Bomimed Inc
WINNIPEG, Manitoba, CA
BOMIMED INC. appears in FDA device records in WINNIPEG, Manitoba, CA. FDA records list no 510(k) clearances, no PMA records and one registered establishment. As of , FDA records show 3 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Bomimed Inc carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Brathwaites Oliver Medicalenforcement report, recall
510(k) clearance history
No 510(k) clearance records for this company in the ingested FDA data.
No 510(k) clearance records in the ingested FDA data.
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3003213883 | 3003213883 | BOMIMED INC. | 1-100 IRENE STREET, WINNIPEG, Manitoba R3T 4E1 CA | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-3238-2017 | BOMImed Disposable Fiber Optic Medium Laryngoscope Handle. Each handle is packaged in an individual peel pouch, 20 handles per box. The rigid laryngoscope handle is a device used along with a blade to examine and visualize a patient's airway and aid placement of a tracheal tube. | Potential for intermittent lighting (flickering) during use. | Class II | Terminated | |
| Z-0067-2017 | The Introes Pocket Bougie is an endotracheal tube introducer. The device is an endotracheal tube introducer and it is used as a guide during intubation. Anesthesiology. | The Introes Pocket Bougie an endotracheal tube introducer size 14 Fr (4.7mm) x 60 cm may break during intubation. | Class II | Terminated | |
| Z-1488-2012 | BOMImed Reusable Integrated Fiber Optic Laryngoscope Blades, MacIntosh and Miller styles - all sizes. Instrument is used to aid with intubation. | On 9/1/2010 BOMImed, Inc. Winnipeg, MB, Canada initiated a recall of their BOMImed Integrated Reusable Laryngoscope Blades (Macintosh & Miller styles - all sizes), Model #OL-32D0 to OL-32D4 & OL-32E00, OL-32E0, OL-32E1, OL-32E2, OL-32E3, OL-32E4. | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain