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GEI

2,312 FDA 510(k) clearances · Product code

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RecordFirmDate
PEAK PLASMABLADE PLUS TISSUE DISSECTION DEVICE (K102709)Peak Surgical, Inc.2010-12-17
PEAK PULSAR II GENERATOR MODEL PS100-102 (K102029)Peak Surgical, Inc.2010-12-16
ENSEAL TISSUE SEALING DEVICES MODEL: NSEAL514H-535H, NSEAL514RH-535RH (K101520)Ethicon Endo-Surgery, Inc.2010-12-10
VENUS FREEZE SYSTEM (K100586)Venus Concept , Ltd.2010-11-29
CONMED ALTRUS THERMAL TISSUE FUSION SYSTEM (K101534)Conmedcorp2010-11-24
MEDRANGE ELECTROSURGICAL GENERATOR (K102114)Medrange Corporation2010-11-22
LAPAROSCOPIC DISSECTOR (K103282)Applied Medical Resources Corp.2010-11-16
OBS DISPOSABLE ELECTROSURGICAL PADS, MONOPOLAR, BIOPOLAR, MODELS GBS-DM, GBS-DB (K102372)Jiangmen City Xinhui Baisheng Medical Equipment CO2010-11-03
VASCUCLEAR PRECISION BIPOLAR (K102983)Sorin Group USA, Inc.2010-11-01
NON-ABLATIVE WRINKLE TREATMENT HANDPIECE (K102368)Ellman Int'L, Inc.2010-09-07
SURGIMAX/ SURGIMAX PLUS (K100390)Elliquence, LLC2010-08-25
AEM MONITORING SYSTEM, MODELS EM2, EMR, ES4007, ES4107, ES9005 AND ES9015 (K093622)Encision, Inc.2010-08-20
NON-ABLATIVE WRINKLE TREATENT HANDPIECE MODLE PELLEVE' (K101967)Ellman Int'L, Inc.2010-08-12
ABLATION INSTRUMENT, MODEL 1635; ABLATION MULTIPLEX CATHETER, MODEL 1682 (K091310)Dfine, Inc.2010-08-11
MEDISSISS REPROCESSEDENT ABLATION WANDS (COBLATORS), MODEL#EIC8872-01 (K100543)Medisiss2010-07-23
ERBE ESU MODEL VIO 100 C WITH ACCESSORIES (K101108)Erbe USA, Inc.2010-07-16
PK SUPERPULSE SYSEM GENERATOR MODEL 744000 (K100816)Gyrus Acmi, Inc.2010-07-01
CERULEAU ELECTROSURGICAL PROBE (K101711)Nuortho Surgical, Inc.2010-07-01
STRYKER BIPOLAR FORCEPS (K093108)Stryker Leibinger GmbH & Co KG2010-06-22
NON STICK BIPOLAR FORCEPS MODEL 07/XXX, BIPOLAR FORCEPS MODEL 08/XXX, MONOPOLAR FORCEPS MODEL 09/XXX (K101080)Egon Faulhaber Surgical Instruments Pinzetten2010-06-21
FIAB SPA, MODELS F7244, F7233, F7234, F7277 (K100333)Fiab Spa2010-06-21
VAPR VUE RADIOFREQUENCY SYSTEM ,MODEL 225024, VPR VUE WIRELESS FOOTSWITCH, MODEL 227214 (K100638)Depuy Mitek, A Johnson & Johnson Company2010-06-18
HALO ABLATION CATHETER MODEL 90-9100, HALO90 ULTRA ABLATION CATHETER MODEL 90-9200 (K101111)Barrx Medical, Inc.2010-06-18
GYRUS ACMI HALO PKS CUTTING FORCEPS (K100896)Gyrus Acmi, Inc.2010-06-17
HALT 2000GI ELECTROSURGICAL RF ABLATION SYSTEM MODEL HALT 2000GI (K094009)Halt Medical, Inc.2010-06-14
VASOVIEW HEMOPRO 2 ENDOSCOPIC VESSEL HARVESTING SYSTEM (K101274)Maquet Cardiovascular, LLC2010-06-11
SUCTION IRRIGATION ELECTRODES AND ADAPTERS (K100711)Encision, Inc.2010-06-09
CONMED MACROLYTE DISPERSIVE ELECTRODE (K100686)Conmed Corporation2010-05-21
SUREFIT DUAL DISPERSIVE ELECTRODE (K100047)Conmed Corporation2010-05-14
SPINEWAND SURGICAL DEVICE (K100353)Arthrocare Corp.2010-05-13
ELECTROSURGICAL PENCIL WITH ELECTRODE, WP200 (K100258)Wickimed Supply Limited2010-04-28
SORING MBC200/BCC140 (K093511)Soring GmbH Medizintechnik2010-04-16
PEAK PLASMABLADE 3.OS TISSUE DISSECTION DEVICE (K093695)Peak Surgical, Inc.2010-04-13
ALPHA ORTHOPAEDICS AT3 SYSTEM (K094041)Alpha Orthopaedics2010-04-07
ESTECH COBRA BIPOLSR II (K100224)Endoscopic Technologies, Inc. D/B/A Estech2010-04-07
INTRACEPT FLEXIBLE BI-POLAR RF PROBE AND EASY ACCESS INSTRUMENT SET, MODEL FG0018 (PROBE), FG0036 (INSTRUMENT SET) (K100641)Relievant Medsystems2010-03-30
BOSS COAGULATION DEVICE, MODEL BOSS1215, BOSS COAGULATION DEVICE, ANGLED ACCESS, MODEL BOSA1215 (K092149)Bovie Medical2010-03-18
BOVIE ICON VS GENERAL PURPOSE RF GENERATOR, MODEL: VS300 (K092383)Bovie Medical Corporation2010-03-10
CARDIOBLATE BIPOLAR RADIOFREQUENCY SURGICAL ABLATION SYSTEM, MODELS 60831, 60832, 60841 (K093203)Medtronic, Inc.2010-02-26
ARTHROSTEER ABLATOR & COAGULATOR, MODELS: REF 1070 & 1080 (K093086)Orthodynamix, LLC2010-02-23
ARAGON SURGICAL RF SYSTEM TELEO INSTRUMENT (K093075)Aragon Surgical, Inc.2010-01-21
ETHICON ENDO-SURGERY FLEXIBLE BIPOLAR HEMOSTASIS FORCEPS (K091259)Ethicon Endo-Surgery, Inc.2010-01-15
HALO 360 & SIZING BALLOON, MODEL 3441C (K093855)Barrx Medical, Incorporated2010-01-15
ARTHROCARE COBLATOR IQ SYSTEM (K091674)Arthrocare Corp.2010-01-15
MATRIX RF APPLICATOR (K090025)Syneron Medical, Ltd.2010-01-08
HALO ABLATION CATHETER, MODEL 90-9100 (K093008)Barrx Medical, Incorporated2010-01-08
BOVIE RESISTICK II COATED ELECTROSURGICAL ELECTRODES (K093025)Bovie Medical Corporation2009-12-22
ARTHROCARE SYSTEM 15000 CONTROLLER, ARTHROWANDS (K093165)Arthrocare Corp.2009-12-04
DISPOSABLE GROUNDING PAD SERIES AND ELECTRODE SERIES (K091672)Shuyou Electric Medical Science Co., Ltd.2009-12-04
OBS DISPOSABLE ELECTROSURGICAL PENCILS, MODELS: OBS-DB, OBS-DR, OBS-DF (K092634)Jiangmen City Xinhui Baisheng Medical Equipment CO2009-12-01
ETHICON ENDO-SURGERY ROTATING ENDOSCOPIC SCISSORS, MODEL IN2507 (K091824)Ethicon Endo-Surgery, Inc.2009-11-27
PROPENCIL ESU PENCIL (K092732)Bio Protech, Inc.2009-11-25
EXILIS, MODEL 5000 (K092191)Btl Industries, Ltd.2009-11-25
PROPLATE, MODELS 9641C, 9641F, P9641C, P9641F, 9642C, 9642F AND P9642C (K092761)Bio Protech, Inc.2009-11-24
MINI LAP ELECTROCAUTERY INSTRUMENTS (K083754)Mini Lap Technologies, Inc.2009-11-20
HALOFLEX ENERGY GENERATOR, MODELS 1190A-115A AND 1190A-230A (K092487)Barrx Medical, Incorporated2009-11-10
MODIFICATION TO: LEVEEN SUPERSLIM NEEDLE ELECTRODES, MODELS M001262260, M001262270, M001262280, M001262290 (K092009)Boston Scientific Corporation2009-11-06
ETHICON ENDO-SURGERY ROTATING HOOK KNIFE, MODEL IN2508 (K091290)Ethicon Endo-Surgery, Inc.2009-10-29
GIVEN ELECTROSURGICAL NEEDLE (K082584)Tripps Court Enterprises, Inc.2009-10-28
LIGASURE 5MM BLUNT TIP LAPAROSCOPIC SEALER-DIVIDER (K092879)Valleylab2009-10-16
LAPAROSCOPIC RESECTION DEVICE, MODEL SR326L (K091440)Bovie Medical2009-10-09
SPINEWAND SURGICAL DEVICE (K091228)Arthrocare Corp.2009-09-28
VALLEYLAB SUCTION COAGULATOR, MODEL E3305 (K091223)Covidien LP2009-09-11
PRIMAEVA MEDICAL RENESIS SYSTEM (K082391)Primaeva Medical, Inc.2009-09-01
VASOVIEW 6 PRO ENDOSCOPIC VESSEL HARVESTING SYSTEM, MODEL VH-2500 (K091733)Maquet Cardiovascular, LLC2009-08-28
LAGIS ENDOSCOPIC INSTRUMENTS (K090309)Lagis Enterprises Co, Ltd.2009-08-28
ERBE HYBRID KNIFE (K083608)Erbe USA, Inc.2009-08-26
AEM DISPOSABLE ELECTRODES,MODEL ESO300 SERIES (K091074)Encision, Inc.2009-08-17
G3 GENERATOR AND ACCESSORIES-DISSECTOR PLASMA KNIFE (K080844)Gyrus Acmi, Inc.2009-08-13
BOVIE ICON GS ELECTROSURGICAL GENERATOR (GS100), HANDPIECE (GS-OP-R), REUSABLE HANDPIECE CABLE (GS807-RC) (K090586)Bovie Medical2009-08-07
IMAGINE TC SKIN THERAPY SYSTEM (K083461)Endymion Medical, Ltd.2009-07-24
THERMAGE THERMACOOL NXT SYSTEM AND ACCESSORIES (K090580)Solta Medical, Inc.2009-06-26
CODMAN ISOCOOL BIPOLAR FORCEPS (K083895)Codman & Shurtleff, Inc.2009-06-23
ARTHROCARE SYSTEM 15000 CONTOLLER, MODEL 72202149, ARTHROCARE ARTHROWANDS, MODEL 72202139,72202141, 72202143, 72202144 (K090393)Arthrocare Corp.2009-06-23
ARAGON SURGICAL RF SYSTEM L2 INSTRUMENT (K090306)Aragon Surgical, Inc.2009-06-18
KLS MARTIN ELECTROSURGICAL INSTRUMENTS (K082505)Kl Martin L.P.2009-06-12
PEAK PLASMABLADE TNA TONSIL AND ADENOID TISSUE DISSECTION DEVICE (K083415)Peak Surgical, Inc.2009-06-05
ELLMAN INTERNATIONAL NON-ABLATIVE TECHNIQUE FOR SURGITRON IEC (K082834)Ellman Int'L, Inc.2009-05-07
MODEL P8400 HEMOSTATIX THERMAL SCALPEL SYSTEM (K091107)Hemostatix Medical Technologies, LLC2009-05-01
ISKRA MEDICAL GREEN IRF PRESTIGE (K083590)Iskra Medical, D.O.O.2009-04-17
EL LIGHTWAVE SUCTION ABLATOR, MODEL EL-2000-S, LIGHTWAVE SUCTION ABLATOR, MODEL IA-2000-S, LIGHTWAVE ABLATOR, MODEL IA- (K083281)Linvatec Corp.2009-02-25
HALO ABLATION CATHETER (K083737)Barrx Medical, Incorporated2009-02-10
ADVANCED MEDICAL INNOVATIONS DISPOSABLE TROCARS AND LAPAROSCOPIC ACCESSORIES (K081398)Advanced Medical Innovations, Inc.2009-02-06
MODIFICATION TO: HALO COAGULATION CATHETER, MODELS 32041-18, 32041-20, 32041-22, 32041-25, 32041-28, 32041-31, 32041-34 (K083711)Barrx Medical, Incorporated2009-02-02
SMITH & NEPHEW BIPOLAR ADAPTER CABLE, MODEL 72200022 (K083528)Smith & Nephew, Inc.2009-01-28
INTRACEPT FLEXIBLE BI-POLAR RF PROBE AND CURVED INSTRUMENT SET, MODELS: FG0018, FG0026 (K083856)Relievant Medsystems, Inc.2009-01-22
ETHICON ENDO-SURGERY ARTICULATING HOOK KNIFE, MODEL IN4505 (K082955)Ethicon Endo-Surgery, Inc.2009-01-15
STINGRAY ELECTROSURGICAL FORCEPS (K083162)Stingray Surgical Products, Inc.2009-01-12
ERBE MODEL VIO 300 D WITH ACCESSORIES (K083452)Erbe USA, Inc.2008-12-31
3.5 MM SIDE EFFECT ELECTRODE WITH INTEGRATED HANDPIECE, MODEL 227301, 3.5 MM ANGLED SIDE EFFECT ELECTRODE WITH INTEGRATE (K082643)Depuy Mitek, A Johnson & Johnson Company2008-12-19
ALPHA ORTHOPAEDICS AT2 SYSTEM (K082956)Alpha Orthopaedics2008-12-18
MEGA SOFT REUSABLE PATIENT RETURN ELECTRODE (K080741)Megadyne Medical Products, Inc.2008-12-16
MODIFICATION TO ARTHROCARE ARTHROWANDS (K083306)Arthrocare Corp.2008-12-10
RZ ENDOSCOPIC (MINIMALLY INVASIVE) INSTRUMENTS AND ACCESSORIES (K082902)Rz Medizintechnik GmbH2008-12-10
PK DIEGO POWERED DISSECTOR CONSOLE, MODEL 7033-9050, DIEGO TRIGGER-ENABLED POWERED DISSECTOR HANDPIECE, MODEL 7033-9001 (K083013)Gyrus Acmi, Inc.2008-12-09
TIVAMED COOLED RF SYSTEM, MODEL 78001 (K082962)Tivamed, Inc.2008-12-04
PULSAR GENERATOR, PEAK PLASMABLADE; 4.0, NEEDLE, AND EXT TISSUE DISSECTION DEVICES (K082786)Peak Surgical, Inc.2008-12-03
SALINE ENHANCED ELECTROSURGICAL RESECTION (SEER) DEVICE (K082568)Bovie Medical2008-11-17
ARTHROCARE ARTHROWANDS (K082980)Arthrocare Corp.2008-11-05
ARAGON ONESHOT SYSTEM (K081312)Aragon Surgical, Inc.2008-10-31
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