Adverse-event reports (MAUDE)
Read this first: MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.
No adverse-event reports are linked to this device.
Recall history
No recalls linked.
Regulatory clearances
None linked.
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2022-06-08 | NAI | No action indicated | HK Surgical Inc | 0 |
| 2022-06-08 | NAI | No action indicated | HK Surgical Inc | 0 |
| 2018-09-25 | NAI | No action indicated | HK Surgical Inc | 0 |
| 2018-09-25 | NAI | No action indicated | HK Surgical Inc | 0 |
Similar devices
- "Connector, Tube 51mm 1/2""" Geister Medizintechnik GmbH
- "DEL VECCHIO 12-HOLE, 4MM, 1"" BLUE ERGO" The Wells Johnson Company
- 1-HOLE STANDARD The Wells Johnson Company
- 10 mm Flexible Cannula T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION
- 10mm x 30mm Flexible Cannula (5 units) T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION
- 10mm x 50mm Flexible Cannula Conmed (5 units) T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION
- 10x30 mm Flexible Cannula T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION
- 12 mm Flexible Cannula T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION
- 12-HOLE HARVESTING The Wells Johnson Company
- 12mm x 40mm Flexible Cannula (5 units) T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION
- 14MM HANDLE Biomet Orthopedics, LLC
- 16MM HANDLE Biomet Orthopedics, LLC
Select up to two to place side-by-side with this device.