Data / Medical devices / Canada / Instrumentarium Surgical Corp., Inc.
Instrumentarium Surgical Corp., Inc.: FDA-registered device maker in TERREBONNE Quebec, Canada, 1 510(k) clearance
Instrumentarium Surgical Corp., Inc. is registered with the FDA (registration 9615857) in TERREBONNE Quebec, Canada. It lists 76 device types. The FDA files 1 510(k) clearance under its listings, the newest dated December 12, 2018. Registered through 2026. FDA data exported November 3, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 9615857
- FEI number
- 3002409980
- Address
- 1273 Rue Saint-Louis, TERREBONNE Quebec, Canada, J6W 1K6
- Owner or operator
- INSTRUMENTARIUM SURGICAL CORP., INC. (9041885)
- Roles
- Exporter to the US, Repackager or relabeler
- First device listed
- June 19, 2000
- Registered through
- 2026
- Brand names listed
- HEBU, INSTRUMENTARIUM, INSTRUMENTARIUM SURGICAL CORP. INC., Instrumentarium, instrumentarium
Devices it lists
| Device | Product code | Class | Role | Source |
|---|
| Applicator, Ent | KCJ | 1 | Repackager or relabeler | accessdata.fda.gov |
| Burr, Corneal, Manual | HOF | 1 | Repackager or relabeler | accessdata.fda.gov |
| Caliper, Ophthalmic | HOE | 1 | Repackager or relabeler | accessdata.fda.gov |
| Camera, Cine, Endoscopic, Without Audio | FWL | 1 | Repackager or relabeler | accessdata.fda.gov |
| Cannula, Ear | JYC | 1 | Repackager or relabeler | accessdata.fda.gov |
| Cannula, Ophthalmic | HMX | 1 | Repackager or relabeler | accessdata.fda.gov |
| Cannula, Sinus | KAM | 1 | Repackager or relabeler | accessdata.fda.gov |
| Cannula, Surgical, General & Plastic Surgery | GEA | 1 | Repackager or relabeler | accessdata.fda.gov |
| Chisel, Surgical, Manual | FZO | 1 | Repackager or relabeler | accessdata.fda.gov |
| Compressor, Orbital | HOA | 1 | Repackager or relabeler | accessdata.fda.gov |
| Curette, Ear | JYG | 1 | Repackager or relabeler | accessdata.fda.gov |
| Curette, Nasal | KAP | 1 | Repackager or relabeler | accessdata.fda.gov |
| Curette, Ophthalmic | HNZ | 1 | Repackager or relabeler | accessdata.fda.gov |
| Curette, Surgical, General Use | FZS | 1 | Repackager or relabeler | accessdata.fda.gov |
| Device, Percutaneous, Biopsy | MJG | 1 | Repackager or relabeler | accessdata.fda.gov |
| Dissector, Surgical, General & Plastic Surgery | GDI | 1 | Repackager or relabeler | accessdata.fda.gov |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | 2 | Exporter to the US | accessdata.fda.gov |
| Elevator, Ent | KAD | 1 | Repackager or relabeler | accessdata.fda.gov |
| Elevator, Surgical, General & Plastic Surgery | GEG | 1 | Repackager or relabeler | accessdata.fda.gov |
| Forceps, Ent | KAE | 1 | Repackager or relabeler | accessdata.fda.gov |
| Forceps, General & Plastic Surgery | GEN | 1 | Repackager or relabeler | accessdata.fda.gov |
| Forceps, Ophthalmic | HNR | 1 | Repackager or relabeler | accessdata.fda.gov |
| Gouge, Nasal, Ent | KAQ | 1 | Repackager or relabeler | accessdata.fda.gov |
| Holder, Needle, Gastroenterologic | FHQ | 1 | Repackager or relabeler | accessdata.fda.gov |
| Holder, Speculum, Ent | KAG | 1 | Repackager or relabeler | accessdata.fda.gov |
| Hook, Microsurgical Ear | JYL | 1 | Repackager or relabeler | accessdata.fda.gov |
| Hook, Ophthalmic | HNQ | 1 | Repackager or relabeler | accessdata.fda.gov |
| Hook, Surgical, General & Plastic Surgery | GDG | 1 | Repackager or relabeler | accessdata.fda.gov |
| Instrument, Cutting, Orthopedic | HTZ | 1 | Repackager or relabeler | accessdata.fda.gov |
| Instrument, Ent Manual Surgical | LRC | 1 | Repackager or relabeler | accessdata.fda.gov |
| Instrument, Manual, General Obstetric-Gynecologic | KOH | 1 | Repackager or relabeler | accessdata.fda.gov |
| Instrument, Manual, Surgical, General Use | MDM | 1 | Repackager or relabeler | accessdata.fda.gov |
| Knife, Ent | KTG | 1 | Repackager or relabeler | accessdata.fda.gov |
| Knife, Laryngeal | JZY | 1 | Repackager or relabeler | accessdata.fda.gov |
| Knife, Nasal | KAS | 1 | Repackager or relabeler | accessdata.fda.gov |
| Knife, Ophthalmic | HNN | 1 | Repackager or relabeler | accessdata.fda.gov |
| Knife, Surgical | EMF | 1 | Repackager or relabeler | accessdata.fda.gov |
| Mallet | HXL | 1 | Repackager or relabeler | accessdata.fda.gov |
| Mirror, Ent | KAI | 1 | Repackager or relabeler | accessdata.fda.gov |
| Needle, Aspiration And Injection, Reusable | GDM | 1 | Repackager or relabeler | accessdata.fda.gov |
| Needle, Suturing, Reusable | GDL | 1 | Repackager or relabeler | accessdata.fda.gov |
| Osteotome | HWM | 1 | Repackager or relabeler | accessdata.fda.gov |
| Probe, Ent | KAK | 1 | Repackager or relabeler | accessdata.fda.gov |
| Probe, Lachrymal | HNL | 1 | Repackager or relabeler | accessdata.fda.gov |
| Punch, Corneo-Scleral | HNJ | 1 | Repackager or relabeler | accessdata.fda.gov |
| Punch, Ent | KTF | 1 | Repackager or relabeler | accessdata.fda.gov |
| Punch, Nasal | KAY | 1 | Repackager or relabeler | accessdata.fda.gov |
| Punch, Surgical | LRY | 1 | Repackager or relabeler | accessdata.fda.gov |
| Rasp, Ear | JYY | 1 | Repackager or relabeler | accessdata.fda.gov |
| Rasp, Surgical, General & Plastic Surgery | GAC | 1 | Repackager or relabeler | accessdata.fda.gov |
| Retractor | GAD | 1 | Repackager or relabeler | accessdata.fda.gov |
| Retractor, Ent | KAL | 1 | Repackager or relabeler | accessdata.fda.gov |
| Retractor, Ophthalmic | HNI | 1 | Repackager or relabeler | accessdata.fda.gov |
| Retractor, Self-Retaining | FFO | 1 | Repackager or relabeler | accessdata.fda.gov |
| Ring, Ophthalmic (Flieringa) | HNH | 1 | Repackager or relabeler | accessdata.fda.gov |
| Rongeur, Lachrymal Sac | HNG | 1 | Repackager or relabeler | accessdata.fda.gov |
| Rongeur, Mastoid | JZA | 1 | Repackager or relabeler | accessdata.fda.gov |
| Rongeur, Nasal | KBB | 1 | Repackager or relabeler | accessdata.fda.gov |
| Saw, Nasal | KBC | 1 | Repackager or relabeler | accessdata.fda.gov |
| Scissors, Ear | JZB | 1 | Repackager or relabeler | accessdata.fda.gov |
| Scissors, General, Surgical | LRW | 1 | Repackager or relabeler | accessdata.fda.gov |
| Scissors, Nasal | KBD | 1 | Repackager or relabeler | accessdata.fda.gov |
| Scissors, Ophthalmic | HNF | 1 | Repackager or relabeler | accessdata.fda.gov |
| Snare, Ear | JZD | 1 | Repackager or relabeler | accessdata.fda.gov |
| Snare, Nasal | KBE | 1 | Repackager or relabeler | accessdata.fda.gov |
| Snare, Surgical | GAE | 1 | Repackager or relabeler | accessdata.fda.gov |
| Spatula, Ophthalmic | HND | 1 | Repackager or relabeler | accessdata.fda.gov |
| Specula, Ophthalmic | HNC | 1 | Repackager or relabeler | accessdata.fda.gov |
| Speculum, Ent | EPY | 1 | Repackager or relabeler | accessdata.fda.gov |
| Stripper, Vein, Reusable | GAI | 1 | Repackager or relabeler | accessdata.fda.gov |
| Tap, Bone | HWX | 1 | Repackager or relabeler | accessdata.fda.gov |
| Tray, Surgical, Instrument | FSM | 1 | Repackager or relabeler | accessdata.fda.gov |
| Trephine, Manual, Ophthalmic | HRH | 1 | Repackager or relabeler | accessdata.fda.gov |
| Trephine, Sinus | KBF | 1 | Repackager or relabeler | accessdata.fda.gov |
| Trocar, Ent | KTE | 1 | Repackager or relabeler | accessdata.fda.gov |
| Tube, Ear Suction | JZF | 1 | Repackager or relabeler | accessdata.fda.gov |
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 |
|---|
| December 12, 2018 | K182812 | Medline Cautery Electrode (SILICONE) | GEI | Substantially Equivalent | Medline Industries, Inc. | accessdata.fda.gov |
Compare with other makers
Updated December 12, 2018. 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.