GEI
InMode RF System
- Advisory panel
- General, Plastic Surgery
- Total cleared
- 2,296
Adverse events under product code GEI
product code GEI- Death
- 133
- Injury
- 7,585
- Malfunction
- 35,808
- Other
- 44
- Total
- 43,570
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code GEI
1–100 of 2,296- K253777 — Ascblue (8010)
- K253917 — ARION ARC System
- K260466 — Multifunctional Operational Dissectors (Electrosurgical Pencils);Multifunctional Operational Dissectors (Disposable Electrode)
- K260397 — SYNERJET PRO (SP-1002); InPhiuse (SP-1002); WOWJET (SP-1002)
- K253405 — Prana System
- K254122 — FLOW FLEXTEND Wand (72290039)
- K260255 — AVENTIX PFX System (PFX01); NOVOCLEAR Device (CLR001)
- K253680 — LYNX COBLATION Laryngeal Wand (72290254)
- K253750 — BTL-785NEH
- K252487 — POWERSEAL Open Extended Jaw Sealer and Divider, Double-Action (PS-0021EJDA)
- K260287 — SP Electrocautery Device (SP20)
- K251813 — CURIS II RF Generator (REF 360100-05)
- K251836 — Dermatrix Duo
- K254290 — ZenTite (Unicorn+); ZenTite (Unicorn+I); ZenTite (Unicorn+II); ZenTite (Unicorn+III)
- K251435 — InbellaIgnite RF System
- K254220 — Reusable 3 Button Fingerswitch Wand
- K251254 — Ignite RF System
- K251996 — ENTire IRE System
- K251988 — Boston iFace (Boston iFace)
- K253915 — MOVIVA® Hybrid Ablation Probe
- K252704 — F Care RF System (00MEDRF4000US, 05RAFAELOPROBE, 05SPHERAPROBE, 06OUTPUTKAB, 06Pedal1St)
- K251566 — TS-RF Generator (STS10)
- K252845 — Venus Nova (FP-2001)
- K252740 — Voyant® Open Fusion Device (EB240/Open Fusion)
- K252412 — Voyant® Electrosurgical Generator (EA030/Electrosurgical Generator)
- K250275 — PrecisePath Radiofrequency Puncture Generator and PrecisePath Footswitch
- K250126 — ArtiSeal Vessel Sealing System - ArtiSeal Instruments (AS01M)
- K250852 — Coolfase
- K252367 — InbellaMulti System
- K250688 — Cedar Endovenous Radiofrequency Catheter (ERA-C70-US); Cedar Endovenous Radiofrequency Catheter (ERA-C30-US); Endovenous Radiofrequency Generator (ERA-G5-US)
- K252150 — Ultrasonic Bipolar Generator (USG-410); Reuseable Cordless Transducer (TD-410); THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 45cm (TB2-0545FC); THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 35cm (TB2-0535FC); THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 25cm (TB2-0525FC); THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 20cm (TB2-0520FC)
- K251899 — E Blator
- K251334 — NEW DOUBLO 2.0
- K252043 — Bipolar applicator CelonProBreath (WB990310); Bipolar applicator CelonProSleep plus (WB990311); Bipolar applicator CelonProBreath (WB990210); Bipolar applicator CelonProSleep plus (WB990211)
- K252576 — Legend X Platform
- K250483 — PhotonBlade 3; PhotonBlade 3 Smoke Evacuation
- K250217 — AGNES Ultra
- K251108 — Erbe ESU Model VIO® 3n with Accessories
- K243713 — Single Use RF Surgical Electrode (Needle Type) (AN-B, AN-C, AN-E, AN-I, AN-S, AN-W3A, AN-F3A, AN-IL, AN-SL, AN-W3B, AN-F1A, AN-F3B, AN-B3A)
- K252316 — Venclose digiRF Generator (VCRFG1); Venclose EVSRF Catheter (VC10A256F60, VC10A256F100)
- K252083 — HOTWIRE System RF Generator and Footswitch (optional accessory)
- K251327 — XERF
- K252211 — Duoblade Plus SE (DB1EP, DB1EP-T, DB1EP-H, DB1EP-TH); Duoblade Prime (DB1P, DB1P-T, DB1P-H, DB1P-TH)
- K252215 — InbellaMAX System
- K250065 — DENSITY; DENZA; DENSITY Noir
- K243120 — HybridAPC probe
- K251235 — Electrosurgical Pads
- K242996 — EndyMed PRO MAX
- K242907 — DELPHI System
- K250657 — gi2000 Electrosurgical Generator
- K251238 — Vasoview Hemopro 3 Endoscopic Vessel Harvesting System (VH-6000); Vasoview Hemopro 3 Endoscopic Vessel Harvesting System with Vasoshield (VH-6001); Vasoview Hemopro 3 Power Supply (VH-6010)
- K250048 — NEUROMARK System (NMK00301)
- K243176 — BLESSING System
- K240857 — Youmagic FLM System (YM5-U1)
- K250400 — Vigeon Laparoscopic Universal Smoke Evacuator (VG003)
- K242469 — RFMagik Lite
- K242773 — Electro Lube NXT
- K250327 — OptaBlate Radiofrequency (RF) Generator System
- K243451 — FiAPC plus probes
- K242241 — Sunny
- K243918 — Vasoview Hemopro 3 Power Supply
- K241832 — Unicorn+ RF System (Unicorn+); Unicorn+ RF System (Unicorn+ I); Unicorn+ RF System (Unicorn+ II); Unicorn+ RF System (Unicorn+ III)
- K250200 — InbellaBody System
- K242983 — CROMA Electrosurgical Generator (PRD-EMR-050)
- K250068 — Venclose digiRF Generator (VCRFG1)
- K240311 — JETT Medical II
- K243139 — Reverso Pro System
- K243929 — Oligio X
- K243067 — The ETHICON Total Energy System
- K233118 — DUET-V (Model: ESK-3261DV)
- K243737 — Inbella RF System
- K243097 — RM STAR EX with RMS Needle
- K240975 — Electrosurgical Generator (ES-100); Electrosurgical Generator (ES-300)
- K242688 — Finiff System
- K242370 — Medline Microdissection Needle (4cm) (140936 (ESE104A)); Medline Microdissection Needle (3cm) (140937 (ESE103A))
- K240758 — Radiofrequency Generator System, Cura RF Electrode
- K231216 — POTENZA
- K242630 — Aerin Console
- K240897 — Cellinew
- K241157 — Secret MAX Multi-platform RF System
- K241138 — ArtiSeal Vessel Sealing System-ArtiSeal Instruments; ArtiSeal Vessel Sealing System-ArtiSeal Generator
- K241099 — Plasonic (Plasonic)
- K242286 — Superflow Prime Treatment System (ASP-1M)
- K231287 — POTENZA
- K243217 — Legend X Desktop System
- K242266 — PhotonBlade 3; PhotonBlade 3 Smoke Evacuation
- K241535 — Vybe RF II
- K242204 — Disposable Neutral Electrodes (GP201B-A, GP202B-A, GP202B-P, GP202B-I, GP202M-A, GP202M-P, GP202M-I, GP202B-AC, GP202B-PC, GP202B-IC, GP202M-AC, GP202M-PC, GP202M-IC, GP203M-A, GP203B-A, GP203M-AC, GP203B-AC, GP203M-P, GP203B-P, GP203M-PC, GP203B-PC, GP203M-I, GP203B-I, GP203M-IC, GP203B-IC)
- K242044 — FiAPC plus probes
- K240782 — CellFX Percutaneous Electrode System (SYS3000); CellFX Percutaneous Electrode, 13G (CPE013); CellFX Percutaneous Electrode, 18G (CPE018)
- K240932 — HybridTherm System
- K241635 — da Vinci E-200 Electrosurgical Generator
- K241621 — Da Vinci Monopolar and Bipolar Adapters (378896)
- K240780 — InMode RF System
- K233644 — Megadyne Patient Return Electrode Pad - Universal Dual (model 0846), Megadyne Patient Return Electrode Pad - Universal Plus (model 0847), Megadyne Patient Return Electrode Pad - Universal Dual Plus (model 0848)
- K241085 — Valleylab FT10 Energy Platform Software Version 5.0 (VLFT10GEN VLFT10FXGEN VLFT10LSGEN)
- K241022 — Sterile single use tip cleaner (WK800-S10 , WK800-S20)
- K240070 — Profound Matrix
- K240572 — Valleylab SM Smoke Management Pencil with Edge Blade Electrode, 10 (3m) (VSMP10); Valleylab SM Smoke Management Pencil with Edge Blade Electrode, 15 (4.6m) (VSMP15); Valleylab SM Smoke Management Pencil with Edge Blade Electrode, 10 (3m), Non-Sterile Bulk (VSMP10NSB); Valleylab SM Smoke Management Extended Nozzle (for use with 4 (100mm) electrode) (VSMEN4); Valleylab SM Smoke Management Extended Nozzle (for use with 6.5 (165mm) electrode) (VSMEN6)
- K233123 — SILKRO
Data sourced from openFDA. This site is unofficial and independent of the FDA.