Home › Device types › OCL
Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue
FDA product code OCL · Class 2 · General, Plastic Surgery
93
Registered devices
770
Adverse events
17
Recalls
54
510(k) clearances
Devices with this code
CARDIOBLATE® — MEDTRONIC, INC.CARDIOBLATE® — MEDTRONIC, INC.AtriCure Isolator Synergy EnCompass Clamp and Guide System — ATRICURE, INC.Numeris Tethered Coagulation System with VisiTrax® — ATRICURE, INC.nContact RF Generator — ATRICURE, INC.EPi-Sense Guided Coagulation System with VisiTrax — ATRICURE, INC.Cardioblate® — MEDTRONIC, INC.8mm Cryoprobe — VARIAN MEDICAL SYSTEMS, INC.Isolator Surgical Ablation System — ATRICURE, INC.NA — MEDTRONIC, INC.Isolator Surgical Ablation System — ATRICURE, INC.Isolator Surgical Ablation System — ATRICURE, INC.NA — MEDTRONIC, INC.nContact RF Generator — ATRICURE, INC.NA — MEDTRONIC, INC.CARDIOBLATE® — MEDTRONIC, INC.Cardioblate™ CryoFlex™ — MEDTRONIC, INC.Cardioblate® CryoFlex® — MEDTRONIC, INC.Fusion Ablation System — ATRICURE, INC.Cardioblate™ Gemini™-s — MEDTRONIC, INC.Cardioblate™ — MEDTRONIC, INC.AtriCure Isolator Synergy Clamp and Guide System — ATRICURE, INC.AtriCure Isolator Synergy Clamp and Guide System — ATRICURE, INC.Cardioblate® CryoFlex® — MEDTRONIC, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-04-20 | Medtronic Perfusion Systems | Firm detected an increase in complaints related to fractured jaw tips of the Cardioblate Gemini-s. |
| 2021-09-27 | Medtronic Perfusion Systems | There is potential for intermittent electrical connectivity between the console and probe. |
| 2020-10-12 | MEDTRONIC ATS MEDICAL, INC. | There is a potential defect in the seals of the sterile barrier pouch used to package the CryoFlex disposables devices |
| 2020-10-12 | MEDTRONIC ATS MEDICAL, INC. | There is a potential defect in the seals of the sterile barrier pouch used to package the CryoFlex disposables devices |
| 2020-10-12 | MEDTRONIC ATS MEDICAL, INC. | There is a potential defect in the seals of the sterile barrier pouch used to package the CryoFlex disposables devices |
| 2020-10-12 | MEDTRONIC ATS MEDICAL, INC. | There is a potential defect in the seals of the sterile barrier pouch used to package the CryoFlex disposables devices |
| 2019-05-29 | AtriCure, Inc. | The sterile package seal for the Epi-Sense Guided Coagulation System may be compromised, and has a worst-case reasonable harm of infection if used. |
| 2019-01-22 | AtriCure, Inc. | There is a potential for patients undergoing ablation to experience an elevated risk for TE; during stand-alone off-pump procedures where cardio pulmonary bypas |
| 2019-01-22 | AtriCure, Inc. | There is a potential for patients undergoing ablation to experience an elevated risk for TE; during stand-alone off-pump procedures where cardio pulmonary bypas |
| 2019-01-22 | AtriCure, Inc. | There is a potential for patients undergoing ablation to experience an elevated risk for TE; during stand-alone off-pump procedures where cardio pulmonary bypas |
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