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GEI

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

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RecordFirmDate
Force TriVerse Electrosugical Device, Holster, 10-foot, Force TriVerse Electrosurgical Device, Holster, 15-foot (K150735)Covidien2015-08-04
Bovie J-Plasma Handpiece (K151325)Bovie Medical Corporation2015-08-04
Barrx Anorectal RFA Wand (K150251)Covidien, LLC2015-07-28
Caiman Seal and Cut Technology (K151858)Aesculap, Inc.2015-07-21
Caiman Seal and Cut Technology (K151696)Aesculap, Inc.2015-07-20
PROPENCIL Smoke Pencil (K143103)Bio Protech, Inc.2015-07-16
Habib EUS RFA (K150029)Emcision , Ltd.2015-06-24
OsteoCool V-2 RF Ablation System (K142480)Baylis Medical Company, Inc.2015-06-16
XP1000 RF (K143559)BTL Industries, Inc.2015-06-11
TD-Wand (K150824)Tdm Surgitech, Inc.2015-05-28
Cautery Tip Cleaner (K151222)Key Surgical, Inc.2015-05-22
PlasmaBlade UPPP and Suction Coagulator (K150297)Medtronic Advanced Energy2015-05-21
Venus Viva SR Device (K150161)Venus Concept , Ltd.2015-05-12
NICO TRIOwand (K150993)Nico Corporation2015-04-23
Voyant Fine Fusion Device (K143536)Applied Medical Resources2015-04-16
Monopolar Laparascopic Accessories (K142208)Unimicro Medical Systems (Shenzhen) Co., Ltd.2015-04-13
VAPR Tripolar Suction Electrode (K143475)Depuy Mitek2015-04-03
Valleylab LS10 Generator (K143654)Covidien, LLC2015-04-03
Voyant Open Sealer-Divider Device (K143517)Applied Medical Resources2015-03-27
Bissinger Monopolar Forceps and Cables (K143662)Medagent, Inc.2015-03-12
XP300 (K143109)BTL Industries, Inc.2015-03-06
AQANIFE (K141790)Ovesco Endoscopy AG2015-03-06
Prostiva RF Therapy Generator, Prostiva RF Therapy Hand Piece, Prostiva RF Therapy Return Electrode, Prostiva RF Therapy Tubing System, Prostiva RF Therapy Telescope (K142248)Urologix, Inc.2015-02-20
Bissinger Monopolar Cables (K150024)Guenter Bissinger Medizintechnik GmbH2015-02-20
E-Z CLEAR SMOKE EVACUATION ELECTROSURGICAL PENCIL;CLEAR NOZZLE EXTENTION, ULPA FILTER, CHARCOAL FILTER, ADAPTER (K141587)Megadyne Medical Products, Inc.2015-02-18
Ligasure Blunt Tip Sealer/Divider (K142929)Covidien2015-01-27
PK Cutting Forceps for ESG-400 Workstation (K142759)Gyrus Acmi, Inc.2015-01-13
PK J-HOOK (K142350)Gyrus Acmi, Inc.2015-01-08
Laparoscopic FMsealer (K142229)Domain Surgical, Inc.2015-01-02
PK Spatula (K142289)Gyrus Acmi, Inc.2014-12-31
AEx Generator; PlasmaBlade T (K143175)Medtronic Advanced Energy2014-12-31
PK NEEDLE (K142154)Gyrus Acmi, Inc.2014-12-19
Legacy BX (K142910)Venus Concept USA, Inc.2014-12-19
Force FX-8(S), Force FX-8C(S), Force FX-8CA(S) (K143161)Covidien2014-12-19
Bovie Ultimate High Frequency Electrosurgical Generator (K142975)Bovie Medical Corporation2014-12-12
HICURA HAND INSTRUMENTS (K140624)Olympus Winter & Ibe GmbH2014-12-10
TWO SKIN TREATMENT SYSTEM (K141507)Syneron Medical, Ltd.2014-12-08
SafeAir Smoke Pencil (K143145)Lina Medical Aps2014-12-04
INMODE WMFACE DEVICE (K140926)Inmode MD , Ltd.2014-12-03
DISPOSABLE LAPAROSCOPIC ELECTRODE, DISPOSABLE LAPAROSCOPIC ELECTRODE (K134006)Modern Medical Equipment Manufacturing Limited2014-11-21
5mm Laparoscopic Electrode with J Hook, 5mm Laparoscopic Electrode with L Hook, 5mm Laparoscopic Electrode with Spatula, Monopolar cable with 4mm pin, Monopolar cable with 8mm pin (K142868)Purple Surgical International Limited2014-11-21
EVac 70 Xtra Plasma Wand with Integrated Cable, PROcise XP Plasma Wand with Integrated Cable (K142999)ArthroCare Corporation2014-11-19
VIRTUOSAPH PLUS ENDOSCOPIC VESSEL HARVESTING SYSTEM (K140008)Terumo Cardiovascular Systems Corporation2014-10-31
KINGSTON ENDOSCOPIC SURGICAL INSTRUMENTS (K132771)Qingdao Kingston Medical Devices, Ltd.2014-10-28
LiNA PowerBlade Plus HC (K142757)Lina Medical Aps2014-10-23
VIORA V-TOUCH (K141904)Viora , Ltd.2014-10-21
LiNA SafeAir Smoke Pencil (K142538)Lina Medical Aps2014-10-06
Barrx RFA Self Sizing Balloon Catheter (K142364)Covidien, LLC2014-10-01
HARMONIC SCALLOP BLADE, GENERATOR G11 (K141122)Ethicon Endo-Surgery, LLC2014-09-15
VOYANT ELECTROSURGICAL GENERATOR, VOYANT 5MM LAPAROSCOPIC SEALER-DIVIDER DEVICE (K141288)Applied Medical Resources2014-08-22
BARRX FLEX RFA ENERGY GENERATOR (K141357)Covidien Iic2014-08-21
LIGASURE; CURVED SMALL JAW SEALER/DIVIDER, 5MM BLUNT TIP SEALER/DIVIDER, MARYLAND JAW ONE STEP STEALER/DIVIDERS, CURVED (K141153)Covidien2014-08-14
ESG-400, FOOTSWITCH DOUBLE PEDAL, FOOTSWITCH SINGLE PEDAL, P-CORD (K141225)Olympus Winter & Ibe GmbH2014-08-12
CLOSURERFG RADIOFREQUENCY GENERATOR (K141858)Covidien2014-08-05
VAPR ARCTIC SUCTION ELECTRODE (K140896)Depuy Mitek, A Johnson & Johnson Company2014-08-05
ONEPASS ENDOSCOPIC VESSEL HARVESTING SYSYETM (K140603)Saphena Medical, Inc.2014-07-31
OPEN FMSEALER (K141484)Domain Surgical, Inc.2014-07-30
L'DISQ (K132797)U&I Corporation2014-07-30
SKINTACT (K140500)Leonhard Lang GmbH2014-07-29
ARTHROSCOPIC ENERGY SYSTEM (K140578)Conmed Corporation2014-07-23
ALTRUS THERMAL TISSUE FUSION ENERGY SOURCE, ALTRUS THERMAL TISSUE FUSION HANDPIECE, ALTRUS THERMAL TISSUE FUSION SYSTEM (K140459)Conmed Corporation2014-07-11
THERMOGARD DISPERSIVE ELECTRODES, THERMOGARD PLUS ABC DISPERSIVE ELECTRODES (K140658)Conmed Corporation2014-07-10
VENUS SWAN(MP)2 (K140629)Venus Concept , Ltd.2014-06-25
ENDOSHIELD BURN PROTECTION SYSTEM (K140006)Encision, Inc.2014-06-16
TOPAZ EZ MICRODEBRIDER COBLATION WAND WITH INTEGRATED FINGER SWITCH (K140521)ArthroCare Corporation2014-06-10
HET SYSTEMS, LLC, HET BIPOLAR LIGATOR SYSTEM (K140422)Het Systems, LLC2014-06-05
MINNIE (K133405)Elettronica Valseriana Srl2014-05-23
FMWAND HANDPIECE SE (K140384)Domain Surgical, Inc.2014-05-23
THUNDERBEAT (K132703)Olympus Medical Systems Corp.2014-05-19
STOP U (PACKED BLACK USA); STOP U (PACKED WHITE USA) (K140255)Pollogen, Ltd.2014-05-14
CAIMAN SEAL AND CUT TECHNOLOGY (K140839)Aesculap, Inc.2014-04-28
LEVEEN STANDARD NEEDLE ELECTRODE, LEVEEN COACCESS NEEDLE ELECTRODE (K140495)Boston Scientific Corp2014-04-17
BOVIE IDS-310 HIGH FREQUENCY ELECTROSURGICAL GENERATOR, AARON A3350 HIGH FREQUENCY ELECTROSURGICAL GENERATOR (K134054)Bovie Medical Corporation2014-03-17
LIGER MEDICAL ESU-110 (K133273)Liger Medical, LLC2014-02-12
VESALIUS (K131696)Telea Electronic Engineering Srl2014-01-31
EPIX ELECTROSURGICAL PROBE SPATULA TIP, EPIX ELECTROSURGICAL PROBE L-HOOK TIP, EPIX ELECTROSURGICAL PROBE J-HOOK TIP, RE (K132300)Applied Medical Resources Corp.2014-01-24
MEGA SOFT UNIVERSAL PATIENT RETURN ELECTRODE (K133726)Megadyne Medical Products, Inc.2014-01-24
MONOPOLAR CAUTERY CORD, BIPOLAR CAUTERY CORD (K133167)Intuitive Surgical, Inc.2014-01-07
LIGASURE 5 MM MARYLAND JAW SEALER/DIVIDER ONE-STEP SEALING (LF 17XX) (K133338)Covidien, Formerly Valleylab, A Division of Tyco H2013-12-20
LINA POWERBLADE PLUS (K132837)Lina Medical Aps2013-12-19
SURGEN U (K131758)Pollogen, Ltd.2013-12-18
NEOGEN PSR SYSTEM (K132754)Energist, Ltd.2013-12-12
ERBE ESU MODEL VIO DV WITH ACCESSORIES (K133180)Erbe USA, Inc.2013-12-11
SINGLE USE & MULTI USE BIPOLAR FORCEPS / SINGLE USE & MULTI USE MONOPOLAR FORCEPS (K130669)Olsen Medical2013-12-06
AQUAMANTYS 2.3 BIPOLAR SEALER, EVS 4.0 EPIDURAL VEIN SEALER, MINI EVS 3.4 EPIDURAL VEIN SEALER, SBS 5.0 SHEATHED BIPOLAR (K132974)Medtronic Advanced Energy, LLC2013-12-03
HARVESTING CANNULA (K132743)Maquet Cardiovascular, LLC2013-12-03
SYMPHONY RF GENERATOR (K130689)Thermigen, Inc.2013-11-15
BIPOLAR FORCEPS (K131058)Boston Endo-Surgical Technologies, Inc.2013-10-25
MEDLINE SUCTION COAGULATOR (K122949)Medline Industries, Inc.2013-10-16
MEDDUSA BIPOLAR SYSTEM (K130110)Elliquence, LLC2013-10-08
UNIMED SURGICAL COATED ELECTROSURGICAL ELECTRODES (K132224)Unimed Surgical Products, Inc.2013-10-08
ESTECH COBRA(R) GENESIS BIPOLAR CLAMP (K133017)Estech, Inc.2013-10-07
ENSEAL G2 TISSUE SEALER, STRAIGHT JAW, ENSEAL G2 TISSUE SEALER, CURVED JAW, ENSEAL TRIO TISSUE SEALER, 3 MM CURVED JAW, (K131435)Ethicon Endo-Surgery, LLC2013-10-03
DEROYAL ELECTROSURGICAL PENCIL, ROCKER STYLE WITHOUT HOLSTER, DEROYAL ELECTROSURGICAL PENCIL, BUTTON STYLE WITHOUT HOLST (K132199)Deroyal Industries, Inc.2013-10-03
GENII ARC SMART ARGON PROBE (K130983)Genii, Inc.2013-09-26
PELLEVE GLIDESAFE 10MM, 15MM & 20MM HANDPIECE, PELLEVE S5 - IEC (K132665)Ellman International, Inc.2013-09-25
ELECTROSURGICAL GENERATOR (K130760)Beijing Jinhengwei Technology Development Co., Ltd.2013-09-16
THERMAGE CPT SYSTEM (K132431)Solta Medical, Inc.2013-09-06
SINGLE USE GROUNDING PAD (K132136)Lccs Products Limited2013-09-06
BAYLIS MEDICAL RF PERFORATION PROBE V2.0 (K132374)Baylis Medical Company, Inc.2013-08-30
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