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GEI

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

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RecordFirmDate
E-Z PEN, REUSEABLE HANDSWITCHING PENCIL (K050102)Megadyne Medical Products, Inc.2005-02-01
THERMAGE THERMACOOL SYSTEM (K043402)Thermage, Inc.2005-01-14
LIGASURE VESSEL SEALING SYSTEM. LIGASURE INSTRUMENTS (K043273)Valleylab2005-01-05
SERFAS ENERGY SYSTEM (K041810)Stryker Endoscopy2004-12-21
CARDIOBLATE DISPERSIVE ELECTRODE ADAPTER (ACCESSORY), MODEL 60884 (K043291)Medtronic Vascular2004-12-21
SURGRX ENSEAL VESSEL SEALING & HEMOSTASIS SYSTEM (K043008)Surgrx, Inc.2004-11-17
SMOKE EVACUATION ATTACHEMENT (K033095)Modern Medical Equipment Mfg., Ltd.2004-11-17
COOL-TIP RF ABLATION SYSTEM (K042216)Valleylab2004-11-12
STELLARTECH COAGULATION SYSTEM, MODELS 1100C-115A & 1100C-230A (K042909)Stellartech Research Corp.2004-11-12
GENICON BIPOLAR FORCEPS MODEL # 600-005-005 (K041968)Genicon2004-11-03
BITECH BIPOLAR SCISSORS (K042077)Guenter Bissinger Medizintechnik GmbH2004-10-27
VALLY FORGE SCIENTIFIC MALIS BIPOLAR DISPOSABLE FINGER OPERATED ELECTROSURGICAL INSTRUMENTS (K042604)Valley Forge Scientific Corp.2004-10-22
GYRUS PLASMACISION LAPAROSCOPIC SPATULA (K041633)Gyrus Medical, Inc.2004-10-22
TECNO REUSABLE BIPOLAR CABLES, MODEL 190-100 AND 190-110 (K042608)Tecno Instruments (Pvt.) , Ltd.2004-10-18
ERBE BICLAMP OPEN AND LAPAROSCOPIC INSTRUMENTS (K033421)Erbe USA, Inc.2004-10-14
LIGASURE PRECISE MODEL #LS1200/LIGASURE 5MM LAPAROSCOPIC SEALER DIVIDER MODEL # LS1500 (K041587)Valleylab2004-09-28
VALUPEN,PROFILE (K041868)Conmed Corporation2004-09-28
GYRUS G3 SYSTEM (GENERATOR, ASSESSORIES, SOMNOPLASTY ELECTRODES AND PLASMACISION ELECTRODES) (K041285)Gyrus Medical , Ltd.2004-09-10
EN-BLOC BIOPSY SYSTEM MODEL#777-110,777-001,777-002,777-006,777-301,777-302,777-115,777-120 (K042170)Neothermia Corporation2004-09-07
GUIDANT VASOVIEW 6 HARVESTING CANNULA, MODEL VH-2000; GUIDANT VASOVIEW 6 ACCESSORY PACK, MODEL VH-2004 (K041981)Guidant Corporation2004-08-20
SENORX INTRODUCER (K042098)Senorx, Inc.2004-08-19
SHINMED VARIOUS MODELS OF ELECTRO-SURGICAL PENCILS, SW12200, SW12202, SW12300 (K033027)Shining World Health Care Co., Ltd.2004-08-12
MSI S-500L RF GENERATOR (K041980)Medsphere International, Inc.2004-08-06
PLASMAJET SYSTEM (K030819)Plasma Surgical, Ltd.2004-08-05
COBRA ADHERE SURGICAL SYSTEM (K041599)Estech, Inc.2004-07-27
REPROCESSED SURGICAL SCISSORS AND GRASPERS (K033592)Clearmedical, Inc.2004-07-27
SMITH & NEPHEW ELECTROBLADE RESECTOR/ADAPTOR (K041328)Smith & Nephew, Inc.2004-07-27
THERMAGE THERMACOOL SYSTEM (K040135)Thermage, Inc.2004-06-21
LAPASCOPIC INSTRUMENTS AND ELECTRODE TIPS (K030831)Modern Medical Equipment Mfg., Ltd.2004-06-15
MODERN MEDICAL BIPOLAR FORCEPS (K032327)Modern Medical Equipment Mfg., Ltd.2004-06-15
STELLARTECH COAGULATION SYSTEM, MODELS 1100C-115 AND 1100C-230 (K041383)Stellartech Research Corp.2004-06-14
VNUS RADIOFREQUENCY GENERATOR, MODEL RFG2 (K040638)Vnus Medical Technologies, Inc.2004-06-07
MODIFICATION TO EN-BLOC BIOPSY SYSTEM (K041347)Neothermia Corp.2004-06-04
LAPAROSCOPIC ELECTRODE, REUSABLE INDICATOR SHAFT (LERIS) (K040699)Megadyne Medical Products, Inc.2004-06-04
SUCTION COAGULATOR (K033003)Modern Medical Equipment Mfg., Ltd.2004-05-13
LAPAROSCOPIC INSTRUMENT, ELECTRODE AND CABLE (K032965)Modern Medical Equipment Mfg., Ltd.2004-05-13
RITA SYSTEMS (K040989)Rita Medical Systems2004-04-28
CONCERTO BIPOLAR NEEDLE ELECTRODE (K040785)Boston Scientific Corp2004-04-28
NMX-1000 (K040584)Neomedix Corp.2004-04-22
INSTRUMED LAPAROSCOPE AND ACCESSORIES (K040855)Instrumed International, Inc.2004-04-16
RESECT MEDICAL INLINE BI-POLAR RF LINEAR COAGULATION DEVICE (K040763)Resect Medical, Inc.2004-04-08
MSI MODEL S-500 RF GENERATOR (K033888)Medsphere International, Inc.2004-04-02
STELLARTECH COAGULATION SYSTEM (MODELS 1100C-115 & 1100C-230) (K040240)Stellartech Research Corp.2004-04-01
ELECTRO-LUBE (K033880)Mectra Labs, Inc.2004-03-10
VIVARING MICROWAVE ABLATION PROBE (K040279)Vivant Medical, Inc.2004-03-02
ARTHROCARE CONTROLLER, CABLE, FOOT CONTROL, POWER CORD, WANDS, MODELS H0970-02, H2000-04, H2000-05, H0970-06 (K040338)Arthrocare Corp.2004-03-01
COLORADO MICRODISSECTION NEEDLE (K033232)Stryker Corp.2004-02-25
SMITH & NEPHEW ELECTROTHERMAL 20S SPINE GENERATOR, MODEL 7209975 (K033981)Smith & Nephew, Inc.2004-02-25
COBRA SURGICAL PROBE (K040219)Boston Scientific Corp2004-02-24
MANOA BREAST BIOPSY SYSTEM (K033205)Manoa Medical, Inc.2004-02-18
COBRA ADHERE SURGICAL SYSTEM, MODEL M00415977C0 (K040104)Boston Scientific Corp2004-02-18
HEMOSTATIX, MODEL 2400Z THERMAL SCALPEL SYSTEM (K033089)Gyrus Ent LLC2004-02-05
THERMAGE THERMACOOL SYSTEM (K033942)Thermage, Inc.2004-02-04
MINIMALLY INVASIVE SOLUTIONS OSTEOTOMY GUIDE INSTRUMENT (K033652)Zimmer, Inc.2004-02-04
HELICA TC LAPAROSCOPIC CUTTING AND CAUTERISING (LTC) PROBE (K032969)Helica Instruments, Ltd.2004-02-04
VNUS VESSEL AND TISSUE COAGULATION SYSTEM (K033547)Vnus Medical Technologies, Inc.2004-01-07
SISS INC. (D.B.A. MEDISISS) REPROCESSED ELECTROSURGICAL INSTRUMENTS AND ACCESSORIES (K031869)Surgical Instruments Service and Savings, Inc.2003-12-24
TRIDENT RESECTION ABLATOR (K033748)Linvatec Corp.2003-12-15
ARTHROCARE ARTHROWANDS (K033584)Arthrocare Corp.2003-11-28
MALIS IRRIGATION MODULE 1000 (K033499)Valley Forge Scientific Corp.2003-11-28
GYRUS OPEN FORCEPS (K024286)Gyrus Medical, Inc.2003-11-17
ARTHROCARE ENT PLASMA WANDS (K033257)Arthrocare Corp.2003-10-30
COOK VASCULAR PERFECTA ELECTROSURGICAL DISSECTION SYSTEM ERGONOMIC INTERMITTENT ACTIVATION SWITCH (K032223)Cook Vascular, Inc.2003-10-15
CSS (K031564)Medical Scientific, Inc.2003-10-07
MODIFICATION TO: STELLARTECH COAGULATION SYSTEM (MODELS 1100C-115 & 1100C-230) (K032721)Stellartech Research Corp.2003-10-06
VIVATIP MICROWAVE ABLATION PROBE (K032702)Vivant Medical, Inc.2003-10-03
CELON ENT SYSTEM (K032838)Celon AG Medical Instruments2003-09-26
RUBICOR ENCAPSULE BREAST BIOPSY DEVICE, MODEL 30629 (K032584)Rubicor Medical, Inc.2003-09-17
TRANSDISCAL SYSTEM (TRANSDISCAL PROBE), MODEL TDP-17-150-6 (K031951)Baylis Medical Co., Inc.2003-09-11
RITA MODEL 1500X ELECTROSURGICAL RF GENERATOR (K032149)Rita Medical Systems, Inc.2003-09-09
MODIFICATION TO: STELLARTECH COAGULATION SYSTEM, MODELS 1100C-115 & 100C-230 (K032452)Stellartech Research Corp.2003-08-21
ARTHROCARE SYSTEM (K032504)Arthrocare Corp.2003-08-21
TISSUELINK FLOATING BALL MODEL 23-201-1 (K032132)Tissuelink Medical, Inc.2003-08-20
COBRA COOLED SURGICAL PROBE, MODEL M004159670 (K032207)Boston Scientific Corp2003-08-20
TRI-LOOP MICROWAVE ABLATION PROBE (K032047)Vivant Medical, Inc.2003-08-06
MODIFICATION TO THERMACOOL TC SYSTEM (K032088)Thermage, Inc.2003-08-01
STELLARTECH COAGULATION SYSTEM, MODELS (1100C-115 & 1100C-230) (K032062)Stellartech Research Corp.2003-07-29
GYRUS PLASMAKINETIC SUPERPULSE SYSTEM (GENERATOR, ACCESSORIES) (K031085)Gyrus Medical, Inc.2003-07-21
CARDIOVATIONS OPTICAL BIPOLAR DEVICE (K031846)ETHICON, Inc.2003-07-21
CARDIOBLATE BIPOLAR RADIOFREQUENCY SURGICAL ABLATION SYSTEM (K031247)Medtronic Vascular2003-07-17
RITA MODEL 1500X ELECTROSURGICAL RF GENERATOR AND ACCESSORIES (E.G., RITA THERMO PAD AND CABLE ADAPTER) (K031926)Rita Medical Systems, Inc.2003-07-17
UNIT, CAUTERY, TEHRMAL,BATTERY-POWERED (K030158)Walsh Medical Devices, Inc.2003-07-17
BAYLIS PAIN MANAGEMENT GENERATOR, MODELS PMG-115-TD AND PMG-230-TD (K031950)Baylis Medical Co., Inc.2003-07-17
SURGRX ENSEAL VESSEL SEALING AND HEMOSTASIS SYSTEM INCLUDING THE ENSEAL CONTROLLER ADAPTER, ENSEAL OPEN AND LAPAROSCOPIS (K031133)Surgrx, Inc.2003-07-03
SMITH & NEPHEW DYONICS ELECTROBLADE RESECTOR (K031675)Smith & Nephew, Inc.2003-06-20
ULTRABLATOR ELECTRODE (K030720)Linvatec Corp.2003-06-03
MSI SA ELECTRODES (K030996)Medsphere International, Inc.2003-05-30
LIGASURE 5MM LAPAROSCOPIC SEALER-DIVIDER, MODEL LS1500 (K031011)Valleylab, Inc.2003-05-29
SAPHYRE BIPOLAR ABLATION PROBES (K031371)Smith & Nephew, Inc.2003-05-23
THERMACOOL TC SYSTEM (K031046)Thermage, Inc.2003-05-22
CODMAN ISOCOOL BIPOLAR FORCEPS (K023566)Codman & Shurtleff, Inc.2003-05-22
EVEREST LP BIPOLAR SCISSORS AND GYRUS LP BIPOLAR SCISSORS (K031081)Gyrus Medical, Inc.2003-05-21
EVEREST BIPOLAR NEEDLE ELECTRODE & GYRUS BIPOLAR NEEDLE ELECTRODE (K031079)Gyrus Medical, Inc.2003-05-21
EVEREST BIPOLAR L HOOK & PK BIPOLAR L HOOK (K031082)Gyrus Medical, Inc.2003-05-21
MEGA 2000 SOFT DUAL CORD PATIENT RETURN ELECTRODE PAD (K031285)Megadyne Medical Products, Inc.2003-05-19
EVEREST BIPOLAR MACRO, MICRO & MOLLY FORCEPS & GYRUS BIPOLAR MACRO, MICRO & MOLLY FORCEPS (K031078)Gyrus Medical, Inc.2003-05-16
EVEREST BIPOLAR LYONS DISSECTING FORCEPS & GYRUS BIPOLAR LYONS DISSECTING FORCEPS (K031080)Gyrus Medical, Inc.2003-05-16
COA-COMP/M, AUTOMATED BIPOLAR COAGULATOR (K023733)Ingenjorsfirman Bjorn Bergdahl AB2003-05-14
RITA MODEL 1500X ELECTROSURGICAL RF GENERATOR (K031257)Rita Medical Systems, Inc.2003-05-02
RITA STARBURST SDE ELECTROSURGICAL DEVICE (K030967)Rita Medical Systems2003-04-21
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