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GEI

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

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RecordFirmDate
REPROCESSED RF ARTHROSCOPY PROBES (K012679)Sterilmed, Inc.2001-11-08
TISSUE GRASPING FORCEPS, SCISSORS, CLAMPS AND DISSECTORS FOR LAPAROSCOPIC SURGERIES (K012725)Endo-Therapeutics, Inc.2001-11-08
SURGITRON 120 IEC (ALSO KNOWN AS SURGITRON 4.0 DUAL RF (K013255)Ellman Intl., Inc.2001-11-07
VANGUARD REPROCESSED ENDOSCOPIC INSTRUMENTS (K012700)Vanguard Medical Concepts, Inc.2001-11-07
VANGUARD REPROCESSED ARTHROSCOPIC WANDS (K012695)Vanguard Medical Concepts, Inc.2001-10-30
MODIFICATION TO: ERBE APC CONNECTOR HOSE AND PROBES, MODELS 20132-158, 20132-155, 20132-156, 20132-157, 20132-166 (K013348)Erbe USA, Inc.2001-10-26
ARTHROCARE ELECTROSURGERY WANDS (K012519)Arthrocare Corp.2001-10-25
REPROCESSED UNIPOLAR LAPAROSCOPIC/ENDOSCOPIC INSTRUMENTS (K012625)Alliance Medical Corp.2001-10-22
LEVEEN ELECTRODE (K012315)Radiotherapeutics Corp.2001-10-11
MODIFICATION TO: THERMACOOL IIA (K013034)Thermage, Inc.2001-10-04
BIPOLAR IRRIGATION FORCEPS (K012986)Aesculap, Inc.2001-10-03
EASY GUIDE ELECTROSURGICAL ACCESS DEVICE (K012004)Senorx, Inc.2001-09-25
MULTIFUNCTION ENDOSCOPIC INSTRUMENT (K012033)Seedling Enterprises., LLC2001-09-20
HANDPIECE SHEATH-MODEL #A910 (K011929)Aaron Medical, Inc.2001-09-18
ES-2000 SHAPE SELECT ELECTROSURGICAL SCALPEL (K012799)Senorx, Inc.2001-09-04
MODIFICATION TO:ENDIUS BIPOLAR SHEATH (K012488)Endius, Inc.2001-08-30
ATRICURE BIPOLAR COAGULATION SYSTEM (K011722)AtriCure, Inc.2001-08-30
ORTHO DEVELOPMENT ORION-I EMF SYSTEM (K012129)Ortho Development Corp.2001-08-22
ENTEC EVAC PLASMA WAND (K011279)Arthrocare Corp.2001-07-19
ARTHROCARE CONTROLLER, MODEL H2000; ARTHROCARE CABLE, MODEL H0970-02; FOOTSWITCH, MODEL H2000-04; POWERCORD, MODEL H2000 (K011634)Arthrocare Corp.2001-06-19
NTERO NOMAD SYSTEM (K010815)Ntero Surgical, Inc.2001-06-15
EN BLOC BIOPSY SYSTEM (K003190)Neothermia Corp.2001-06-11
ESU HANDSWITCHING PENCIL (K001442)Surgex, Inc.2001-05-31
SEEDLING ENTERPRISES LLC, COOL TEC MONOPOLAR AND BIPOLAR REUSABLE ELECTRODES (K010710)Seedling Enterprises., LLC2001-05-18
DENSTAT (K010465)Elmed, Inc.2001-05-14
MODIFICATION TO TISSUELINK BIPOLAR FORCEPS (K010661)Tissuelink Medical, Inc.2001-05-03
BIPOLAR PENCIL, MODEL 3901-002, 3900-002 (K010487)Medtronic PS Medical2001-05-03
MODIFICATION TO TISSUELINK MONOPOLAR FLOATING BALL (K010662)Tissuelink Medical, Inc.2001-04-27
COBRA 1/2 FLEX SURGICAL PROBE, MODEL 1593X; COBRA FLEX SURGICAL PROBE MODEL 1594X (K010956)Boston Scientific Corp2001-04-13
BIPOLAR TRIGGER-FLEX PROBE (K003126)Ellman Intl., Inc.2001-04-11
MULTIFUCTION SUCTION IRRIGATION SYSTEM, EXISTING OF SUCTION IRRIGATION HANDLES, SUCTION IRRIGATION TUBES, AND TUBE SETS; (K002000)Richard Wolf Medical Instruments Corp.2001-04-10
ULTRACISION HARMONIC SCALPEL COAGULATING SHEARS, MODEL LCSC5,LCSC1,CS23C,CS231,CS14C,CS141,LCSB5,LCSK5,LCS15,LCS16,CS150 (K002981)Ethicon Endo-Surgery, Inc.2001-04-09
RITA MODEL 2500 ELECTROSURGICAL RF GENERATOR (K003676)Rita Medical Systems2001-04-09
BAYLIS MEDICAL RF PERFORATION PROBE, MODEL RFP-265 (K010265)Baylis Medical Co., Inc.2001-04-09
BIPOLAR COAGULATION SYSTEM (K010112)Enable Medical Corp.2001-04-02
VALLEYLAB LIGASURE PRECISE INSTRUMENT VESSEL SEALING SYSTEM-MODEL # LS1200 & SLIGAURE GENERATOR (K010010)Valleylab, Inc.2001-04-02
ENDOSCOPIC TUBE SHAFT INSTRUMENTS FOR MONOPLAR COAGULATION (K010192)Antyllos Medizintechnik GmbH2001-04-02
LIGASURE LAPAROSCOPIC SEALER DIVIDER MODEL LS1100 (K010013)Valleylab, Inc.2001-03-26
ENDIUS BIPOLAR SHEATH (K003897)Endius, Inc.2001-03-22
INSTRUMENTS FOR LAPAROSCOPY 5 MM, 10 MM WITH COLOURED HANDLE, DETACHABLE ENDODCOPIC INSTRUMENTS 5 MM, 10MM (HANDLE, SHAF (K003717)Tekno Medical Optik-Chirurgie GmbH & Co.2001-03-01
ADVANTAGE SINGLE-USE ELECTROSURGICAL ATTACHMENT-J-HOOK TIP, L-HOOK TIP, CORBITT SPATULA TIP, BALL TIP, NEEDLE TIP (K010444)C.R. Bard, Inc.2001-02-28
ELECTRICATOR MODEL 26000 (K010025)Dermatologic Lab & Supply, Inc.2001-02-22
CONTROL MODULE ALGORITHM ENHANCEMENT FOR THE MODEL S500-ST AND MODEL S400 (K010210)Curon Medical, Inc.2001-02-21
MICTEC ENDOSCOPES AND ACCESSORIES (K002877)Dufner Instrumente GmbH2001-02-05
CLEAN SCRAPE (K003773)Webb Research Ii, Inc.2001-02-02
RITA STARBURST XLI ELECTROSURGICAL DEVICE (K010060)Rita Medical Systems2001-01-23
ERBE APC HANDLE AND APPLICATORS, MODEL 20132-043,20132-031,20132-032,20132-033,20132-034,20132-040,20132-044,20132-045 (K003462)Erbe USA, Inc.2001-01-04
ELECTROSURGICAL PROBES AND DEVICES-GELTX (K002269)Ximed/Prosure/Injectx2001-01-04
CRYOSURGICAL UNIT AND ACCESSORIES (K003050)Cryogen, Inc.2000-12-26
AARON 1250 HIGH FREQUENCY ELECTROSURGICAL GENERATOR, MODEL A1250 (K001955)Aaron Medical Industries2000-12-22
REFINITY SYSTEM, REFINITY HANDPIECE AND CABLE, REFINITY FOOTSWITCH, REFINITY POWER CORD, MODEL V5100-00,V5701-00,V5702 (K003624)Arthrocare Corp.2000-12-20
MODIFICATION TO VNUS CLOSURE SYSTEM (K003092)Vnus Medical Technologies, Inc.2000-12-18
PST ELECTROSURGICAL GENERATOR, MODEL 2150, PST BIPOLAR FORCEPS, MODEL EBF 1228 (K003249)Pst, Inc.2000-12-12
TISSUELINK BIPOLAR FORCEPS (K003005)Tissuelink Medical, Inc.2000-12-08
NEZHAT-DORSEY REUSABLE ELECTROSURGICAL ATTACHMENTS: J-HOOK TIP, L-HOOK TIP, CORBITT SPATULA TIP, NEEDLE TIP, BALL TIP (K003674)Davol Inc., Sub. C. R. Bard, Inc.2000-12-08
COOL-TEC ELECTRODES (K002841)Seedling Enterprises., LLC2000-12-08
THERMAGE THERMACOOL II SYSTEM (K003183)Thermage, Inc.2000-12-08
CLEARGLIDE PRECISION BIPOLAR DEVICE (K003587)ETHICON, Inc.2000-12-04
REDTRONIC XOMED MONOPOLAR ENERGIZED BLADE (K002987)Xomed, Inc.2000-12-04
MAGNA TEK ESU-400 (K003471)Huttinger Medizintechnik GmbH & CO KG2000-11-20
BAYONET FORCEPS BIPOLAR IRRIGATING (K002752)Q2 Medical2000-11-20
TISSUELINK MONOPOLAR FLOATING BALL' (K002680)Tissuelink Medical, Inc.2000-11-13
PILLING E-FRAZIER BIPOLAR SUCTION TUBE (K002582)Pilling2000-11-03
PLASMAKINETIC GENERATOR (K003060)Everest Medical Corp.2000-10-31
TECNO DISPOSABLE FINGERSWITCH PENCIL, MODEL 150-100 (K002257)Tecno Instruments (Pvt.) , Ltd.2000-10-19
CURON CONTROL MODULE ELECTROSURGICAL GENERATOR AND ACCESSORIES, MODEL S500-ST (K002898)Curon Medical, Inc.2000-10-17
SURGITRON IEC II (K001986)Ellman Intl., Inc.2000-09-27
VARPR 3.5MM 90 SUCTION ELECTRODE FOR USE WITH VAPR SYSTEM (K002422)Mitek Products2000-08-31
HEMOSTATIX THERMAL SCALPEL SYSTEM - #12 BLADE (K002021)Gyrus Ent LLC2000-08-24
SUREFIT DISPERSIVE ELECTRODE (K002002)Conmedcorp2000-08-17
SURGITRON IEC II (K001407)Ellman Intl., Inc.2000-07-24
COOL-TEC ELECTRODES (K001723)Seedling Enterprises., LLC2000-07-19
ARTHROCARE CONTROLLER, ARTHROCARE CABLE, FOOTSWITCH, POWERCORD (K001936)Arthrocare Corp.2000-07-19
THERMAGE THERMACOOL SYSTEM (K000944)Thermage, Inc.2000-07-19
ARTHROCARE FLOW CONTROL UNIT (K001904)Arthrocare Corp.2000-07-17
ELECTROSURGICAL ELECTRODE FAMILY, MODEL 20-2 NEEDLE BALLOON CATHETER, MODEL 40-4 NEEDLE BALLOON CATHETER, MODEL 60-6 NEE (K001150)Novasys Medical, Inc.2000-06-29
ELECTROSURGICAL ELECTRODE FAMILY (K001151)Novasys Medical, Inc.2000-06-27
AARON 2100 HIGH FREQUENCY ELECTROSURGICAL GENERATOR (K001382)Aaron Medical Industries2000-06-27
THERMAL CAUTERY FORCEPS (K001262)Starion Instruments2000-06-14
STARION INSTRUMENTS POWER POINT CAUTERY CLAMP (K001273)Starion Instruments2000-06-14
MODIFICATION TO STATSIGN SALINE ELECTROLYTE GEL, GRAHAM-FIELD SALINE ELECTROLYTE GEL (K001593)Chester Labs, Inc.2000-06-14
ULTRAPEN REUSABLE PENCIL, MODEL 130350 THROUGH 130353, REUSABLE ACCESSORY ELECTRODE KIT (FOR USE WITH ULTRAPEN PENCIL), (K001161)Conmedcorp2000-06-07
HYFRECATOR 2000 REUSABLE HAND-SWITCHING ACCESSORY HANDPIECE/FOOT-SWITCHING ACCESSORY HANDPIECE, HYFRECATOR PLUS REUSABL (K001159)Conmedcorp2000-06-07
HM-930 ELECTROSURGICAL UNIT (K993991)Hill-Med, Inc.2000-05-30
SOVEREIGN BIPOLAR INSTRUMENTS (K001330)Aesculap, Inc.2000-05-30
ARTHROCARE SYSTEM 2000 CONTROLLER, ARTHROCARE SYSTEM 2000 CABLE, ARTHROCARE SYSTEM 2000 FOOTSWITCH, PLASMA SCALPEL GS, C (K001302)Arthrocare Corp.2000-05-30
SOMNUS DISPOSABLE TISSUE COAGULATING ELECTRODE AND SOMNUS REUSABLE CONNECTOR CABLE (K000720)Somnus Medical Technologies, Inc.2000-05-30
SURGITRON IEC II (K001253)Ellman Intl., Inc.2000-05-26
GEIGER NEEDLE ADAPTER, MODEL 406 (K001029)Geiger Medical Technologies, Inc.2000-05-23
SOMNUS MODEL S2 ELECTROSURGICAL GENERATOR (K001438)Somnus Medical Technologies, Inc.2000-05-16
COLORADO MICRODISSECTION NEEDLE (K000348)Stryker Leibinger2000-05-03
ENTEC REFLEX WAND 55, MODEL E4055-01, E4045-01 (K000778)Arthrocare Corp.2000-05-03
ACTIVE ELECTRODE MONITORING SYSTEM (K000480)Electroscope, Inc.2000-05-02
EVERSHEARS BIPOLAR SCISSORS (K000496)Everest Medical Corp.2000-04-24
VAPR 2.3MM WEDGE ELECTRODE FOR USE WITH VAPR SYSTEM (K000936)Mitek Products2000-04-19
AARON 900 HIGH FREQUENCY DESSICCATOR/HANDPIECE (K000961)Aaron Medical Industries2000-04-19
CSM STRETTA SYSTEM (K000245)Conway Stuart Medical, Inc.2000-04-18
MICROGRASP BIPOLAR COAGULATOR, MODELS 90048-90057 (K000911)Hysterx, Inc.2000-04-14
RADIOTHERAPEUTICS RF 3000 RADIOFREQUENCY GENERATOR (K000241)Radiotherapeutics Corp.2000-04-14
LEVEEN NEEDLE ELECTRODE (K982556)Radiotherapeutics Corp.2000-04-06
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