Company ยท US
Bio-Med USA, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1980 to 2022. Name variants (Inc, Corp, punctuation) are merged.
16510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 9, 2022 | K221789 | IRIS Pi Q switched Nd YAG laser Bio-Med USA, Inc. | GEX |
| Oct 6, 2021 | K212082 | Picore Bio-Med USA, Inc. | GEX |
| Nov 2, 2018 | K182270 | Cellene CO2 Laser System Bio-Med USA, Inc. | GEX |
| May 15, 2017 | K163638 | Dental 5 Multi Diode laser Bio-Med USA, Inc. | GEX |
| Mar 20, 2015 | K142332 | BT-400 Bio-Med USA | LBI |
| Sep 24, 2014 | K140837 | LUCID LY Bio-Med USA, Inc. | GEX |
| Jun 6, 2014 | K133774 | ATOVEN Bio-Med USA, Inc. | GEX |
| May 9, 2013 | K123710 | UNITOX BOTOX SYRINGE Bio-Med USA, Inc. | FMF |
| Dec 20, 2012 | K121268 | WANDY DISPERSVIE ELECTRODE Bio-Med USA, Inc. | ODR |
| Dec 19, 2011 | K111831 | MX-7000 MICROXEL Bio-Med USA, Inc. | ONG |
| Sep 8, 2008 | K081547 | BIO-MED SOFT INSULIN SYRINGE: MODELS 1CC, 0.5CC, 0.3CC Bio-Med USA, Inc. | FMF |
| Dec 30, 1982 | K823286 | MODELS DPT 1000/DPT 1000NS Bio-Med Corp. | DRS |
| May 8, 1981 | K810735 | DISPOSABLE, STERILE TRANSDUCER DOMES Bio-Med Corp. | DRS |
| Dec 18, 1980 | K802092 | HF-100 DIALYZER Bio-Med Corp. | FJI |
| Sep 9, 1980 | K802069 | DISP. TRANSDUCER DOMES TD200 & TD300 Bio-Med Corp. | DRS |
| Sep 9, 1980 | K801985 | BIO-MED CORP. DISP. NON-STERILE TRANSDU Bio-Med Corp. | DRS |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||