BEUDAMED
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    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.

    FDA Enforcement
    Class II ·Terminated·Bovie Medical Corporation·May 27, 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.

    FDA Enforcement
    Class II ·Terminated·Bovie Medical Corporation·May 27, 2020

    J-Plasma Precise(R), Catalog Numbers: BVX-150B, BVX-150N, BVX-330B, BVX- 330N, BVX-450B, BVX-450N

    FDA Enforcement
    Class II ·Terminated·Bovie Medical Corporation·March 28, 2018

    J-Plasma Precise 360(R), Catalog Numbers: BVX-330BR, BVX-330NR, BVX-450BR, BVX-450NR

    FDA Enforcement
    Class II ·Terminated·Bovie Medical Corporation·March 28, 2018

    J-Plasma Precise(R) OPEN, Catalog Numbers: BVX-044-BPP, BVX-044-BPS, BVX-150-BPP, BVX-150-BPS

    FDA Enforcement
    Class II ·Terminated·Bovie Medical Corporation·March 28, 2018

    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.

    FDA Enforcement
    Class II ·Terminated·Bovie Medical Corporation·October 31, 2018

    2.3mm Turbo-Power OTW, Manual, Model No 423-050 Product Usage The Turbo-Power System (Laser Atherectomy Catheter) is a laser atherectomy device designed for use with the CVX-300" Excimer Laser System. The Turbo-Power Laser Atherectomy Catheter is a sterile, single use, prescription only device used for peripheral atherectomy. Turbo-Power is used exclusively with SPNC s CVX 300" Excimer Laser System and is a Type CF device, Defibrillation proof. Turbo-Power is a laser atherectomy catheter designed for treatment of de novo or restenotic lesions in native infrainguinal arteries and for the treatment of femoropopliteal artery in-stent restenosis (ISR) in bare nitinol stents, with adjunctive Percutaneous Transluminal Angioplasty (PTA). Turbo-Power is used to directionally ablate infrainguinal concentric and eccentric lesions in vessels that are 3.5 mm or greater in diameter. The device is comprised of three parts: the working length of the catheter shaft (also the applied part), the motor drive unit (MDU), and the proximal laser shaft which connects the catheter fiber optics to the CVX-300" Excimer Laser System.

    FDA Enforcement
    Class II ·Terminated·Spectranetics Corp.·February 17, 2016

    Philips EPIQ Diagnostic Ultrasound System; Model Numbers: EPIQ Elite, EPIQ 5G, EPIQ 5C, EPIQ 7G, EPIQ 7C, EPIQ CVx & EPIQ CVxi. MOD EPIQ Elite DIAGNOSTIC ULTRASOUND SYSTEM; Rx Only 100-240V~50/60 Hz, 600 VA MOD EPIQ 5 DIAGNOSTIC ULTRASOUND SYSTEM; GMDN 40761, Rx Only, 100-240V~50/60 Hz, 600VA MOD EPIQ 7 DIAGNOSTIC ULTRASOUND SYSTEM; GMDN 40761, Rx Only, 100-240V~50/60 Hz, 600VA MOD EPIQ DIAGNOSTIC ULTRASOUND SYSTEM; Rx Only,100-240V~50/60 Hz, 600VA

    FDA Enforcement
    Class II ·Terminated·Philips Ultrasound Inc·February 10, 2021

    J-Plasma Precise(R) FLEX, Catalog Number: BVX-500BF

    FDA Enforcement
    Class II ·Terminated·Bovie Medical Corporation·March 28, 2018

    BVX-330BR Bovie Precise 360 Handpiece 33cm, blade Product is used for the delivery of helium gas plasma for cutting, coagulation, and ablation of soft tissue during open and laparoscopic surgical procedures.

    FDA Enforcement
    Class II ·Terminated·Bovie Medical Corporation·August 31, 2016

    BVX-330NR Bovie Precise 360 Handpiece 33cm, needle Product is used for the delivery of helium gas plasma for cutting, coagulation, and ablation of soft tissue during open and laparoscopic surgical procedures.

    FDA Enforcement
    Class II ·Terminated·Bovie Medical Corporation·August 31, 2016

    BVX-450BR Bovie Precise 360 Handpiece 45cm, blade Product is used for the delivery of helium gas plasma for cutting, coagulation, and ablation of soft tissue during open and laparoscopic surgical procedures.

    FDA Enforcement
    Class II ·Terminated·Bovie Medical Corporation·August 31, 2016

    BVX-450NR Bovie Precise 360 Handpiece 45cm, needle Product is used for the delivery of helium gas plasma for cutting, coagulation, and ablation of soft tissue during open and laparoscopic surgical procedures.

    FDA Enforcement
    Class II ·Terminated·Bovie Medical Corporation·August 31, 2016

    AngioJet AVX Thrombectomy Set: UPN 105039-001, Catalog No.105039, Sterilized Using Ethylene Oxide. For breaking apart and removing thrombus from vascular system, used with the AngioJet Ultra System in breaking apart and removing thrombus from A-V access conduits.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific Corporation·August 19, 2015

    J-Plasma(R) Handpiece, Catalog Numbers: GS-018C, GS-270C, BVX-270B

    FDA Enforcement
    Class II ·Terminated·Bovie Medical Corporation·March 28, 2018

    Elana Surgical KitHUD The Elana Surgical KitHUD, when connected to the Spectranetics Xenon-Chloride Laser Model CVX-300, is indicated for creating arteriotomies during an intracranial vascular bypass procedure in patients 13 years of age or older with an aneurysm or a skull base tumor affecting a large [> 2.5 mm], intracranial artery that failed balloon test occlusion, cannot be sacrificed, or cannot be treated with conventional means due to local anatomy or complexity

    FDA Enforcement
    Class II ·Terminated·Elana, Inc.·December 14, 2016

    ELCA Coronary Atherectomy Catheter. Models: 110-001, 110-002, 110-004, 114-009, 117-016, 117-205, 120-009 The Laser Catheters are used in conjunction with the Spectranetics CVX-300¿ Excimer Laser System and are intended for use in patients with single or multivessel coronary artery disease, either as a stand-alone modality or in conjunction with Percutaneous Transluminal Coronary Balloon Angioplasty (PTCA), and who are acceptable candidates for coronary artery bypass graft (CABG) surgery.

    FDA Enforcement
    Class II ·Terminated·Spectranetics Corporation·December 7, 2016

    All EPIQ and Affiniti Ultrasound systems. Model numbers - EPIQ 5G, EPIC 5C, EPIQ 5W, EPIQ 7G, EPIC 7C, EPIQ 7W, EPIQ CVx, Affiniti 30, Affiniti 50, Affiniti 70. Diagnostic Ultrasound System. MOD - EPIQ 5 GMDN - 40761 100-240V 50/60 Hz, 600 VA MOD - EPIQ 7 GMDN - 40761 100-240V 50/60 Hz, 600 VA MOD - EPIQ 100-240V 50/60 Hz, 600 VA MOD - Affinity 30 GMDN - 40761 100-240V 50/60 Hz, 450 VA MOD - Affinity 50 GMDN - 40761 100-240V 50/60 Hz, 450 VA MOD - Affinity 70 GMDN - 40761 100-240V 50/60 Hz, 450 VA

    FDA Enforcement
    Class II ·Terminated·Philips Ultrasound Inc·January 20, 2021

    Philips EPIQ and Affiniti Ultrasound Systems with software version 4.0: Models EPIQ 5G, EPIC 5C, EPIQ 5W, EPIQ 7G, EPIC 7C, EPIQ 7W, EPIZ CVx, Affiniti 30, Affiniti 50, and Affiniti 70. Product Usage: The intended use of the EPIQ, EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 and Affiniti 70 Diagnostic Ultrasound Systems is diagnostic ultrasound imaging and fluid flow analysis of the human body with the following Indications for Use: Abdominal, Cardiac Adult, Cardiac other (Fetal), Cardiac Pediatric, Cerebral Vascular, Cephalic (Adult), Cephalic (Neonatal), Fetal/Obstetric, Gynecological, Intraoperative (Vascular), Intraoperative (Cardiac), Musculoskeletal (Conventional), Musculoskeletal (Superficial), Other: Urology, Pediatric, Peripheral Vessel, Small Or Jan (Breast, Thyroid, Testicle), Transesophageal (Cardiac), Transrectal, Transvaginal. When integrated with Philips EchoNavigator, the systems can assist the interventionist and surgeon with image guidance during treatment of cardiovascular disease in which the procedure uses both live X-ray and live Echo Guidance.

    FDA Enforcement
    Class II ·Terminated·Philips Ultrasound Inc·August 14, 2019

    Turbo Elite Atherectomy Catheter. Models: 410-152, 410-154, 414-151, 414-159, 417-152, 417-156, 420-006, 420-159, 423-001, 423-135-01 The Laser Catheters are used in conjunction with the Spectranetics CVX-300¿ Excimer Laser System and are intended for use in patients with single or multivessel coronary artery disease, either as a stand-alone modality or in conjunction with Percutaneous Transluminal Coronary Balloon Angioplasty (PTCA), and who are acceptable candidates for coronary artery bypass graft (CABG) surgery.

    FDA Enforcement
    Class II ·Terminated·Spectranetics Corporation·December 7, 2016