Bovie Medical Corporation
Bovie Medical Corporation has 15 FDA recalls, 0 inspections, 23 510(k) clearances and 0 compliance actions on record.
- Latest recall
- Z-1155-2021 · Class II · Feb 1, 2021
- Latest 510(k)
- Mar 12, 2019
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Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 15 | Oct 23, 2026 | Not stated | Current |
| 510(k) clearances | 23 | Oct 4, 2026 | Not stated | Current |
| Inspections | 0 | Oct 26, 2026 | Not stated | Current |
| Compliance actions | 0 | Oct 23, 2026 | Not stated | Current |
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-1155-2021 | Class II | ConMed Disposable Bipolar Ablators - Product Usage: intended to be used for cutting, vaporization… | Feb 1, 2021 |
| Z-1154-2021 | Class II | HNM Disposable Bipolar Ablators - Product Usage: intended to be used for cutting, vaporization, and… | Feb 1, 2021 |
| Z-1153-2021 | Class II | Velocity Disposable Bipolar Ablators - Product Usage: intended to be used for cutting, vaporization… | Feb 1, 2021 |
| Z-2060-2020 | Class II | Renuvion/ J-Plasma Precise Open Handpiece. Catalog numbers BVX-044-BPS, BVX-044-BPP, BVX-150-BPP… | Apr 20, 2020 |
| Z-2061-2020 | Class II | Renuvion/ J-Plasma Precise Handpiece. Catalog numbers BVX-150B, BVX-270B, BVX-330B, BVX-270BPP… | Apr 20, 2020 |
| Z-0198-2019 | Class II | J-Plasma Precise 360, single use, disposable. The Bovie J-Plasma Precise 360 Handpiece is used… | Jun 18, 2018 |
| Z-1154-2018 | Class II | J-Plasma Precise(R), Catalog Numbers: BVX-150B, BVX-150N, BVX-330B, BVX- 330N, BVX-450B, BVX-450N | Feb 8, 2018 |
| Z-1157-2018 | Class II | J-Plasma Precise(R) FLEX, Catalog Number: BVX-500BF | Feb 8, 2018 |
| Z-1155-2018 | Class II | J-Plasma(R) Handpiece, Catalog Numbers: GS-018C, GS-270C, BVX-270B | Feb 8, 2018 |
| Z-1153-2018 | Class II | J-Plasma Precise(R) OPEN, Catalog Numbers: BVX-044-BPP, BVX-044-BPS, BVX-150-BPP, BVX-150-BPS | Feb 8, 2018 |
| Z-1156-2018 | Class II | J-Plasma Precise 360(R), Catalog Numbers: BVX-330BR, BVX-330NR, BVX-450BR, BVX-450NR | Feb 8, 2018 |
| Z-2647-2016 | Class II | BVX-330NR Bovie Precise 360 Handpiece 33cm, needle Product is used for the delivery of helium… | Jul 18, 2016 |
| Z-2646-2016 | Class II | BVX-330BR Bovie Precise 360 Handpiece 33cm, blade Product is used for the delivery of helium… | Jul 18, 2016 |
| Z-2648-2016 | Class II | BVX-450BR Bovie Precise 360 Handpiece 45cm, blade Product is used for the delivery of helium gas… | Jul 18, 2016 |
| Z-2649-2016 | Class II | BVX-450NR Bovie Precise 360 Handpiece 45cm, needle Product is used for the delivery of helium… | Jul 18, 2016 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K183610 | Renuvion/J-Plasma Precise Handpiece, Renuvion/J-Plasma Precise Open handpieces, Renuvion/J-Plasma… | Mar 12, 2019 |
| K180211 | Freezpoint | Mar 21, 2018 |
| K170777 | Bovie J-Plasma Precise FLEX Handpiece | May 1, 2017 |
| K170188 | Bovie J-Plasma Precise Open handpiece & Bovie Ultimate Gen 2 High Frequency Electrosurgical… | Mar 8, 2017 |
| K161558 | Bovie 3.3mm Disposable Bipolar Ablator 90°, Aspirating and Non-Aspirating, Bovie 2.4mm Disposable… | Jul 29, 2016 |
| K161134 | Bovie Bantam/PRO Electrosurgical Generator, Bovie DERM 941 Electrosurgical Generator, Bovie DERM 942… | Jun 20, 2016 |
| K152777 | Bovie Disposable Bipolar Ablator | Jan 15, 2016 |
| K152570 | Bovie J-Plasma Precise 360 Handpiece | Nov 2, 2015 |
| K151325 | Bovie J-Plasma Handpiece | Aug 4, 2015 |
| K142975 | Bovie Ultimate High Frequency Electrosurgical Generator | Dec 12, 2014 |
| K134054 | BOVIE IDS-310 HIGH FREQUENCY ELECTROSURGICAL GENERATOR, AARON A3350 HIGH FREQUENCY ELECTROSURGICAL… | Mar 17, 2014 |
| K121441 | CAUTERY; LOW TEMPERATURE (FINEADJUSTABLE FINE TIP, ELONGATED FINE TIP, MICRO FINE TIP) | Jul 20, 2012 |
| K112233 | BOVIE J-PLASMA HANDPIECE WITH RETRACTABLE CUTTING BLADE | Jan 27, 2012 |
| K092149 | BOSS COAGULATION DEVICE, MODEL BOSS1215, BOSS COAGULATION DEVICE, ANGLED ACCESS, MODEL BOSA1215 | Mar 18, 2010 |
| K092383 | BOVIE ICON VS GENERAL PURPOSE RF GENERATOR, MODEL: VS300 | Mar 10, 2010 |
| K093025 | BOVIE RESISTICK II COATED ELECTROSURGICAL ELECTRODES | Dec 22, 2009 |
| K091440 | LAPAROSCOPIC RESECTION DEVICE, MODEL SR326L | Oct 9, 2009 |
| K090586 | BOVIE ICON GS ELECTROSURGICAL GENERATOR (GS100), HANDPIECE (GS-OP-R), REUSABLE HANDPIECE CABLE… | Aug 7, 2009 |
| K082568 | SALINE ENHANCED ELECTROSURGICAL RESECTION (SEER) DEVICE | Nov 17, 2008 |
| K082109 | BOVIE ICON GENERAL PURPOSE RF GENERATOR | Oct 2, 2008 |