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
- 510(k)K230271Substantially equivalent (SESE) · 2023-03-28clearance family
Predicate lineage
- K230271
Cited as predicate by: K243042
Lineage each submission cites, walked transitively (indented = the cited device's own predicates). Extracted from public 510(k) summary text — heuristic, and includes reference devices mentioned alongside true predicates.
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2023-09-20 | NAI | No action indicated | Varian Medical Systems, Inc. | 0 |
| 2023-09-20 | NAI | No action indicated | Varian Medical Systems, Inc. | 0 |
| 2022-09-07 | NAI | No action indicated | Varian Medical Systems, Inc. | 0 |
| 2017-09-01 | NAI | No action indicated | Varian Medical Systems, Inc. | 0 |
| 2017-07-20 | VAI | Voluntary action indicated | VARIAN MEDICAL SYSTEMS HAAN GMBH | 2 |
| 2017-01-12 | VAI | Voluntary action indicated | Varian Medical Systems Imaging Laboratory GmbH | 1 |
| 2016-12-15 | NAI | No action indicated | Varian Medical Systems, Inc. | 0 |
| 2016-12-15 | NAI | No action indicated | Varian Medical Systems, Inc. | 0 |
| 2016-08-31 | NAI | No action indicated | Varian Medical Systems Inc | 0 |
| 2016-08-10 | NAI | No action indicated | Varian Medical Systems, Inc. | 0 |
| 2016-08-10 | NAI | No action indicated | Varian Medical Systems, Inc. | 0 |
| 2016-01-15 | NAI | No action indicated | Varian Medical Systems, Inc. | 0 |
| 2016-01-15 | NAI | No action indicated | Varian Medical Systems, Inc. | 0 |
| 2015-07-10 | NAI | No action indicated | Varian Medical Systems, Inc. | 0 |
| 2015-07-10 | NAI | No action indicated | Varian Medical Systems, Inc. | 0 |
| 2015-05-20 | VAI | Voluntary action indicated | Varian Medical Systems, Inc. | 2 |
| 2015-05-20 | VAI | Voluntary action indicated | Varian Medical Systems, Inc. | 2 |
| 2014-06-06 | NAI | No action indicated | Varian Medical Systems, Inc. | 0 |
| 2014-06-06 | NAI | No action indicated | Varian Medical Systems, Inc. | 0 |
| 2014-06-02 | NAI | No action indicated | Varian Medical Systems Inc | 0 |
| 2010-05-17 | WL | Warning Letter | Varian Medical Systems, Inc. | — |
| 2010-05-17 | WL | Warning Letter | Varian Medical Systems, Inc. | — |
Similar devices
- 1.0in x 16g Straight Spray Needle BRYMILL CORPORATION
- 1.0in x 18g Straight Spray Needle BRYMILL CORPORATION
- 1.0in x 20g Straight Spray BRYMILL CORPORATION
- 1.0in x 20g Straight Spray Needle BRYMILL CORPORATION
- 1.5in x 20g Bent Spray BRYMILL CORPORATION
- 1.5x3mm Mini Probes BRYMILL CORPORATION
- 10mm Cryochamber BRYMILL CORPORATION
- 15mm Cryochamber BRYMILL CORPORATION
- 18mm Cryochamber BRYMILL CORPORATION
- 19mm Domed Cervical Probes BRYMILL CORPORATION
- 19mm Flat Cervical Probes BRYMILL CORPORATION
- 19x5x5mm Cervical Probes BRYMILL CORPORATION
Select up to two to place side-by-side with this device.