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
Jan 15, 2010K093855HALO 360 & SIZING BALLOON, MODEL 3441C
Barrx Medical, Incorporated
GEI
Jan 15, 2010K091674ARTHROCARE COBLATOR IQ SYSTEM
Arthrocare Corp.
GEI
Jan 15, 2010K091259ETHICON ENDO-SURGERY FLEXIBLE BIPOLAR HEMOSTASIS FORCEPS
Ethicon Endo-Surgery, Inc.
GEI
Jan 8, 2010K093008HALO ABLATION CATHETER, MODEL 90-9100
Barrx Medical, Incorporated
GEI
Jan 8, 2010K090025MATRIX RF APPLICATOR
Syneron Medical, Ltd., IL
GEI
Dec 22, 2009K093025BOVIE RESISTICK II COATED ELECTROSURGICAL ELECTRODES
Bovie Medical Corporation
GEI
Dec 4, 2009K093165ARTHROCARE SYSTEM 15000 CONTROLLER, ARTHROWANDS
Arthrocare Corp.
GEI
Dec 4, 2009K091672DISPOSABLE GROUNDING PAD SERIES AND ELECTRODE SERIES
Shuyou Electric Medical Science Co., Ltd., CN
GEI
Dec 1, 2009K092634OBS DISPOSABLE ELECTROSURGICAL PENCILS, MODELS: OBS-DB, OBS-DR, OBS-DF
Jiangmen City Xinhui Baisheng Medical Equipment CO, CN
GEI
Nov 27, 2009K091824ETHICON ENDO-SURGERY ROTATING ENDOSCOPIC SCISSORS, MODEL IN2507
Ethicon Endo-Surgery, Inc.
GEI
Nov 25, 2009K092732PROPENCIL ESU PENCIL
Bio Protech, Inc., KR
GEI
Nov 25, 2009K092191EXILIS, MODEL 5000
Btl Industries, Ltd.
GEI
Nov 24, 2009K092761PROPLATE, MODELS 9641C, 9641F, P9641C, P9641F, 9642C, 9642F AND P9642C
Bio Protech, Inc.
GEI
Nov 20, 2009K083754MINI LAP ELECTROCAUTERY INSTRUMENTS
Mini Lap Technologies, Inc.
GEI
Nov 10, 2009K092487HALOFLEX ENERGY GENERATOR, MODELS 1190A-115A AND 1190A-230A
Barrx Medical, Incorporated
GEI
Nov 6, 2009K092009MODIFICATION TO: LEVEEN SUPERSLIM NEEDLE ELECTRODES, MODELS M001262260, M001262270, M001262280, M001262290
Boston Scientific Corporation
GEI
Oct 29, 2009K091290ETHICON ENDO-SURGERY ROTATING HOOK KNIFE, MODEL IN2508
Ethicon Endo-Surgery, Inc.
GEI
Oct 28, 2009K082584GIVEN ELECTROSURGICAL NEEDLE
Tripps Court Enterprises, Inc.
GEI
Oct 16, 2009K092879LIGASURE 5MM BLUNT TIP LAPAROSCOPIC SEALER-DIVIDER
Valleylab
GEI
Oct 9, 2009K091440LAPAROSCOPIC RESECTION DEVICE, MODEL SR326L
Bovie Medical
GEI
Sep 28, 2009K091228SPINEWAND SURGICAL DEVICE
Arthrocare Corp.
GEI
Sep 11, 2009K091223VALLEYLAB SUCTION COAGULATOR, MODEL E3305
Covidien LP
GEI
Sep 1, 2009K082391PRIMAEVA MEDICAL RENESIS SYSTEM
Primaeva Medical, Inc.
GEI
Aug 28, 2009K091733VASOVIEW 6 PRO ENDOSCOPIC VESSEL HARVESTING SYSTEM, MODEL VH-2500
Maquet Cardiovascular, LLC
GEI
Aug 28, 2009K090309LAGIS ENDOSCOPIC INSTRUMENTS
Lagis Enterprises Co, Ltd.
GEI
Aug 26, 2009K083608ERBE HYBRID KNIFE
Erbe USA, Inc.
GEI
Aug 17, 2009K091074AEM DISPOSABLE ELECTRODES,MODEL ESO300 SERIES
Encision, Inc.
GEI
Aug 13, 2009K080844G3 GENERATOR AND ACCESSORIES-DISSECTOR PLASMA KNIFE
Gyrus Acmi, Inc.
GEI
Aug 7, 2009K090586BOVIE ICON GS ELECTROSURGICAL GENERATOR (GS100), HANDPIECE (GS-OP-R), REUSABLE HANDPIECE CABLE (GS807-RC)
Bovie Medical
GEI
Jul 24, 2009K083461IMAGINE TC SKIN THERAPY SYSTEM
Endymion Medical, Ltd., IL
GEI
Jun 26, 2009K090580THERMAGE THERMACOOL NXT SYSTEM AND ACCESSORIES
Solta Medical, Inc.
GEI
Jun 23, 2009K090393ARTHROCARE SYSTEM 15000 CONTOLLER, MODEL 72202149, ARTHROCARE ARTHROWANDS, MODEL 72202139,72202141, 72202143, 72202144
Arthrocare Corp.
GEI
Jun 23, 2009K083895CODMAN ISOCOOL BIPOLAR FORCEPS
Codman & Shurtleff, Inc.
GEI
Jun 18, 2009K090306ARAGON SURGICAL RF SYSTEM L2 INSTRUMENT
Aragon Surgical, Inc.
GEI
Jun 12, 2009K082505KLS MARTIN ELECTROSURGICAL INSTRUMENTS
Kl Martin L.P.
GEI
Jun 5, 2009K083415PEAK PLASMABLADE TNA TONSIL AND ADENOID TISSUE DISSECTION DEVICE
Peak Surgical, Inc.
GEI
May 7, 2009K082834ELLMAN INTERNATIONAL NON-ABLATIVE TECHNIQUE FOR SURGITRON IEC
Ellman Int'L, Inc.
GEI
May 1, 2009K091107MODEL P8400 HEMOSTATIX THERMAL SCALPEL SYSTEM
Hemostatix Medical Technologies, LLC
GEI
Apr 17, 2009K083590ISKRA MEDICAL GREEN IRF PRESTIGE
Iskra Medical, D.O.O., SI
GEI
Feb 25, 2009K083281EL LIGHTWAVE SUCTION ABLATOR, MODEL EL-2000-S, LIGHTWAVE SUCTION ABLATOR, MODEL IA-2000-S, LIGHTWAVE ABLATOR, MODEL IA-
Linvatec Corp.
GEI
Feb 10, 2009K083737HALO ABLATION CATHETER
Barrx Medical, Incorporated
GEI
Feb 6, 2009K081398ADVANCED MEDICAL INNOVATIONS DISPOSABLE TROCARS AND LAPAROSCOPIC ACCESSORIES
Advanced Medical Innovations, Inc.
GEI
Feb 2, 2009K083711MODIFICATION TO: HALO COAGULATION CATHETER, MODELS 32041-18, 32041-20, 32041-22, 32041-25, 32041-28, 32041-31, 32041-34
Barrx Medical, Incorporated
GEI
Jan 28, 2009K083528SMITH & NEPHEW BIPOLAR ADAPTER CABLE, MODEL 72200022
Smith & Nephew, Inc.
GEI
Jan 22, 2009K083856INTRACEPT FLEXIBLE BI-POLAR RF PROBE AND CURVED INSTRUMENT SET, MODELS: FG0018, FG0026
Relievant Medsystems, Inc.
GEI
Jan 15, 2009K082955ETHICON ENDO-SURGERY ARTICULATING HOOK KNIFE, MODEL IN4505
Ethicon Endo-Surgery, Inc.
GEI
Jan 12, 2009K083162STINGRAY ELECTROSURGICAL FORCEPS
Stingray Surgical Products, Inc.
GEI
Dec 31, 2008K083452ERBE MODEL VIO 300 D WITH ACCESSORIES
Erbe USA, Inc.
GEI
Dec 19, 2008K0826433.5 MM SIDE EFFECT ELECTRODE WITH INTEGRATED HANDPIECE, MODEL 227301, 3.5 MM ANGLED SIDE EFFECT ELECTRODE WITH INTEGRATE
Depuy Mitek, A Johnson & Johnson Company
GEI
Dec 18, 2008K082956ALPHA ORTHOPAEDICS AT2 SYSTEM
Alpha Orthopaedics
GEI

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