FDA Registration
Active
🇨🇦 Canada
KM Medical
Reg #: 3013517171
·
FEI: 3013517171
·
Expires 2026
Products
47
Proprietary Names
15
Establishment Types
1
Classifications
47
Registration Details
- Registration Name
- KM Medical
- Registration Number
- 3013517171
- FEI Number
- 3013517171
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 640 Petrolia Rd
- City
- North York Ontario
- Country
- CA
Regulatory Submissions
- 510(k) Number
- K030573
Owner / Operator
- Firm Name
- KM Medical
- Operator Number
- 10054719
- Address
- 640 Petrolia Rd
- City
- North York
- State
- Ontario
- Postal Code
- M3J 2W3
- Country
- CA
- Correspondent
- Khalid Mahmoud
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Tubes, Vials, Systems, Serum Separators, Blood Collection | JKA | Class 2 | Clinical Chemistry | No | 2022-05-18 |
| Set, Administration, Intravascular | FPA | Class 2 | General Hospital | No | 2022-05-18 |
| Electrode, Electrocardiograph | DRX | Class 2 | Cardiovascular | No | 2018-02-22 |
| Catheter, Urological | KOD | Class 2 | Gastroenterology, Urology | No | 2026-03-24 |
| Bag, Urine Collection, Leg, For External Use, Sterile | FAQ | Class 1 | Gastroenterology, Urology | No | 2025-04-23 |
| Brush, Scrub, Operating-Room | GEC | Class 1 | General, Plastic Surgery | No | 2022-01-19 |
| Stopcock, I.V. Set | FMG | Class 2 | General Hospital | No | 2024-06-03 |
| Set, Blood Transfusion | BRZ | Class 2 | General Hospital | No | 2023-08-02 |
| Syringe, Irrigating (Non Dental) | KYZ | Class 1 | General Hospital | No | 2025-02-06 |
| Otoscope | ERA | Class 1 | Ear, Nose, Throat | No | 2020-02-18 |
| Surgeon'S Gloves | KGO | Class 1 | General, Plastic Surgery | No | 2017-07-27 |
| Support, Patient Position | CCX | Class 1 | Anesthesiology | No | 2023-01-24 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2018-02-22 |
| Blood Pressure Cuff | DXQ | Class 2 | Cardiovascular | No | 2020-02-18 |
| Device, Intravascular Catheter Securement | KMK | Class 1 | General Hospital | No | 2021-03-16 |
| Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | FOZ | Class 2 | General Hospital | No | 2020-09-23 |
| Bedding, Disposable, Medical | KME | Class 1 | General Hospital | No | 2023-01-16 |
| Wound Dressing With Animal-Derived Material(S) | KGN | Class U | Unknown | No | 2017-10-31 |
| Monitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas Anesthesia | LPP | Class 2 | Anesthesiology | No | 2023-05-05 |
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2020-02-18 |
| Tubes, Vacuum Sample, With Anticoagulant | GIM | Class 2 | Clinical Chemistry | No | 2025-06-18 |
| Container, Liquid Medication, Graduated | KYW | Class 1 | General Hospital | No | 2024-01-03 |
| Drape, Surgical, Exempt | PUI | Class 2 | General, Plastic Surgery | No | 2021-03-15 |
| System, Transport, Aerobic | JTW | Class 1 | Microbiology | No | 2025-05-27 |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2020-02-18 |
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2020-02-18 |
| Needle, Hypodermic, Single Lumen | FMI | Class 2 | General Hospital | No | 2020-09-23 |
| Syringe, Piston | FMF | Class 2 | General Hospital | No | 2020-09-23 |
| Arthroscope | HRX | Class 2 | Orthopedic | No | 2023-08-02 |
| System, Irrigation, Urological | LJH | Class 2 | Gastroenterology, Urology | No | 2023-08-02 |
| Dressing, Wound, Occlusive | NAD | Class 1 | General, Plastic Surgery | No | 2017-10-31 |
| Dressing, Wound, Hydrophilic | NAC | Class 1 | General, Plastic Surgery | No | 2025-04-14 |
| Dressing, Compression | MHW | Class 1 | General Hospital | No | 2023-01-16 |
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 2020-12-10 |
| Device, Transfer, Patient, Manual | FMR | Class 1 | General Hospital | No | 2021-01-29 |
| Latex Patient Examination Glove | LYY | Class 1 | General Hospital | No | 2017-07-27 |
| Automated External Defibrillators (Non-Wearable) | MKJ | Class 3 | Cardiovascular | No | 2018-02-22 |
| Filter, Infusion Line | FPB | Class 2 | General Hospital | No | 2024-04-04 |
| Bronchoscope Accessory | KTI | Class 2 | Ear, Nose, Throat | No | 2018-02-22 |
| Catheter, Coude | EZC | Class 2 | Gastroenterology, Urology | No | 2022-03-24 |
| Container, Specimen, Sterile | FMH | Class 1 | Pathology | No | 2025-05-27 |
| Apparatus, Suction, Single Patient Use, Portable, Nonpowered | GCY | Class 1 | General, Plastic Surgery | No | 2023-08-02 |
| Speculum, Vaginal, Nonmetal | HIB | Class 2 | Obstetrics/Gynecology | No | 2020-05-13 |
| Container, I.V. | KPE | Class 2 | General Hospital | No | 2023-08-02 |
| Suture, Nonabsorbable, Synthetic, Polypropylene | GAW | Class 2 | General, Plastic Surgery | No | 2021-12-28 |
| Blood/Plasma Collection Device For Dna Testing | PJE | Class 2 | Clinical Chemistry | No | 2025-09-08 |
| Container, Specimen Mailer And Storage, Sterile | KDT | Class 1 | Pathology | No | 2025-11-21 |
Proprietary Names
Tubes, vials, systems, serum separators, blood collection
Medline Canada, Viscot, Becton dickinson Canada
Conveen Contour; Conveen Security+
BD Single Sample Luer Adapter; BD Vacutainer Single Sample Luer A
Tiemann Catheter
PULSE OXIMETER
Masimo
Syringe, piston
ALLDRESS; Exufiber; LYOFOAM Dressings (A, C, T, Extra); LYOFOAM MAX; Melgisorb Plus; Mepilex; Mepilex Border; Mepilex Bo
Catheter
BD Sharps Collectors
TUBE, BLD COLL VAC
BD 1ml Insulin Syringe U-100 Luer-Lok Tip; BD 1mL Luer-Lok Hypodermic Syringe; BD 1mL Luer-Lok Hypodermic Syringe wit
BD Blood Collection Set; BD Safety Lok Blood Collection Set
CATHETER, COUDE
Establishment Types
Export Device to the United States But Perform No Other Operation on Device