Bovie Medical Corporation
Bovie Medical Corporation holds FDA 510(k) medical device clearances, first cleared 2009, most recent 2019, with 15 FDA device recalls on record.
Top product codes for Bovie Medical Corporation
FDA recalls by Bovie Medical Corporation
10 most recent of 15- Z-1155-2021 — ConMed Disposable Bipolar Ablators - Product Usage: intended to be used for cutting, vaporization, and coagulation of soft tissue during arthroscopic surgical procedures.
- Z-1153-2021 — Velocity Disposable Bipolar Ablators - Product Usage: intended to be used for cutting, vaporization, and coagulation of soft tissue during arthroscopic surgical procedures.
- Z-1154-2021 — HNM Disposable Bipolar Ablators - Product Usage: intended to be used for cutting, vaporization, and coagulation of soft tissue during arthroscopic surgical procedures.
- Z-2060-2020 — Renuvion/ J-Plasma Precise Open Handpiece. Catalog numbers BVX-044-BPS, BVX-044-BPP, BVX-150-BPP, BVX-150-BPS, APYX-044-BPS, APYX-150-BPP, and APYX-150-BPS - Product Usage: for electrosurgical cutting, coagulation and ablation of soft tissue during open surgical procedures.
- Z-2061-2020 — Renuvion/ J-Plasma Precise Handpiece. Catalog numbers BVX-150B, BVX-270B, BVX-330B, BVX-270BPP, BVX- 330BPS, APYX-150B, APYX-270B, APYX-330B, APYX- 270BPP, and APYX-330BPS. Product Usage: for electrosurgical cutting, coagulation and ablation of soft tissue during open and laparoscopic surgical procedures.
- Z-0198-2019 — J-Plasma Precise 360, single use, disposable. The Bovie J-Plasma Precise 360 Handpiece is used for the delivery of helium gas plasma for cutting, coagulation, and ablation of soft tissue during open and laparascopic surgical procedures.
- Z-1153-2018 — J-Plasma Precise(R) OPEN, Catalog Numbers: BVX-044-BPP, BVX-044-BPS, BVX-150-BPP, BVX-150-BPS
- Z-1154-2018 — J-Plasma Precise(R), Catalog Numbers: BVX-150B, BVX-150N, BVX-330B, BVX- 330N, BVX-450B, BVX-450N
- Z-1157-2018 — J-Plasma Precise(R) FLEX, Catalog Number: BVX-500BF
- Z-1156-2018 — J-Plasma Precise 360(R), Catalog Numbers: BVX-330BR, BVX-330NR, BVX-450BR, BVX-450NR
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Bovie Medical Corporation
- K183610 — Renuvion/J-Plasma Precise Handpiece, Renuvion/J-Plasma Precise Open handpieces, Renuvion/J-Plasma Precise Open handpieces
- K170777 — Bovie J-Plasma Precise FLEX Handpiece
- K170188 — Bovie J-Plasma Precise Open handpiece & Bovie Ultimate Gen 2 High Frequency Electrosurgical Generator
- K161558 — Bovie 3.3mm Disposable Bipolar Ablator 90°, Aspirating and Non-Aspirating, Bovie 2.4mm Disposable Bipolar Ablator 55°, Non-Aspirating, Bovie 1.8mm Disposable Bipolar Ablator 60°, Non-Aspirating
- K161134 — Bovie Bantam/PRO Electrosurgical Generator, Bovie DERM 941 Electrosurgical Generator, Bovie DERM 942 Electrosurgical Generator
- K152777 — Bovie Disposable Bipolar Ablator
- K152570 — Bovie J-Plasma Precise 360 Handpiece
- K151325 — Bovie J-Plasma Handpiece
- K142975 — Bovie Ultimate High Frequency Electrosurgical Generator
- K134054 — BOVIE IDS-310 HIGH FREQUENCY ELECTROSURGICAL GENERATOR, AARON A3350 HIGH FREQUENCY ELECTROSURGICAL GENERATOR
- K121441 — CAUTERY; LOW TEMPERATURE (FINEADJUSTABLE FINE TIP, ELONGATED FINE TIP, MICRO FINE TIP)
- K112233 — BOVIE J-PLASMA HANDPIECE WITH RETRACTABLE CUTTING BLADE
- K092383 — BOVIE ICON VS GENERAL PURPOSE RF GENERATOR, MODEL: VS300
- K093025 — BOVIE RESISTICK II COATED ELECTROSURGICAL ELECTRODES
Data sourced from openFDA. This site is unofficial and independent of the FDA.