Data / Medical devices / Canada / Medisca Pharmaceutique Inc.
Medisca Pharmaceutique Inc.: FDA-registered device maker in St-Laurent Quebec, Canada, 7 510(k) clearances
Medisca Pharmaceutique Inc. is registered with the FDA (registration 3013428737) in St-Laurent Quebec, Canada. It lists 13 device types. The FDA files 7 510(k) clearances under its listings, the newest dated November 28, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3013428737
- FEI number
- 3000305308
- Address
- 4509 Rue Dobrin, St-Laurent Quebec, Canada, H4R 2L8
- Owner or operator
- MEDISCA INC. (9054511)
- Roles
- Exporter to the US, Foreign private label distributor, Repackager or relabeler, Specification developer
- First device listed
- March 7, 2003
- Registered through
- 2026
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 28, 2023 | K232252 | Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Black), Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Orange) | LZA | Substantially Equivalent | Dehai (Shandong) Medical Gloves, Co., Ltd. | accessdata.fda.gov |
| March 29, 2021 | K202191 | Surgical Mask | FXX | Substantially Equivalent | Wuhan Zonsen Medical Products Co., Ltd. | accessdata.fda.gov |
| March 22, 2019 | K182554 | Powder Free Nitrile Examination Gloves, Blue, Tested for Use with Chemotherapy Drugs | LZA | Substantially Equivalent | He Chuang Plastic & Rubber Co., Ltd. | accessdata.fda.gov |
| November 20, 2018 | K181857 | Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Low Dermatitis Potential. Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | LZA | Substantially Equivalent | Kossan International Sdn Bhd | accessdata.fda.gov |
| August 3, 2016 | K151750 | Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Powder Free Nitrile Patient Examination Glove, White Colored, Non-Sterile | LZA | Substantially Equivalent | Kossan International Sdn Bhd | accessdata.fda.gov |
| January 8, 2008 | K072067 | N95 SURGICAL RESPIRATOR, TYPE AP0018 AND AP0028 | MSH | Substantially Equivalent | Shuenn Bao Shing Corporation | accessdata.fda.gov |
| March 4, 1988 | K875227 | STERILE EMPTY VIALS | LDH | Substantially Equivalent | Allertech, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Fentanyl And Other Opioid Protection Glove
- All makers of Medical Glove, Specialty
- All makers of Polymer Patient Examination Glove
- All makers of Container, Liquid Medication, Graduated
- All makers of Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs
- All makers of Micro Pipette
Updated November 28, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.