemin de l'Aviation, Pointe-Claire, Montreal Quebec H9P 2Z2, CA

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Repack or Relabel Medical Device,Export Device to the United States But Perform No Other Operation on Device,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Medicom Group (Owner Number: 8020405)

Owner / Operator Contact Address

2555 Chemin De L Aviation, Pointe Claire, CA-QC H9P 2Z2, CA

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K051291

PMA Number

N/A

All Registered Proprietary Names

Medicom Vinyl Medical Examination Glove AMD-Ritmed Lab Jacket Medicom SafeWear Lab Coat Medicom SafeWear Jacket AMD-Ritmed Gown AMD-Ritmed Isolation Gown Ritmed Gown Medicom SafeWear Gown Medicom SafeBasics Gown AMD-Ritmed Lab Coat Sterile Polyisoprene Surgical Gloves Ritmed Neurological Sponge Medicom AssureCheck Type 5 Chemical Indicator Medicom AssureCheck Smart Biological Indicator Incubator Medicom AssureCheck Rapid Biological Indicator Medicom AssureCheck Multivariable Chemical Indicator Medicom Table Paper Medicom Earloop Molded Mask Medicom Earloop Cone Mask Nitrile Examination Gloves Tested For Use With Chemotheraphy Drugs-Blue Medicom Pediatric Mask Ritmed Pediatric Mask Hedy Cotton Dental Rolls Medicom Cotton Roll AMD-Ritmed Eye Pads Eye Pads Medicom Pro-Matrix Band Medicom SafeMask Hedy Patient Bibs Medicom Dental Bib Nitrile Disposable Examination Gloves (Tested For USE with Chemotherapy Drugs) O.R. Towel Tyvek Pouches and Tubing Medicom Denticare Pro-Polish Medicom Nitrile Powder-Free Examination glove tested with Chemotherapy Drugs (Blue) Medicom Sterilization Wrap Medicom Conforming Bandage Conforming Bandages; Polychloroprene Medical examination Gloves tested for Chemo Use AMD-Ritmed Self Seal Sterilization Pouch AMD-Ritmed Sterilization Reel Medicom Sterilization Reel Medicom Self Seal Sterilization Pouch Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs Polychloroprene Sterile Surgical Gloves AssureTouch Ultra Medicom Nitrile Powder-Free Examination glove tested with Chemotherapy Drugs (Pink) Pro-Tip Turbo Syringe Tip Pro-Tip Turbo Converter DentalEZ Pro-Syringe Pro-Tip Turbo Converter Engle Pro-Tip Turbo Converter DCI Pro-Tip Turbo Converter Adec Hedy Intra Oral Tips Hedy Air/Water Syringe Tip Solon Wooden Applicator Solon Spoon AMD-Ritmed N95 Respirator Medicom N95 Respirator Medicom Triangular Bandage AMD-Ritmed Laparotomy sponges AMD-Ritmed Gauze sponge AMD-Ritmed Gauze packing AMD-Ritmed Sticks sponge AMD-Ritmed Dissector Sponge AMD-Ritmed NW Sponge AMD-Ritmed Tonsil Sponge AMD-Ritmed O.R. Towel Medicom SafeSeal® Biological Indicator SafeGauze Hemostat Nitrile Medical Examination Gloves Tested For Use With Chemotherapy Drugs-Blue Medicom Duraflor Varnish Medicom Duraflor Halo Varnish Medicom Surgical/N95 Respirator AMD-Ritmed Boot Covers AMD-Ritmed Shoe Covers Medicom SafeBasics Shoe Covers Level 3 Isolation gown Medicom Protective Eyewear Nitrile Medical Examination Gloves tested with Chemotherapy Drugs Medicom Prophy Angle Solon Tip Applicator Purfybr Tip Applicator Medicom Tip Applicators Prophy Angle Medicom Self-Sealing sterilization pouches AMD-Ritmed Bouffant Caps AMD-Ritmed Surgeon Hoods Medicom SafeBasics Bouffant Caps Medicom SafeBasics Beard Covers AMD-Ritmed Adhesive Fabric Bandage AMD-Ritmed Transparent Dressing AMD-Ritmed Surgical Tape AMD-Ritmed Adhesive Plastic Bandage AMD-Ritmed Adhesive Tape AMD-Ritmed Island Dressing Non Sterile Powder-Free Nitrile Examination Gloves Medicom AssureTouch Shield AMD-Ritmed Mask Medicom SafeBasics Medicom SafeMask Medicom AssureMask

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LYZ	Vinyl Patient Examination Glove	General Hospital	Class 1	880.6250	2021-10-27
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2008-12-04
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2023-11-13
EFQ	Gauze/Sponge, Internal	Unknown	Class U	N/A	2009-09-09
FRC	Indicator, Biological Sterilization Process	General Hospital	Class 2	880.2800	2025-08-01
JOJ	Indicator, Physical/Chemical Sterilization Process	General Hospital	Class 2	880.2800	2025-08-01
FMW	Cover, Mattress (Medical Purposes)	General Hospital	Class 1	880.6190	2011-02-25
FXX	Mask, Surgical	General, Plastic Surgery	Class 2	878.4040	2013-03-10
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2024-04-04
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2024-04-04
OXZ	Pediatric/Child Facemask	General, Plastic Surgery	Class 2	878.4040	2019-10-03
EFN	Cotton, Roll	Dental	Class 1	872.6050	2007-05-31
HMP	Pad, Eye	General, Plastic Surgery	Class 1	878.4440	2011-11-08
DZN	Instruments, Dental Hand	Dental	Class 1	872.4565	2016-05-06
LBH	Varnish, Cavity	Dental	Class 2	872.3260	2016-10-26
FXX	Mask, Surgical	General, Plastic Surgery	Class 2	878.4040	2024-11-01
KHR	Absorber, Saliva, Paper	Dental	Class 1	872.6050	2011-10-18
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2025-02-18
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2025-02-18
FRL	Fiber, Medical, Absorbent	General Hospital	Class 1	880.5300	2023-04-13
FRG	Wrap, Sterilization	General Hospital	Class 2	880.6850	2025-01-07
EJR	Agent, Polishing, Abrasive, Oral Cavity	Dental	Class 1	872.6030	2014-03-17
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2021-10-27
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2021-10-27
QDO	Fentanyl And Other Opioid Protection Glove	General Hospital	Class 1	880.6250	2021-10-27
FRG	Wrap, Sterilization	General Hospital	Class 2	880.6850	2024-08-13
MHW	Dressing, Compression	General Hospital	Class 1	880.5075	2006-08-01
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2022-02-18
KCT	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	General Hospital	Class 2	880.6850	2007-12-10
QDO	Fentanyl And Other Opioid Protection Glove	General Hospital	Class 1	880.6250	2023-07-05
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2023-07-05
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2023-07-05
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2023-09-28
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2025-04-04
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2025-04-04
QDO	Fentanyl And Other Opioid Protection Glove	General Hospital	Class 1	880.6250	2025-04-04
OPJ	Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs	General Hospital	Class 1	880.6250	2025-04-04
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2021-10-27
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2021-10-27
ECB	Unit, Syringe, Air And/Or Water	Dental	Class 1	872.4565	2016-05-06
JRQ	Shaker/Stirrer	Clinical Chemistry	Class 1	862.2050	2011-01-13
ILC	Utensil, Eating	Physical Medicine	Class 1	890.5050	2011-01-13
MSH	Respirator, Surgical	General, Plastic Surgery	Class 2	878.4040	2011-08-02
ILI	Sling, Arm	Physical Medicine	Class 1	890.3640	2008-12-03
GDY	Gauze/Sponge, Internal, X-Ray Detectable	General, Plastic Surgery	Class 1	878.4450	2003-10-06
JOJ	Indicator, Physical/Chemical Sterilization Process	General Hospital	Class 2	880.2800	2024-11-01
FRC	Indicator, Biological Sterilization Process	General Hospital	Class 2	880.2800	2024-09-23
OLR	Oral Wound Dressing	Unknown	Class U	N/A	2021-12-24
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2022-02-22
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2022-02-22
QDO	Fentanyl And Other Opioid Protection Glove	General Hospital	Class 1	880.6250	2022-02-22
LBH	Varnish, Cavity	Dental	Class 2	872.3260	2016-05-06
MSH	Respirator, Surgical	General, Plastic Surgery	Class 2	878.4040	2021-12-17
FXP	Cover, Shoe, Operating-Room	General, Plastic Surgery	Class 1	878.4040	2008-12-03
FYC	Gown, Isolation, Surgical	General, Plastic Surgery	Class 2	878.4040	2023-08-28
FRG	Wrap, Sterilization	General Hospital	Class 2	880.6850	2024-04-24
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	2010-04-30
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2022-02-22
EGS	Handpiece, Contra- And Right-Angle Attachment, Dental	Dental	Class 1	872.4200	2026-02-23
KXG	Applicator, Absorbent Tipped, Sterile	General Hospital	Class 1	880.6025	2005-10-26
EGS	Handpiece, Contra- And Right-Angle Attachment, Dental	Dental	Class 1	872.4200	2024-09-23
FRG	Wrap, Sterilization	General Hospital	Class 2	880.6850	2023-03-22
FYF	Cap, Surgical	General, Plastic Surgery	Class 1	878.4040	2008-12-03
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2003-10-06
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2022-06-20
LYZ	Vinyl Patient Examination Glove	General Hospital	Class 1	880.6250	2016-03-22
FXX	Mask, Surgical	General, Plastic Surgery	Class 2	878.4040	2007-12-10

Official Correspondent

No official correspondent registered.

US Agent Details

Brent Geiger Business: United Medical Enterprise Email: bgeiger@medicom.com Phone: (763) 2189292

Related Public Records

Same Entity

Medicom Group

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3008132392	Medicom Asia-Pacific Holdings Limited. Taiwan Branch	Wujie Township Yilan, TW
3003230618	AR MEDICOM INC., (ASIA), LTD.	Hongkong Hong Kong, CN
3017425988	AMD MEDICOM INC.	Saint-Laurent Quebec, CA
3017949824	United Medical Enterprise, Inc.	Thomson, GA, US
3006691703	A.R. Medicom Inc. (Shanghai) Co., Ltd.	Shanghai, CN

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K052612	Shanghai Antares Industries, Inc.	DISPOSABLE POWDER FREE VINYL EXAM GLOVES WITH VITAMIN COMPLEX, NOPAL AND LANOLIN BLUE COLOR	2005-11-22
K120584	Wealth on (Jiangsu) Co., Ltd.	POWER FREE STRETCH VINYL PATIENT EXAMINATION GLOVES	2012-07-10
K220992	Ever Global (Vietnam) Enterprise Corporation	Disposable Powder Free Vinyl Exam Glove, Black/Blue/Purple	2022-10-19
K112610	Inpro Technology Device Factory	SYNTHETIC VINYL EXAMINATION GLOVES, POWDER FREE (AND MULTIPLE LABELS)	2011-12-05
K131340	Made Plastic Co., Ltd.	POWDER FREE YELLOW SYNTHETIC VINYL PATIENT EXAMINATION GLOVES	2014-09-09

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0027-2007	N/A	2	3M Comply 1248 Gas Plasma Chemical Indicator Strips for use in STERRAD 100, STERRAD 100S and STERRAD 50 Sterilization Systems. Indicator for hydrogen peroxide sterilant.

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3012304513	JIANGSU HUAYUAN MEDICAL TECHNOLOGY CO., LTD.	Dongtai Jiangsu, CN
3012317628	ZIBO LING YUN MEDICAL PRODUCTS CO., LTD.	Zibo Shandong, CN
3015477649	SHANDONG SHANGWEI MEDICAL PRODUCTS CO.,LTD	HEZE CITY Shandong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9611959. Last updated year: 2026. Please use registration number 9611959 when referencing this establishment in official correspondence.