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GEI

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

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RecordFirmDate
Viveve System 2.0 (K190422)Viveve Medical2019-06-12
Argon Handset (K191064)New Deantronics Taiwan , Ltd.2019-06-12
Erbe ESU Model VIO 3 with Accessories (K190823)Erbe Elektromedizin GmbH2019-05-22
Soniquence RF Generator and Soniquence Electrodes (K183611)Soniquence, LLC2019-05-22
Electrosurgical accessory (K183126)New Deantronics Taiwan , Ltd.2019-05-08
Medline Electrocautery Pencil (K190643)Medline Industries, Inc.2019-05-06
Codman Electrosurgical Generator, Foot Pedal (K183526)Kls Martin GmbH + Co. KG2019-04-11
Erbe APCapplicators (K183445)Erbe Elektromedizin GmbH2019-04-04
Aquas Probes (K190168)Genicon, Inc.2019-03-14
Renuvion/J-Plasma Precise Handpiece, Renuvion/J-Plasma Precise Open handpieces, Renuvion/J-Plasma Precise Open handpieces (K183610)Bovie Medical Corporation2019-03-12
Caiman 5 Maryland (K183180)Aesculap, Inc.2019-03-12
EasyInstruments (K182013)Agency For Medical Innovations GmbH2019-03-11
Empower RF Catheter (K183240)Broncus Medical, Inc.2019-02-22
Laparoscopic Curved Spatula Electrode, Retractable, Aspiration Hole, 28cm ; Laparoscopic Wire J-Hook Electrode, Retractable, Aspiration Hole, 28cm ; Laparoscopic Wire L-Hook Electrode, Retractable, Aspiration Hole, 28cm; Laparoscopic Wire L-Hook Electrode, Retractable, Aspiration, 36cm ; Laparoscopic Flat L-Hook Electrode, Retractable, Aspiration Hole, 28cm ; Laparoscopic Straight Spatula Electrode, Hollow, 28cm ; Laparoscopic Curved Spatula Electrode, Hollow, 28cm; Laparoscopic Wire J (K183594)New Deantronics Taiwan , Ltd.2019-02-19
Aurora Evacuator (K190075)Rebound Therapeutics2019-02-12
FLOW 90 Wand (K183346)ArthroCare Corporation2019-01-24
VIVA combo RF System (K183538)Starmed Co., Ltd.2019-01-17
SIRA RFA Electrosurgical Device (K181071)Innoblative Designs, Inc.2019-01-16
OsteoCool RF Ablation System (K182497)Medtronic Sofamor Danek USA, Inc.2019-01-15
SafeAir Telescopic Smoke Pencil (K182354)Lina Medical Aps2018-12-14
BTL-FR2000 (K180359)BTL Industries, Inc.2018-12-13
Medline Cautery Electrode (SILICONE) (K182812)Medline Industries, Inc.2018-12-12
Mygen V-1000 RF System (K180999)RF Medical Co., Ltd.2018-12-11
LUTRONIC GENIUS Radiofrequency System (K180945)Lutronic Corporation2018-12-10
Device Electrosurgical Generator ESG-150 (K182587)Olympus Winter & Ibe GmbH2018-11-29
Codman Electrosurgical Irrigator, Codman Electrosurgical Irrigator Interconnecting Cable (K182801)Integra LifeSciences Corporation2018-11-27
HEMOSTATIX MODEL P8400 DISPOSABLE HANDLE, HEMOSTATIX MODEL P8400 DISPOSABLE BLADES (K183009)Hemostatix Medical Technologies, LLC2018-11-26
Valleylab Smoke Evacuation Rocker Switch Pencil , Valleylab Telescoping Smoke Evacuation Rocker Switch Pencil (K182772)Covidien2018-11-19
Voyant Maryland Fusion Device (K182653)Applied Medical Resources Corp.2018-11-14
BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider (K182451)Covidien, LLC2018-11-06
TempSure System (K182365)Cynosure, Inc.2018-10-24
Percuvance Percutaneous Surgical System (K181852)Teleflexmedical, Inc.2018-10-12
SCARLET SRF (K180872)VIOL Co., Ltd.2018-10-11
Voyant Electrosurgical Generator (K182244)Applied Medical Resources Corp.2018-10-11
InMode RF System (K182325)Inmode MD , Ltd.2018-09-26
NICO Myriad (K182340)Nico Corporation2018-09-20
EUSRA RF Electrode (K181249)Starmed Co., Ltd.2018-09-04
PlasmaBlade X 3.0S, PlasmaBlade X 4.0 (K181257)Medtronic Advanced Energy2018-08-02
Disposable Electrosurgical Pencils (K170369)Cathay Manfacturing Corp.2018-07-19
PINXEL-RF system (K180654)Rohrer Aesthetics, LLC2018-07-13
THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type X, THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type X, THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type X (K180575)Olympus Medical Systems Corp.2018-07-12
LigaSure Maryland Jaw Thoracic Sealer/Divider One-step Sealing, Nano-coated (K181085)Covidien2018-06-21
Valleylab FT10 Energy Platform, Valleylab FX8 FX Series Energy Platform (K181389)Covidien2018-06-19
Pollogen Legend System (K173503)Pollogen, Ltd.2018-06-11
InMode System with Fractora3D/3D-90 Applicators (K180189)Inmode MD , Ltd.2018-06-01
ENSEAL X1 Tissue Sealer, Curved Jaw, Articulating 37 cm Shaft Length; ENSEAL X1 Tissue Sealer, Curved Jaw, Articulating 45 cm Shaft Length (K180403)Ethicon Endo-Surgery, LLC2018-05-23
DiLumen Endolumenal Interventional Scissors (DiLumen Is) (K173405)Lumendi, LLC2018-05-22
Irrigation Tubing Bipolar Cord Set (K180908)New Deantronics Taiwan , Ltd.2018-05-18
Endopath Electrosurgery Probe Plus II (K180031)Ethicon Endo-Surgery, LLC2018-05-07
AMBIENT Super MULTIVAC 50 Wand with Integrated Finger Switches (K180848)ArthroCare Corporation2018-05-01
ESG-300, APU-300, Pressure Reducer, MAPC Probes (K180200)Olympus Winter & Ibe GmbH2018-04-26
THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type S, THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type S, THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (K172610)Olympus Medical Systems Corp.2018-04-17
Voyant Open Fusion Device (K180699)Applied Medical Resources Corporation2018-04-13
Aurora Evacuator (K180372)Rebound Therapeutics2018-04-09
Medline Cautery Electrode (PTFE) (K173889)Medline Industries, Inc.2018-04-09
Viveve RF System, Secure (K180584)Viveve, Inc.2018-04-06
Bipolar Micro-Coagulation Forceps (K172368)Gunter Bissinger Medizintechnik GmbH2018-04-05
star RF Electrode, VIVA RF Electrode (K172012)Starmed Co., Ltd.2018-03-14
LigaSure Exact Dissector, Nano-coated (K173281)Covidien2018-03-02
Sutter CURIS RF Generator (K171869)Sutter Medizintechnik GmbH2018-02-23
BOWA Neutral Electrodes (K173877)Bowa-Electronics GmbH & Co. KG2018-02-15
Voyant 5mm Fusion Device (K172624)Applied Medical Resources Corporation2018-02-13
Disposable Endoscopic Surgical Instrument, Reusable Endoscopic Surgical Instrument (K171825)Hunan Handlike Minimally Invasive Surgery Co., Ltd.2018-02-13
Stryker 90-S Max SERFAS Energy Probe (K171391)Stryker2018-01-26
ThermiX Temperature Control Radiofrequency System, Accessories - RF Electrodes (K173582)Thermigen, L.L.C2018-01-17
Thermage CPT System and Accessories (K173759)Solta Medical2018-01-08
Vivaer ARC Stylus (K172529)Aerin Medical, Inc.2017-12-05
LAP-iX (K173112)Sejong Medical Co., Ltd.2017-11-21
ENSEAL X1 Tissue Sealer, Straight Jaw, 25 cm Shaft Length, ENSEAL X1 Tissue Sealer, Straight Jaw, 37 cm Shaft Length, ENSEAL X1 Tissue Sealer, Curved Jaw, 25 cm Shaft Length,ENSEAL X1 Tissue Sealer, Curved Jaw, 37 cm Shaft Length,ENSEAL X1 Tissue Sealer, Curved Jaw, 45 cm Shaft Length (K172580)Ethicon Endo-Surgery, LLC2017-11-20
Reprocessed LigaSure Blunt Tip Laparoscopic Sealer/Divider (K172856)Stryker Sustainability Solutions2017-11-16
Bipolar applicator CELON ProCurve V (K172535)Olympus Winter & Ibe GmbH2017-11-16
Valleylab FX8 Electrosurgical Platform (K172757)Covidien, LLC2017-11-02
gi-4000 Electrosurgical Generator (K172805)United States Endoscopy Group, Inc.2017-10-23
X-SURGE (K171752)Genicon, Inc.2017-10-17
CELFIRM (K172023)VIOL Co., Ltd.2017-10-13
InMode RF System (K171593)Inmode MD , Ltd.2017-10-10
HelixAR Electrosurgical Generator with Argon Beam Coagulation, HelixAR Mobile Pedestal (K172671)Conmed Corporation2017-10-04
iSurg (K170054)Jaco, LLC Dba Macan Manufacturing and Bna Burz North America2017-10-02
Single Use Micro Electrode (Brass with gold plated shaft); Single Use Micro Electrode (Stainless Steel shaft) (K163442)Modern Medical Equipment Manufacturing Limited2017-09-28
Thermage FLX System and Accessories (K170758)Solta Medical2017-09-22
TempSure (K171262)Cynosure, Inc.2017-09-22
Pollogen Legend+ System (K171359)Pollogen, Ltd.2017-09-13
Minimally Invasive Sealer (MIS) Flex, Minimally Invasive Sealer (MIS) Flex Mini (K170381)Medtronic Advanced Energy2017-09-07
Stryker Integrated Bipolar Cord and Tubing Sets (K172367)Stryker Instruments2017-08-22
Monopolar Single Use Laparoscopic Instrument (K171523)Getsch+Hiller Medizintechnik GmbH2017-08-22
GA-B, GA-C, GA-E, GA-I, GA-S, GA-W3A, GA-F3A, GA-IL, GA-SL, GA-W3B, GA-F1A (K171707)Gowoonsesang Cosmetics Co., Ltd.2017-08-08
Epix Electrosurgical Probe with Smoke Evacuation (K171684)Applied Medical Resources Corporation2017-08-07
AUTOCON III 400 (K171717)KARL STORZ Endoscopy-America, Inc.2017-08-02
SECRET RF (K170325)Ilooda Co,., Ltd.2017-06-13
BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider (K171066)Covidien, LLC2017-06-08
PK AIM (K170908)Gyrus Acmi, Inc.2017-05-19
Active Needle Endoscopic Treatment (ANET) Electrosurgical Applicator (K170990)Spiration, Inc.2017-05-11
Thermi Reusable Non-invasive RF Electrode (K171094)Thermgen, L.L.C2017-05-08
Snowden-Pencer MicroLap 3mm Laparoscopic Instruments (K163615)Carefusion 2200, Inc.2017-05-04
Surgi Max Ultra (K170107)Elliquence, LLC2017-05-03
Bovie J-Plasma Precise FLEX Handpiece (K170777)Bovie Medical Corporation2017-05-01
LigaSure Maryland Jaw Sealer/Divider One-step Sealing, Nano-coated (K170869)Covidien2017-04-21
Cut-Vac Lighted Smoke Evacuation Electrosurgical Pencil (K170721)Precision Surgical, LLC2017-04-21
joimax Endovapor 2 (K170358)Joimax GmbH2017-04-21
SlimShape System (K163415)Syneron Medical, Ltd.2017-04-20
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