B & K Medical Systems, Inc.
North Billerica, MA
B & K Medical Systems, Inc. appears in FDA device records in North Billerica, MA. FDA records list no 510(k) clearances, no PMA records and no registered establishments. As of , FDA records show 3 recalls for this company.
FDA records held for this company
- 510(k) clearances
- 0
- PMA records
- 0
- Recall records
- 3
- Registered establishments
- 0
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
No FDA establishment registrations recorded against this company.
FDA product codes
No FDA product codes recorded against this company.
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1140-2008 | B-K Medical Intraoperative Transducer Type 8814, diagnostic ultrasound transducer, B-K Medical Systems, Inc., Wilmington, MA 01887 | Crack: Incomplete glue joint in the device housing may affect electrical safety or sterilization. | Terminated | ||
| Z-0856-06 | Convex Array Transducer used with B-K Ultrasound Scanners Model number: 8667 | Due to a problem with calibration, the device can produce up to 50% elevated acoustic output and up to 2 degrees higher surface temperature | Terminated | ||
| Z-0271-05 | Linear Array Transducer Type: 8809 | Defect at probe tip may effect sterilization and electrical safety | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain