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
Mar 25, 2011K102275THERMEDX 37-5 ELECTROCAUTERY PROBES, MODELS MPJ200, MPJ210, MPS220, MPN230, BPH240
Thermedx, LLC
GEI
Mar 16, 2011K103375PLUMEPEN INTEGRATED SMOKE EVACUATION PENCIL
Medtek Devices, Inc.
GEI
Feb 28, 2011K103840CURVED / STRAIGHT / MINI / HOOK SCISSOR TIP, DISSECTOR TIP, SURGICAL HANDLE
Flexbar Machine Corp.
GEI
Feb 16, 2011K103665CONMED R SABRE GENESIS TM ELECTROSURGICAL UNIT; CONED R SABRE GENESIS TM ELECTROSURGICAL UNIT (230V); CONMED HYFRESURG O
Conmed Corporation
GEI
Feb 7, 2011K102470LUGASURE CURVED, SMALL JAW, OPEN SEALER/DIVIDER
Covidien, Formerly Valleylab,
GEI
Feb 4, 2011K103707VECTEC DISPOSABLE MONOPOLAR CONNECTOR CABLE
Vectec
GEI
Jan 20, 2011K103017MEDERI THERAPEUTICS RF GENERATOR CONTROL MODULE
Mederi Therapeutics, Inc.
GEI
Jan 14, 2011K103032ESG-400 MODEL WB95051N, FOOTSWITCH DOUBLE PEDAL MODEL WB50402W, FOOTSWITCH SINGLE PEDAL MODEL WB50403W, P-CORD MODEL MAJ
Olympus Winter & Ibe GmbH
GEI
Jan 5, 2011K102698PELLEVE GLIDESAFE NON-ABLATIVE WRINKLE TREATMENT SYSTEM MODEL PELLEVE GLIDESAFE
Ellman Int'L, Inc.
GEI
Dec 17, 2010K102709PEAK PLASMABLADE PLUS TISSUE DISSECTION DEVICE
Peak Surgical, Inc.
GEI
Dec 16, 2010K102029PEAK PULSAR II GENERATOR MODEL PS100-102
Peak Surgical, Inc.
GEI
Dec 10, 2010K101520ENSEAL TISSUE SEALING DEVICES MODEL: NSEAL514H-535H, NSEAL514RH-535RH
Ethicon Endo-Surgery, Inc.
GEI
Nov 29, 2010K100586VENUS FREEZE SYSTEM
Venus Concept , Ltd., IL
GEI
Nov 24, 2010K101534CONMED ALTRUS THERMAL TISSUE FUSION SYSTEM
Conmedcorp
GEI
Nov 22, 2010K102114MEDRANGE ELECTROSURGICAL GENERATOR
Medrange Corporation
GEI
Nov 16, 2010K103282LAPAROSCOPIC DISSECTOR
Applied Medical Resources Corp.
GEI
Nov 3, 2010K102372OBS DISPOSABLE ELECTROSURGICAL PADS, MONOPOLAR, BIOPOLAR, MODELS GBS-DM, GBS-DB
Jiangmen City Xinhui Baisheng Medical Equipment CO, CN
GEI
Nov 1, 2010K102983VASCUCLEAR PRECISION BIPOLAR
Sorin Group USA, Inc.
GEI
Sep 7, 2010K102368NON-ABLATIVE WRINKLE TREATMENT HANDPIECE
Ellman Int'L, Inc.
GEI
Aug 25, 2010K100390SURGIMAX/ SURGIMAX PLUS
Elliquence, LLC
GEI
Aug 20, 2010K093622AEM MONITORING SYSTEM, MODELS EM2, EMR, ES4007, ES4107, ES9005 AND ES9015
Encision, Inc.
GEI
Aug 12, 2010K101967NON-ABLATIVE WRINKLE TREATENT HANDPIECE MODLE PELLEVE'
Ellman Int'L, Inc.
GEI
Aug 11, 2010K091310ABLATION INSTRUMENT, MODEL 1635; ABLATION MULTIPLEX CATHETER, MODEL 1682
Dfine, Inc.
GEI
Jul 23, 2010K100543MEDISSISS REPROCESSEDENT ABLATION WANDS (COBLATORS), MODEL#EIC8872-01
Medisiss
GEI
Jul 16, 2010K101108ERBE ESU MODEL VIO 100 C WITH ACCESSORIES
Erbe USA, Inc.
GEI
Jul 1, 2010K101711CERULEAU ELECTROSURGICAL PROBE
Nuortho Surgical, Inc.
GEI
Jul 1, 2010K100816PK SUPERPULSE SYSEM GENERATOR MODEL 744000
Gyrus Acmi, Inc.
GEI
Jun 22, 2010K093108STRYKER BIPOLAR FORCEPS
Stryker Leibinger GmbH & Co KG
GEI
Jun 21, 2010K101080NON STICK BIPOLAR FORCEPS MODEL 07/XXX, BIPOLAR FORCEPS MODEL 08/XXX, MONOPOLAR FORCEPS MODEL 09/XXX
Egon Faulhaber Surgical Instruments Pinzetten, DE
GEI
Jun 21, 2010K100333FIAB SPA, MODELS F7244, F7233, F7234, F7277
Fiab Spa, IT
GEI
Jun 18, 2010K101111HALO ABLATION CATHETER MODEL 90-9100, HALO90 ULTRA ABLATION CATHETER MODEL 90-9200
Barrx Medical, Inc.
GEI
Jun 18, 2010K100638VAPR VUE RADIOFREQUENCY SYSTEM ,MODEL 225024, VPR VUE WIRELESS FOOTSWITCH, MODEL 227214
Depuy Mitek, A Johnson & Johnson Company
GEI
Jun 17, 2010K100896GYRUS ACMI HALO PKS CUTTING FORCEPS
Gyrus Acmi, Inc.
GEI
Jun 14, 2010K094009HALT 2000GI ELECTROSURGICAL RF ABLATION SYSTEM MODEL HALT 2000GI
Halt Medical, Inc.
GEI
Jun 11, 2010K101274VASOVIEW HEMOPRO 2 ENDOSCOPIC VESSEL HARVESTING SYSTEM
Maquet Cardiovascular, LLC
GEI
Jun 9, 2010K100711SUCTION IRRIGATION ELECTRODES AND ADAPTERS
Encision, Inc.
GEI
May 21, 2010K100686CONMED MACROLYTE DISPERSIVE ELECTRODE
Conmed Corporation
GEI
May 14, 2010K100047SUREFIT DUAL DISPERSIVE ELECTRODE
Conmed Corporation
GEI
May 13, 2010K100353SPINEWAND SURGICAL DEVICE
Arthrocare Corp.
GEI
Apr 28, 2010K100258ELECTROSURGICAL PENCIL WITH ELECTRODE, WP200
Wickimed Supply Limited, CN
GEI
Apr 16, 2010K093511SORING MBC200/BCC140
Soring GmbH Medizintechnik, DE
GEI
Apr 13, 2010K093695PEAK PLASMABLADE 3.OS TISSUE DISSECTION DEVICE
Peak Surgical, Inc.
GEI
Apr 7, 2010K100224ESTECH COBRA BIPOLSR II
Endoscopic Technologies, Inc. D/B/A Estech
GEI
Apr 7, 2010K094041ALPHA ORTHOPAEDICS AT3 SYSTEM
Alpha Orthopaedics
GEI
Mar 30, 2010K100641INTRACEPT FLEXIBLE BI-POLAR RF PROBE AND EASY ACCESS INSTRUMENT SET, MODEL FG0018 (PROBE), FG0036 (INSTRUMENT SET)
Relievant Medsystems
GEI
Mar 18, 2010K092149BOSS COAGULATION DEVICE, MODEL BOSS1215, BOSS COAGULATION DEVICE, ANGLED ACCESS, MODEL BOSA1215
Bovie Medical
GEI
Mar 10, 2010K092383BOVIE ICON VS GENERAL PURPOSE RF GENERATOR, MODEL: VS300
Bovie Medical Corporation
GEI
Feb 26, 2010K093203CARDIOBLATE BIPOLAR RADIOFREQUENCY SURGICAL ABLATION SYSTEM, MODELS 60831, 60832, 60841
Medtronic, Inc.
GEI
Feb 23, 2010K093086ARTHROSTEER ABLATOR & COAGULATOR, MODELS: REF 1070 & 1080
Orthodynamix, LLC
GEI
Jan 21, 2010K093075ARAGON SURGICAL RF SYSTEM TELEO INSTRUMENT
Aragon Surgical, Inc.
GEI

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