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StrongArm Surgical Holders and Positioners
FLEXBAR MACHINE CORPORATION · Model 38000-D · UDI-DI 00842102116087
10
510(k) clearances
225
Adverse events (1 deaths)
75
Recalls
153
Facilities
Description
Bronchoscope Dual Stabilization System with rigid arm, fixed Tip and Mount Post with Flexible Arm, fixed Tip incl. Rail Clamp & Storage Case
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-07-24 | QUANTUM OPS Inc | Due to a manufacturing issue (inadequate weld) for patient head positioning system. |
| 2021-09-13 | Innovative Orthopedic Technologies, LLC | Due to the holes not being bored to the specific diameter, the locking pins are unable to engage under a load. |
| 2016-10-06 | The Anspach Effort, Inc. | Supplied Directions for Use (DFU) did not contain a recommended service interval. |
| 2016-10-06 | The Anspach Effort, Inc. | Supplied Directions for Use (DFU) did not contain a recommended service interval. |
| 2016-10-06 | The Anspach Effort, Inc. | Supplied Directions for Use (DFU) did not contain a recommended service interval. |
| 2016-10-06 | The Anspach Effort, Inc. | Supplied Directions for Use (DFU) did not contain a recommended service interval. |
| 2016-10-06 | The Anspach Effort, Inc. | Supplied Directions for Use (DFU) did not contain a recommended service interval. |
| 2016-10-06 | The Anspach Effort, Inc. | Supplied Directions for Use (DFU) did not contain a recommended service interval. |
| 2016-10-06 | The Anspach Effort, Inc. | Supplied Directions for Use (DFU) did not contain a recommended service interval. |
| 2016-10-06 | The Anspach Effort, Inc. | Supplied Directions for Use (DFU) did not contain a recommended service interval. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.