Scorecard
Events per device across the 146-device portfolio, trailing 12 months. Arrows compare the last 90 days with the 90 before.
MAUDE reports per device
0 →
0 in the last 12 months
Higher volume than 83% of companies with 10+ devices
Recalls per device
0 →
0 in the last 12 months
Higher volume than 97% of companies with 10+ devices
These are reporting-volume percentiles, not safety rankings — MAUDE counts have no denominator of devices in use, and recall attribution follows resolved links. A high percentile means more reports per registered device than peers, which can reflect market size, device criticality, or reporting practice as much as anything else.
Devices
146 device records · ordered by linked event volume.
| Brand | Model | Product codes | Primary DI | Linked events |
|---|
| Electrode, Holter, Button, 1 ea., MP2E-01 | Model 1200 | DSH | 00817980020702 | 1 |
| Electrodes, Holter, Button, 20 per Box, MP2E-20 | Model 1200 | DSH | 00817980020689 | 1 |
| Electrodes, Holter, Button, 40 per Box, MP2E-40 | Model 1200 | DSH | 00817980020696 | 1 |
| Vasomedical-Biox™ 1805 Ambulatory Blood Pressure Monitor With Analysis S/W | Model 1805 | DSH | 00817980020047 | 1 |
| Vasomedical-Biox™ 2302 Combined 12 Channel ECG Holter & ABP Monitor | Model 2302 | DSH | 00817980020085 | 1 |
| Vasomedical-Biox™ 1200 ECG Holter Mini Recorder | Model 1200 | DSH | 00817980020344 | 1 |
| Vasomedical-Biox™ 1806 ABP Monitor With Analysis S/W | Model 1806 | DSH | 00817980020054 | 1 |
| Vasomedical-Biox™ 1807 ABP Monitor With Analysis S/W w/ Bluetooth | Model 1807 | DSH | 00817980020061 | 1 |
| Vasomedical-Biox™ Model 1200 2 CH Mini ECG Recorder | Model 1200 Kit | DSH | 00817980020368 | 1 |
| Vasomedical-Biox™ Model 1805 Ambulatory Blood Pressure Recorder | Model 1805 Kit | DSH | 00817980020467 | 1 |
| Vasomedical-Biox™ Model 1806 Ambulatory Blood Pressure Recorder | Model 1806 Kit | DSH | 00817980020474 | 1 |
| Vasomedical-Biox™ Model 1807 Ambulatory Blood Pressure Recorder w/Bluetooth | Model 1807 Kit | DSH | 00817980020481 | 1 |
| Vasomedical-Biox™ Model 2304 12 CH/ABP COMB Recorder | Model 2304 Kit | DSH | 00817980020528 | 1 |
| Vasomedical-Biox™ Model 2306 12 CH/ABP COMB Recorder w/Bluetooth | Model 2306 Kit | DSH | 00817980020542 | 1 |
| 12-Ch ECG Holter Patient Cable w/10 Leads | Model 1304 | DSH | 00817980020580 | 0 |
| 2GB SD Memory Card | Model 1303 | DSH | 00817980020559 | 0 |
| 3 Lead Integrated ECG Cable (AngioNew® V & VI) | Model AngioNew VI | DRN | 00817980020870 | 0 |
| 3 Lead Integrated ECG Cable (Models MC2, TS4 and Lumenair™) | Model Lumenair | DRN | 00817980020887 | 0 |
| 3 Lead Integrated ECG Cable with adapter (Model TS3) | Model TS3 | DRN | 00817980020894 | 0 |
| 3-Ch ECG Holter Patient Cable w/5 Leads | Model 1303 | DSH | 00817980020566 | 0 |
| 3-Ch ECG Holter Patient Cable w/7 Leads | Model 1303 | DSH | 00817980020573 | 0 |
| Adult BP Cuff (large) 32-42cm | Model 1805 | DSH | 00817980020665 | 0 |
| Adult BP Cuff (standard) 24-32cm | Model 1805 | DSH | 00817980020658 | 0 |
| AnKle Strap | Model Lumenair | DRN | 00817980021211 | 0 |
| Bladder Set, Large | Model Lumenair | DRN | 00817980021129 | 0 |
| Bladder Set, Medium | Model Lumenair | DRN | 00817980021099 | 0 |
| Bladder Set, Small | Model Lumenair | DRN | 00817980021112 | 0 |
| Bladder Set, X-Large (should be used with XL and XXL cuffs) | Model Lumenair | DRN | 00817980021105 | 0 |
| Bladder Set, X-Small | Model Lumenair | DRN | 00817980021082 | 0 |
| Calf Cuff, Small, Medium & Large | Model Lumenair | DRN | 00817980021051 | 0 |
Showing 1–30 of 146Next → Facilities
Registered establishments with their latest FDA inspection outcome.
| FEI | Name | Location | Last inspection | Watch |
|---|
| 3007663004 | Biox Instruments Co Ltd | Wuxi Jiangsu, CN | VAI | |
| 2435300 | VASOMEDICAL, INC. | Plainview, NY, US | VAI | |