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GEI

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

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RecordFirmDate
ClosureFast™ Endovenous Radiofrequency Ablation Catheter (K223488)Medtronic, Inc.2023-03-23
HF Surgery Generator 400KHZ (K230194)Richard Wolf Medical Instruments Corporation2023-03-22
Retraction, CWM-910T, APOLEX Tite (K222709)Chungwoo Co., Ltd.2023-03-21
HPR45i (K220725)F Care Systems USA, LLC2023-03-20
Renuvion® APR Handpiece (K223262)Apyx Medical Corporation2023-02-23
ATTIVA (K220505)Italian Engineering S.R.L.2023-02-09
Duoblade (K220996)Cnc Technologies2023-02-03
LigaSure™ XP Maryland Jaw Sealer/Divider (K223158)Covidien, LLC2023-01-23
HF-cables (resusable) (K221522)Olympus Winter & Ibe GmbH2023-01-19
Plasma IQ (K223222)Neauvia North America, Inc.2023-01-17
NeoGen PSR System (K221873)Energist Limited2023-01-12
da Vinci E-200 Electrosurgical Generator (K223039)Intuitive Surgical2022-11-28
Electrosurgical Pencil (OBS-Db, OBS-Dr, OBS-Dc, OBS-Df, OBS-Di, OBS-De); Electrosurgical Pencil (OBS-Dt, OBS-Dd, OBS-Ds, OBS-Dl, OBS-Da) (K221815)Baisheng Medical Co., Ltd.2022-11-23
TempSure System (K223292)Cynosure, LLC2022-11-23
Supra Non-Stick Bipolar Forceps (K213042)Guenter Bissinger Medizintechnik GmbH2022-11-17
truSculpt iD (K223110)Cutera, Inc.2022-11-03
NEUROMARK System (K222032)Neurent Medical2022-10-26
WavelinQ™ Generator (K222793)C.R. Bard, Inc.2022-10-17
LUDWIG Electrosurgical Device (K221574)Aesthetics Biomedical2022-10-16
Voyant Maryland Fusion device with Single-Step Activation (EB212, EB213, EB214) (K222284)Applied Medical Resources Corporation2022-10-14
The Oligio (K221989)Wontech Co., Ltd.2022-10-13
Apyx One Console (K221830)Apyx Medical Corporation2022-10-11
Kogent Disposable Copper Forceps, Kogent Disposable Irrigating Copper Forceps, Kogent Disposable Illuminating Copper Forceps (K213610)Katalyst Surgical, LLC2022-10-07
Surtron 80 D, Surtron 160, Surtron 200, Surtron Flash 160 HF, Surtron 400 HP (K220138)Led Spa2022-10-05
MTX-C1 (K212561)Ilooda Co,., Ltd.2022-09-27
CellFX System (K213674)Pulse Biosciences, Inc.2022-09-22
OptaBlate RF Generator, OptaBlate Probes, OptaBlate Microinfuser Infusion Device (K221074)Stryker Corporation2022-09-16
Ellusa Reusable Bipolar Cable (K222429)Ellusa, LLC2022-09-09
Ellusa Reusable Neutral Plates (K222425)Ellusa, LLC2022-09-08
Soniquence Reusable 3 Button Fingerswitch Wand (K212222)Soniquence, LLC2022-09-02
Mygen M-3004 RF Generator M-3004 (K221277)RF Medical Co., Ltd.2022-09-02
CellFX System (K222075)Pulse Biosciences, Inc.2022-09-02
Ambient HipVac 50 Wand with Integrated Finger Switches, RF20000 COBLATION System, WEREWOLF COBLATION System, WEREWOLF+ COBLATION System (K220563)ArthroCare Corporation2022-09-01
Beamer AVEO Electrosurgical Generator, Beamer AVEO Argon Module, Beamer AVEO Cart, Beamer AVEO Wired Foot Pedal, Beamer AVEO Argon Pressure Reducer (K214058)Conmed Corporation2022-08-26
CellFX® System (K221671)Pulse Biosciences, Inc.2022-08-01
RhinAer® Stylus (FG1393) (K221907)Aerin Medical, Inc.2022-07-29
Beamer AVEO FILTER INTEGRATED ARGON PROBE 1.8mm x 160 cm, Beamer AVEO FILTER INTEGRATED ARGON PROBE 1.8 mm X 320 cm, Beamer AVEO FILTER INTEGRATED ARGON PROBE 2.3 mm X 230 cm, Beamer AVEO FILTER INTEGRATED ARGON PROBE 2.3 mm x 320 cm, Beamer AVEO FILTER INTEGRATED ARGON SIDEFIRE PROBE 2.3 mm x 230 cm (K221945)Conmed Corporation2022-07-28
Renuvion APR Handpiece (K220970)Apyx Medical Corporation(Formerly Bovie Medical Corporation)2022-07-15
AGNES (K203013)Agnes Medical Co., Ltd.2022-07-14
truSculpt iD (K221407)Cutera, Inc.2022-07-13
AgeJet (K212472)Triworks Group Srl2022-07-07
CiRX Single use electrosurgical pencil with non-coated and coated electrode (K213786)Ningbo Shun YE Medical Company, Ltd.2022-06-27
maxmorespine Bipolar Electrodes (K211173)Hoogland Spine Products, GmbH2022-06-23
SYLFIRM X (K213612)VIOL Co., Ltd.2022-06-23
ACUTRON (K211000)Ilooda Co,., Ltd.2022-06-09
SILKRO (K210084)Hironic Co., Ltd.2022-06-03
Remanufactured LigaSure Exact Dissector, Without Nano-coating (LF2019) (K220481)Stryker Sustainability Solutions2022-05-25
Renuvion Dermal Handpiece, Renuvion Dermal System (K211652)Apyx Medical Corporation (Formerly Bovie Medical Corporation2022-05-25
Plasmage System (K202106)Brera Medical, Inc.2022-04-06
PLEXR PLUS (K210693)Gmv S.R.L.2022-03-22
TempSure System (K212891)Cynosure, LLC2022-03-18
Single Use Hand Switch Monopolar Forceps with Smoke Evacuation, Single Use Hand Switch Bipolar Forceps with Smoke Evacuation, Single Use Hand Switch Monopolar Forceps, Single Use Hand Switch Bipolar Forceps (K210315)Modern Medical Equipment Manufacturing, Ltd.2022-03-17
Unify Multifunction Energy Platform, CleanSeal Vessel Sealers, Unify Bipolar Resection Cables, Unify Wireless FootSwitch, Unify Cart (K213354)Conmed Corporation2022-03-11
BTL-785W (K211639)BTL Industries, Inc.2022-03-07
ReNew Disposable Scissor Tips (K213127)Microline Surgical, Inc.2022-03-02
Cool-tip RF Ablation System E Series (K203150)Covidien, LLC2022-02-25
ArtiSential Laparoscopic Instruments-Electrodes (K220384)Livsmed, Inc.2022-02-24
YandR System, VoluDerm Handpiece, VoluDerm Tips (K220124)Pollogen, Ltd.2022-02-17
Soniquence Reusable Neutral Plate (K220071)Soniquence, LLC2022-02-03
Viveve 2.0 System (K213814)Viveve, Inc.2022-02-02
HotDog Warming Mattress + Return Electrode (K210727)Augustine Temperature Management, LLC2022-02-01
ShinEvac Smoke Evacuation Pencil (K213317)Shining World Health Care Co., Ltd.2022-01-28
ETHICON Megadyne Electrosurgical Generator (K213696)Megadyne Medical Products, Inc.2022-01-21
Medline Universal Grounding Pad (K212093)Medline Industries, Inc.2022-01-14
BTL-899A (K213344)BTL Industries, Inc.2022-01-05
Olympus PK Electrosurgical Instruments, PK J-hook, PK Spatula, PK Needle (K213831)Gyrus Acmi, Inc.2022-01-04
Single Use Electrosurgical Knife with Fluid Pump System (K211172)Micro-Tech (Nanjing) Co., Ltd.2021-12-17
Voyant Fine Fusion Device (EB230) (K202818)Applied Medical2021-12-16
Profound Matrix (K211217)Candela Corporation2021-12-16
Plasma IQ (K212329)Neauvia North America, Inc.2021-12-09
AURORA Evacuator +Coag (K203745)Rebound Therapeutics2021-12-02
Virtue RF (K211562)ShenB Co., Ltd.2021-11-23
Reverso (K212107)Intelis Instruments , Ltd.2021-11-10
Disposable Monopolar Laparoscopic Tips and Reusable Handles (K211019)Dannik, LLC2021-10-28
The Alma Opus System, Colibri Applicator and Tips (K201520)Alma Lasers, Inc.2021-10-27
Titan Manufacturing Bipolar Forceps (K213386)Titan Manufacturing, Inc.2021-10-25
Ultrasonic Surgical & Electrosurgical Generator (K210488)Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.2021-10-25
Neuromark System (K212666)Neurent Medical2021-10-22
Single Use Irrigation bipolar cable (K211170)Modern Medical Equipment Manufacturing, Ltd.2021-10-19
LAP-iX (K200639)Sejong Medical Co., Ltd.2021-09-29
POWERSEAL Curved Jaw Sealer and Divider, Double Action (K212643)Olympus Surgical Technologies America2021-09-27
Viveve System, Viveve 2.0 System (K212678)Viveve Medical, Inc.2021-09-14
CoolSeal Trinity (30 cm shaft), CoolSeal Trinity (37 cm shaft), CoolSeal Trinity (44 cm shaft) (K211579)Bolder Surgical, LLC2021-09-07
CellFX System (K211444)Pulse Biosciences, Inc.2021-08-25
Disposable Monopolar Laparoscopic Shafts and Reusable Handles (K210569)Dannik, LLC2021-08-16
Venclose digiRF Generator with Maven Catheter, Venclose Maven System, Venclose digiRF Generator, Venclose Maven Catheter (K211806)Venclose, Inc.2021-08-03
Soniquence Reusable Bipolar Cable (K211946)Soniquence, LLC2021-07-16
InMode RF Pro System (K210492)Inmode MD , Ltd.2021-07-12
BTL-899 FP (K211107)BTL Industries, Inc.2021-07-09
Werewolf+ Coblation System, Werewolf+ Controller, Werewolf Fastseal 6.0 Hemostasis Wand (K210423)ArthroCare Corporation2021-06-24
Electrosurgical Generator ESG-400, Foot Switches, POWERSEAL Curved Jaw Sealer and Divider, Double Action (K203682)Olympus Winter & Ibe GmbH2021-05-17
MicroFrance Monopolar and Bipolar Electrosurgical Instruments (K210942)Integra Microfrance2021-05-14
CoolSeal Trinity (30 cm shaft, 37 cm shaft, and 44 cm shaft) (K203183)Bolder Surgical, LLC2021-05-06
CoolSeal Reveal (K203640)Bolder Surgical, LLC2021-05-06
ArtiSential Laparoscopic Instruments-Electrodes (K203580)Livsmed, Inc.2021-04-30
Electrosurgical Generator ESG-410, Foot Switches, PK Cutting Forceps (K203277)Olympus Winter & Ibe GmbH2021-04-28
VIVACE Electrosurgical Device (K193070)ShenB Co., Ltd.2021-04-26
Edge Insulated Blade Electrode (K210338)Covidien, LLC2021-04-15
Star RF Electrode, VIVA RF Electrode (K203795)Starmed Co., Ltd.2021-04-01
LigaSure Exact Dissector, Nano-coated (K202917)Covidien, LLC2021-03-23
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