ClearanceBrief
Panels › General, Plastic Surgery › Product code GEI · Class 2

Electrosurgical, Cutting & Coagulation & Accessories

Regulation 878.4400

47510(k)s in 12 months (2,321 all time)
18recalls in 12 months (644 all time)
601recalls that name a 510(k)
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Top companies in GEI

Company510(k)sRecalls
ArthroCare Corporation865
Conmed Corporation2553
Valleylab690
Megadyne Medical Products, Inc.3231
Covidien4114
Carefusion 2200, Inc.245
Stryker935
Conmedcorp430
Gyrus Acmi, Inc.2120
Bovie Medical2115
Decided510(k)Device and applicantCode
Aug 22, 2016K162074Werewolf RF20000 Controller, FLOW 50 Wand
ArthroCare Corporation
GEI
Aug 12, 2016K161661Thermi RF Accessories
Thermi
GEI
Aug 12, 2016K160331LigaSure Curved Jaw, Open Sealer/Divider Electrode, LigaSure Curved Jaw Open Reusable Clamp
Covidien, CN
GEI
Aug 11, 2016K162075NICO TRIOwand
Nico Corporation
GEI
Jul 29, 2016K161558Bovie 3.3mm Disposable Bipolar Ablator 90°, Aspirating and Non-Aspirating, Bovie 2.4mm Disposable Bipolar Ablator 55°, N
Bovie Medical Corporation
GEI
Jul 21, 2016K153727INTRAcel Premium Fractional RF Micro Needle (FRM) System
Jeisys Medical, Inc., KR
GEI
Jul 20, 2016K152731XP1100 RF
BTL Industries, Inc.
GEI
Jul 11, 2016K153055ACE Electrosurgical Resection and Vaporization Electrodes Series
Ace Medical Devices Pvt. , Ltd., IN
GEI
Jul 8, 2016K152703PlasmaBlade TnA Tonsil and Adenoid Dissection Device
Medtronic Advanced Energy
GEI
Jul 7, 2016K161305Habib EUS RFA
Emcision , Ltd., GB
GEI
Jul 6, 2016K153017Voyant Fine Fusion
Applied Medical Resources
GEI
Jun 23, 2016K160602JustRight Surgical Vessel Sealing System
Justright Surgical
GEI
Jun 20, 2016K161134Bovie Bantam/PRO Electrosurgical Generator, Bovie DERM 941 Electrosurgical Generator, Bovie DERM 942 Electrosurgical Gen
Bovie Medical Corporation
GEI
Jun 15, 2016K160539BiZact Open Sealer/Divider
Covidien
GEI
Jun 2, 2016K151229ABC D-FLEX PROBE
Conmed Corporation
GEI
Jun 1, 2016K153288Voyant Open Fusion Device
Applied Medical Resources
GEI
May 19, 2016K160290Valleylab REM Polyhesive Infant Patient Return Electrode
Covidien, LLC
GEI
May 6, 2016K160053Monopolar single-use HF cable
Olympus Winter & Ibe GmbH, DE
GEI
May 5, 2016K150364ERBE ESU Model VIO dV with Accessories
Erbe Elektromedizin GmbH, DE
GEI
May 4, 2016K160639Electrosurgical Generator ESG-200
Olympus Winter & Ibe GmbH, DE
GEI
May 3, 2016K160050SERFAS 90-S Electrosurgical Probe
Stryker Corporation
GEI
Apr 28, 2016K160128Endopath Electrosurgery Probe Plus II
Ethicon Endo-Surgery, LLC
GEI
Apr 21, 2016K160206VirtuoSaph Plus Endoscopic Vessel Harvesting System
Terumo Cardiovascular Systems Corporation
GEI
Apr 21, 2016K152059Disposable General Electrode
Modern Medical Equipment Manufacturing Limited, TW
GEI
Apr 19, 2016K153194VASOVIEW HemoPro Endoscopic Vessel Harvesting System
Maquet Cardiovascular, LLC
GEI
Apr 13, 2016K160693Neptune E-SEP Smoke Evacuation Pencil
Stryker Corporation
GEI
Apr 8, 2016K153063PERCUVANCE PERCUTANEOUS SURGICAL SYSTEM
Teleflexmedical, Inc.
GEI
Apr 5, 2016K160360Barrx FLEX RFA Energy Generator
Covidien, LLC
GEI
Apr 5, 2016K160160Non-Telescopic PenEvac
I.C Medical, Inc.
GEI
Mar 23, 2016K152933Vesalius
Telea Electronic Engineering Srl, IT
GEI
Mar 18, 2016K150915SPINAUT-P
Imedicom Co., Ltd., KR
GEI
Mar 7, 2016K160041Cobbra RF Tissue Dissector
Elliquence, LLC
GEI
Feb 26, 2016K151743THUNDERBEAT Open Fine Jaw
Olympus Medical Systems Corp., JP
GEI
Feb 19, 2016K151793InMode RF System
Inmode MD , Ltd., IL
GEI
Feb 19, 2016K151480Epix Electrosurgical Probe with Smoke Evacuation
Applied Medical Resources
GEI
Feb 18, 2016K152702ENT BIOTECH SOLUTIONS TISSUE REMOVAL DEVICE (ELASSO)
Ent Biotech Solutions
GEI
Jan 22, 2016K153679Stryker Neptune E-SEP Smoke Evacuation Pencil
Stryker Corporation
GEI
Jan 15, 2016K153675Paragon T2 Wand with Integrated Cable
ArthroCare Corporation
GEI
Jan 15, 2016K152777Bovie Disposable Bipolar Ablator
Bovie Medical Corporation
GEI
Jan 5, 2016K153265New Deantronics Disposable Laparoscopic Electrodes, non-coated, and coated
New Deantronics Taiwan , Ltd., TW
GEI
Jan 4, 2016K151273InMode FRF Applicator
Inmode MD , Ltd., IL
GEI
Dec 29, 2015K152860HELIXAR ELECTROSURGICAL GENERATOR WITH ARGON BEAM COAGULATION, HELIXAR MOBILE PEDESTAL
Conmed Corporation
GEI
Dec 18, 2015K153499EDGE Arthroscopic Energy System, Arthroscopic Energy System Probes, Arthroscopic Energy System Wireless Footswitch, Arth
Conmed Corporation
GEI
Dec 17, 2015K152219PK AIM
Gyrus Acmi, Inc.
GEI
Nov 24, 2015K152057OsteoCool V-3 RF Ablation System
Baylis Medical Company, Inc., CA
GEI
Nov 19, 2015K150637Aerin Medical Wand Model FG011
Aerin Medical, Inc.
GEI
Nov 2, 2015K152570Bovie J-Plasma Precise 360 Handpiece
Bovie Medical Corporation
GEI
Oct 30, 2015K142410Elliquence Electrodes
Elliquence, LLC
GEI
Oct 27, 2015K143306ERBE WaterJet Model ERBEJET® 2 System with HybridAPC Probe
Erbe USA, Inc.
GEI
Oct 23, 2015K143235RF20000a Controller, FLOW 50 Wand
ArthroCare Corporation
GEI

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