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GEI

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

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RecordFirmDate
NCONTACT COAGULATION SYSTEM KIT (K062539)Ncontact Surgical, Inc.2006-12-01
LINA POWERBLADE, MODEL 5005,5005-E,5005-C,5005-150,5000-C-150,5005-E-C-150,5005-420,5005-C-420,5005-E-420,5005-E-C-420, (K063025)Lina Medical Aps2006-12-01
ARTHROCARE CONTROLLER (SYSTEM 2000 AND 8000), ARTHROCARE PATIENT CABLE, FOOT CONTROL, POWER CORD AND WANDS (K063538)Arthrocare Corp.2006-12-01
LIGASURE ADVANCE LAPAROSCOPIC SEALER/DIVIDER WITH DISSECTING ELECTRODE, MODELS LF5034 AND LF5044 (K063195)Valleylab2006-11-29
SKINTACT COOL CONTACT ELECTROSURGICAL GROUNDING PLATE WITH NH 04 GEL (K063161)Leonhard Lang GmbH2006-11-21
ELECTROSURGICAL CUTTING AND COAGULATION DEVICE AND ACCESSORIES (K061829)New Leaf Medical, Inc.2006-11-17
BARRX HALO COAGULATION SYSTEM; GENERATOR, MODEL 90-9000; OUTPUT CABLE, MODEL 90-9010; FOOTSWITCH, MODEL 90-9020 (K062441)Barrx Medical, Incorporated2006-11-14
HALO90 COAGULATION CATHETER (K062723)Barrx Medical, Incorporated2006-11-09
ELECTRODE COATED BALL, MODEL AB302C; NEEDLE, MODEL AN301C; BLADE, MODEL AE301HC (K061878)E Surgical, LLC2006-10-24
ENSEAL PTC TISSUE SEATING SEALING DEVICE (K062949)Surgrx, Inc.2006-10-18
ENSEAL PTC TISSUE SEALING DEVICE (K063097)Surgrx, Inc.2006-10-18
POLARCOAT (K052907)Patton Surgical Corp.2006-10-16
HABIB 4X LAPAROSCOPIC (K062935)Rita Medical Systems2006-10-13
STELLARTECH 100 COAGULATION SYSTEM (K061544)Stellartech Research Corp.2006-10-13
THERMASSAGE (K061001)Thermage, Inc.2006-10-12
STRYKER RF PARALLEL BIPOLAR ADAPTOR CABLE (K061660)Stryker Instruments2006-10-10
GENICON DISPOSABLE ELECTROSURGICAL INSTRUMENTATION, MODEL 533-005-910 (K061417)Genicon2006-10-10
STARION INSTRUMENTS THERMAL LITIGATING SHEARS (K062257)Starion Instruments2006-10-10
ADAPTABLE MONOPOLAR ADAPTABLE AND/OR RETRACTABLE ELECTRODES (K062047)PAJUNK GmbH Medizintechnologie2006-10-05
MODULAR LAPAROSCOPY ACCESSORIES, HANDLE; SISSORS (STRAIGHT AND CURVED); GRASPER (AGGRESSIVE, ALLIS, ATAUMATIC; DISSECTOR (K062337)Aaron Medical Industries2006-10-05
PAJUNKS DISPOSABLE INSERTS FOR HANDLE INSTRUMENTS AND HF ELECTRODES (K062072)PAJUNK GmbH Medizintechnologie2006-09-22
STRYKER DISPOSABLE LAPAROSCOPIC SCISSORS (K061225)Stryker Corp.2006-09-14
STRYKER SILVERGLIDE BIPOLAR FORCEPS REUSABLE CABLE; DISPOSABLE CABLE (K061835)Stryker Instruments2006-09-08
BOVIE ICON GI ELECTROSURGICAL GENERATOR, MODEL GI 120 (K061884)Bovie Medical2006-09-06
PORTRAIT PSR3 (K060948)Rhytec Incorporated2006-09-05
MSD BIPOLAR FORCEPS (K061635)Medtronic Sofamor Danek2006-09-05
HALO COAGULATION CATHETER (K062225)Barrx Medical, Incorporated2006-08-28
PUREWRIST SCISSORS, MODEL PW1101-01;PUREWRIST DISSECTOR, MODEL PW1201-01;PUREWRIST HOOK, MODEL PW1301-01 (K061425)Cambridge Endoscopic Devices2006-08-10
PLASMASEAL OPEN FORCEPS, MODELS 2103PK AND 91701PK (K061975)Acmi Corporation2006-08-10
VNUS CLOSUREFAST CATHETER, MODELS CF7-7-60 AND CF7-7-100 (K061373)Vnus Medical Technologies, Inc.2006-08-01
BOVIE INAFLASH SUTURE REMOVER HANDLE,CHARGER,HANDLE AND CHARGER,KIT,BATTERY PACK (K061307)Aaron Medical Industries2006-07-18
TROKAMED GMBH ELECTROSURGICAL INSTRUMENTS & ACCESSORIES (K060232)Trokamed GmbH2006-07-12
SURGI-MAX (K061174)Ellman Int'L, Inc.2006-06-28
ENSEAL PTC TISSUE SEALING DEVICE (K061526)Surgrx, Inc.2006-06-15
DAN MONOPOLAR LAP ACCESSORIES (K052759)Dannoritzer Medizintechnik GmbH & Co. KG2006-06-14
TRABECTOME HIGH FREQUENCY GENERATOR/LP (K061258)Neomedix Corp.2006-05-18
MODIFICATION TO ARTHROCARE PERC-D SPINEWAND (K061259)Arthrocare Corp.2006-05-18
BARRX HALO COAGULATION SYSTEM, BARRX HALO COAGULATION GENERATOR, BARRX COAGULATION CATHETER, MODELS 2200-115A, 1520F (K060169)Barrx Medical, Incorporated2006-04-21
ARTHROCARE WANDS (K060823)Arthrocare Corp.2006-04-10
E SURGICAL ELECTROSURGICAL PATIENT RETURN ELECTRODE, DUAL PLATE WITH CORD AND ELECTROSURGICAL PATIENT RETURN ELECTRODE (K060255)E Surgical, LLC2006-03-31
POREX ELECTROSURGERY NEEDLE (K052297)Porex Surgical, Inc.2006-03-28
IR WIRELESS FOOT SWITCH (K053510)Linemaster Switch Corp.2006-03-20
ERBE VIO ESU, MODEL VIO 300 D (K060484)Erbe USA, Inc.2006-03-16
COOL-TIP RF GENERATOR, COOL-TIP RF SYSTEM ACCESSORIES (K053290)Valleylab2006-03-15
CONCERTO BIPOLAR NEEDLE ELECTRODE (K060419)Boston Scientific Corp2006-03-13
CARDIOBLATE SURGICAL ABLATION GENERATOR, MODEL 68000; CARDIOBLATE BP2 SURGICAL ABLATION DEVICE, MODEL 60831; CARDIOBLAT (K060400)Medtronic, Inc.2006-02-28
BOVIE BUTTON REMOTE HAND SWITCH (K060117)Aaron Medical Industries2006-02-22
ERBE APC INTEGRATED FILTER PROBES; ERBE APC INTEGRATED FILTER PROBE ADAPTER (K060183)Erbe USA, Inc.2006-02-16
ERBE BICLAMP OPEN AND LAPAROSCOPIC INSTRUMENTS (K060170)Erbe USA, Inc.2006-02-16
COOL-TIP RF GENERATOR, COOL-TIP RF SYSTEM ACCESSORIES (K052796)Valleylab2006-02-03
CAUTERY TIP CLEANER, MODEL 30500 (K053433)Xodus Medical, Inc.2006-01-19
ESTECH COBRA ELECTROSURGICAL UNIT & CABLE (K053326)Endoscopic Technologies, Inc.2006-01-06
ARTHROCARE PERC-D SPINEWAND (K053447)Arthrocare Corp.2005-12-27
ESTECH COBRA BIPOLAR SYSTEM (K053100)Endoscopic Technologies, Inc.2005-12-19
MODIFICATION TO THERMAGE THERMACOOL SYSTEM (K053365)Thermage, Inc.2005-12-13
ADAPTABLE MONOPOLAR ELECTRODES WITH CERAMIC TIP (K053282)Pajunk GmbH2005-12-13
ARTHROCARE 8000S COBLATOR SURGERY SYSTEM (K053297)Arthrocare Corp.2005-12-06
SOLOIST SINGLE NEEDLE ELECTRODEELECTRODE (K053128)Boston Scientific Corp2005-11-30
MISONIX INC. FS-1000-RF BIPOLAR FORCEPS ACCESSORY (K052702)Misonix, Inc.2005-11-21
GYRUS GENERAL PURPOSE ELECTROSURGICAL GENERATOR (K050550)Gyrus Medical, Inc.2005-11-09
ATRICURE TRANSPOLAR SYSTEM (K052893)AtriCure, Inc.2005-10-25
GYRUS PLASMACISION AND PLASMABLEND ELECTRODES (K050460)Gyrus Medical, Inc.2005-10-25
AQUAMANTYS PUMP GENERATOR SYSTEM (K052859)Tissuelink Medical, Inc.2005-10-25
ALUMA SKIN RENEWAL SYSTEM (K051214)Lumenis, Inc.2005-10-24
ELECTROSURGICAL GENERATOR SYSTEM, MODEL ES 3000 (K052857)Senorx, Inc.2005-10-21
ULTRACLEAN HANDCONTROLLED SUCTION COAGULATOR, MODEL 130182, 130183, 130184, 130185; ULTRACLEAN FOOTCONTROLLED SUCTION (K052104)Conmed Corporation2005-10-21
AURA 70 WATT BIPOLAR ELECTROSURGICAL COAGULATORS, MODELS 28-2000 AND 28-2600 (K052203)Kirwan Surgical Products, Inc.2005-10-20
THERMAGE THERMACOOL SKIN MARKETING (K052778)Thermage, Inc.2005-10-20
CADMAN INTEGRATED IRRIGATION TUBING AND BIPOLAR CORD SET, MODELS 80-1163, 80-1189 (K052449)Codman & Shurtleff, Inc.2005-10-17
VNUS RFS, MODEL RFS-6-XX (XX = 10, 12, 13, & 15); VNUS RFS FLEX, MODEL RFX-6-XX (XX = 10, 20, 30 & 40) (K052003)Vnus Medical Technologies, Inc.2005-10-11
STRYKER STILETTO ELECTROSURGICAL PROBE (K052141)Stryker Endoscopy2005-10-06
RUBICOR ENCAPSULE BREAST BIOPSY DEVICE, MODEL 31108 (K052506)Rubicor Medical, Inc.2005-10-06
ARTHROCARE ARTHROWANDS (K052686)Arthrocare Corp.2005-10-05
CONMED SYSTEM MODEL 2450 ELECTROSURGICAL GENERATOR (K052009)Conmed Corporation2005-09-28
GUIDANT VASOVIEW HEMOPRO ENDOSCOPIC VESSEL HARVESTING SYSTEM, MODEL VH-3000 (K052274)Guidant Corporation2005-09-21
COBRA SURGICAL SYSTEM (K051749)Estech, Inc.2005-09-13
DR. OPPEL ST-501 (K051956)Sometech Incorporated2005-09-08
GEMINI SURGICAL CONTROL & DISPLAY SYSTEM (K051831)Applied Surgical, LLC2005-09-07
CANADY PLASMA PROBES (K052035)Canady Technology, LLC2005-08-31
MODIFICATION TO EN-BLOC BIOPSY SYSTEM (K052246)Neothermia Corporation2005-08-22
HABIB 4X (K051420)Emcision , Ltd.2005-08-15
VALLEYLAB FORCETRIAD ELECTROSURGICAL GENERATOR (K051644)Valleylab2005-08-11
CLARIS NON-STICK BIPOLAR FORCEPS (K051429)Guenter Bissinger Medizintechnik GmbH2005-07-29
VALLEYLAB G3000 ELECTROSURGICAL INSTRUMENT (K051627)Valleylab2005-07-22
THERMAGE THERMACOOL COUPLING FLUID (K051710)Thermage, Inc.2005-07-19
BARRX HALO 360 SYSTEM, MODEL 1100C-115A (K051168)Barrx Medical, Incorporated2005-06-29
SMITH & NEPHEW VULCAN ARTICULAR CARTILAGE PROBE, MODEL 721XXXX (K050898)Smith & Nephew, Inc.2005-05-25
NON-STICK ELECTRODE (K043036)Modern Medical Equipment Mfg., Ltd.2005-05-06
STELLARTECH COAGULATION SYSTEM 2, MODELS 1100C-115A AND 1100C-230A (K050831)Stellartech Research Corp.2005-04-12
SURGITRON RADIOLASE II (K042710)Ellman Int'L, Inc.2005-04-07
ENSEAL VESSEL SEALING & HEMOSTASIS SYSTEM (K050671)Surgrx, Inc.2005-04-01
NEOTHERMIA EN-BLOC BIOPSY SYSTEM (K050737)Neothermia Corporation2005-03-31
MEGA POWER ELECTROSURGICAL GENERATOR (K050579)Megadyne Medical Products, Inc.2005-03-24
MODIFICATION TO CONCERTO BIPOLAR NEEDLE ELECTRODE (K050361)Boston Scientific Corp2005-03-14
MALIS 2000 BIPOLAR ELECTROSURGICAL SYSTEM (K050364)Valley Forge Scientific Corp.2005-03-09
GYRUS PLASMA SKIN RESURFACING SYSTEM (K041999)Gyrus Medical, Inc.2005-03-02
VIVAWAVE MICROWAVE ABLATION SYSTEM, COAXIAL INTRODUCER (K050223)Vivant Medical, Inc.2005-02-24
PSD-60/ENDOPLASMA (K042274)Olympus Shirakawa Co., Ltd.2005-02-22
ELECTROSURGICAL PENCILS (K040780)Hangzhou Shuyou Medical Instrument Company, Ltd.2005-02-10
SYSTEM 7500-B ELECTROSURGICAL UNIT; ABCFLEX PROBE FOR FLEXIBLE ENDOSCOPY (K050161)Conmed Electrosurgery2005-02-03
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