16 results
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14ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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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
GE Healthcare, Compact Airway Modules E-CO, E-COV, E-COVX, E-CAiO, E-CAiOV and E-CAiOVX. The Datex-Ohmeda S/5MT Compact Airway Module, E-CAiOVX family is used for monitoring hospital patients respiration, ventilation, and gas exchange status.
FDA Enforcement
Class II
·Terminated·GE Healthcare, LLC·June 25, 2014
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
J-Plasma(R) Handpiece, Catalog Numbers: GS-018C, GS-270C, BVX-270B
FDA Enforcement
Class II
·Terminated·Bovie Medical Corporation·March 28, 2018
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
On-X Mitral Heart Valve with Conform-X Sewing Ring, Model: ONXMC-25/33
FDA Enforcement
Class II
·Ongoing·On-X Life Technologies, Inc.·May 20, 2026
Chord-X Chordal Sizer is designed to assist in determining the proper length of chordal replacement prostheses to repair the mitral valve and help the surgeon select a preconfigured prosthesis, or configure the correct size using straight suture material, during mitral valve repair.
FDA Enforcement
Class II
·Terminated·On-X Life Technologies, Inc.·February 1, 2017