COGENTIX MEDICAL, INC.
14 inspections · 2 clearances · 2 recalls · 1 adverse events · aggregated across 3 source records
Scorecard
Events per device across the 48-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
48 device records · ordered by linked event volume.
| Brand | Model | Product codes | Primary DI | Linked events |
|---|---|---|---|---|
| Portable LED Light Source | BLS-1000 | EOB | 00874485000318 | 3 |
| UNITY 9000 | UVP-9000 | EOB EOQ EOX FAJ OCS | 00874485003227 | 1 |
| UNITY 9100 | UVP-9100 | EOB EOQ EOX FAJ OCS | 00874485003210 | 1 |
| EndoSheath Technology | CF-2.1 | HIH | 00874485003142 | 0 |
| EndoSheath Technology | BV-0 | EOQ | 00874485003098 | 0 |
| EndoSheath Technology | BF-0 | EOQ | 00874485003050 | 0 |
| EndoSheath Technology | BF-1.5 | EOQ | 00874485003036 | 0 |
| EndoSheath Technology | BVX-2.1 | EOQ | 00874485003104 | 0 |
| EndoSheath Technology | CV-1.5 | FAJ | 00874485003173 | 0 |
| EndoSheath Technology | CF-1.5 | HIH | 00874485003159 | 0 |
| EndoSheath Technology | TV-2.1 | EOX | 00874485002985 | 0 |
| EndoSheath Technology | BVX-0 | EOQ | 00874485003135 | 0 |
| EndoSheath Technology | BVX-2.8 | EOQ | 00874485003128 | 0 |
| EndoSheath Technology | BVX-1.5 | EOQ | 00874485003111 | 0 |
| EndoSheath Technology | BV-1.5 | EOQ | 00874485003074 | 0 |
| EndoSheath Technology | BV-2.1 | EOQ | 00874485003067 | 0 |
| EndoSheath Technology | BF-2.8 | EOQ | 00874485003043 | 0 |
| EndoSheath Technology | BF-2.1 | EOQ | 00874485003029 | 0 |
| EndoSheath Technology | TV-1.5 | EOX | 00874485003005 | 0 |
| EndoSheath Technology | CV-2.1 | FAJ | 00874485003166 | 0 |
| Endoscopic Cytology Brush | 07-9001 | FDX | 00874485003180 | 0 |
| Endoscopic Injection Needle | 07-9005 | FBK | 00874485002749 | 0 |
| Flexible Fiber Bronchoscope | BRS-4000 | EOQ | 00874485001544 | 0 |
| Flexible Fiber Laryngoscope, Standard Set | ENT-4500 | EOB | 00874485001629 | 0 |
| Flexible Fiber Laryngoscope, Standard Set | ENT-4000 | EOB | 00874485001360 | 0 |
| Flexible Fiber Laryngoscope, Standard Set Reconditioned | ENT-4000 | EOB | 00874485002954 | 0 |
| Flexible Fiber Laryngoscope, Standard Set Reconditioned | ENT-4500 | EOB | 00874485002947 | 0 |
| Flexible Fiberoptic Cystoscope | CST-4000 | HIH | 00874485001599 | 0 |
| Flexible Fiberoptic Cystoscope - Intuitive | CST-4000i | HIH | 00874485001605 | 0 |
| Flexible Video Bronchoscope (NTSC) | BRS-5100 | EOQ | 00874485002367 | 0 |
Showing 1–30 of 48Next →
Facilities
Registered establishments with their latest FDA inspection outcome.
| FEI | Name | Location | Last inspection | Watch |
|---|---|---|---|---|
| 1000136543 | COGENTIX MEDICAL, INC. | Westborough, MA, US | NAI | |
| 2242464 | COGENTIX MEDICAL, INC. | ORANGEBURG, NY, US | VAI |