Bio-Med USA, Inc.
Paterson, NJ, US
Bio-Med USA, Inc. appears in FDA device records in Paterson, NJ. FDA records list 11 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 11
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 11 510(k) clearances for Bio-Med USA, Inc. between 2008 and 2022. The busiest year on record is 2014, with 2. The most recent is 2022, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2008 | 1 |
| 2011 | 1 |
| 2012 | 1 |
| 2013 | 1 |
| 2014 | 2 |
| 2015 | 1 |
| 2017 | 1 |
| 2018 | 1 |
| 2021 | 1 |
| 2022 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K221789 | IRIS Pi Q switched Nd YAG laser | GEX | Substantially Equivalent | |
| K212082 | Picore | GEX | Substantially Equivalent | |
| K182270 | Cellene CO2 Laser System | GEX | Substantially Equivalent | |
| K163638 | Dental 5 Multi Diode laser | GEX | Substantially Equivalent | |
| K142332 | BT-400 | LBI | Substantially Equivalent | |
| K140837 | LUCID LY | GEX | Substantially Equivalent | |
| K133774 | ATOVEN | GEX | Substantially Equivalent | |
| K123710 | UNITOX BOTOX SYRINGE | FMF | Substantially Equivalent | |
| K121268 | WANDY DISPERSVIE ELECTRODE | ODR | Substantially Equivalent | |
| K111831 | MX-7000 MICROXEL | ONG | Substantially Equivalent | |
| K081547 | BIO-MED SOFT INSULIN SYRINGE: MODELS 1CC, 0.5CC, 0.3CC | FMF | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain