ClearanceBrief
Panels › General, Plastic Surgery › Product code GEI · Class 2

Electrosurgical, Cutting & Coagulation & Accessories

Regulation 878.4400

46510(k)s in 12 months (2,320 all time)
18recalls in 12 months (644 all time)
601recalls that name a 510(k)
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Top companies in GEI

DateFirm and productCodeLinked 510(k)
Dec 10, 2024Microline Surgical, Inc.
Microscissor Tip (Disposable); Microline Catalog #: 3122.
Open, Classified
GEIK213127
Nov 13, 2024Stryker Corporation
Stryker Neptune SafeAir Smoke Evacuation Pencil Coated Push-Button, Bulk Non-sterile - Designed for general electrosurgical applications including cutting and coagulation and for removing smoke genera
Open, Classified
GEIK143145
Nov 13, 2024Stryker Corporation
Stryker Neptune SafeAir Smoke Evacuation Pencil Non coated 70 mm Blade Push-Button - Designed for general electrosurgical applications including cutting and coagulation and for removing smoke generate
Open, Classified
GEIK143145
Nov 13, 2024Stryker Corporation
Stryker Neptune SafeAir Smoke Evacuation Pencil, Coated, 70mm Blade, Push Button Switch - Designed for general electrosurgical applications including cutting and coagulation and for removing smoke gen
Open, Classified
GEIK143145
Nov 13, 2024Stryker Corporation
Stryker Neptune SafeAir Rocker-Switch Smoke Evacuation Pencil, Non-coated, 70mm - Designed for general electrosurgical applications including cutting and coagulation and for removing smoke generated b
Open, Classified
GEIK143145
Nov 13, 2024Stryker Corporation
Stryker Neptune SafeAir Smoke Evacuation Pencil Coated Rocker-Switch, Bulk Non-Sterile - Designed for general electrosurgical applications including cutting and coagulation and for removing smoke gene
Open, Classified
GEIK143145
Nov 13, 2024Stryker Corporation
Stryker Neptune SafeAir Rocker-Switch Smoke Evacuation Pencil, Coated, 70mm - Designed for general electrosurgical applications including cutting and coagulation and for removing smoke generated by el
Open, Classified
GEIK143145
Nov 13, 2024Bard Peripheral Vascular Inc
The EVSRF catheter is a sterile, single-use disposable medical device for endovenous radiofrequency ablation, a procedure in which a refluxing vein is thermally coagulated to permanently eliminate the
Open, Classified
GEIK160754
Nov 1, 2024Zimmer, Inc.
Saphena Medical Venapax XL- Endoscopic Vessel Harvesting System for use in minimally invasive surgery allowing access for vessel harvesting and is primarily indicated for patients undergoing endoscopi
Open, Classified
GEIK140603
Oct 30, 2024Olympus Corporation of the Americas
Olympus Electrosurgical Generator, Model Number ESG-410 (SEP) Version WA91327U
Open, Classified
GEIK231777
Oct 25, 2024Maquet Cardiovascular, LLC
VasoView HemoPro Endoscopic Vessel Harvesting System, Product Codes VH-3000-W and VH-3500
Open, Classified
GEIK052274
K153194
Sep 6, 2024MEDLINE INDUSTRIES, LP - Northfield
Medline Convenience kits labeled as: MUNCY PACK, Pack Number DYNJ03097D
Open, Classified
GEIK974279
Aug 8, 2024Olympus Corporation of the Americas
The Everest Bipolar Cutting Forceps are intended to be passed through a 5-mm or 10-mm cannula, depending on the model/outer diameter size of the forceps. Coagulation is achieved using electrosurgical
Open, Classified
GEIK023492
Aug 8, 2024Olympus Corporation of the Americas
The Everest Bipolar Cutting Forceps are intended to be passed through a 5-mm or 10-mm cannula, depending on the model/outer diameter size of the forceps. Coagulation is achieved using electrosurgical
Open, Classified
GEIK023492
Aug 8, 2024Olympus Corporation of the Americas
The Everest Bipolar Cutting Forceps are intended to be passed through a 5-mm or 10-mm cannula, depending on the model/outer diameter size of the forceps. Coagulation is achieved using electrosurgical
Open, Classified
GEIK023492
Jul 23, 2024Olympus Corporation of the Americas
ESG-410 Electrosurgical Generator- In conjunction with electrosurgical accessories intended for cutting and coagulation of tissue in open, laparoscopic , and endoscopic surgeries Model/Catalog Number:
Open, Classified
GEIK203277
Jul 11, 2024Maquet Cardiovascular, LLC
The VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System is designed for use in conjunction with the 7 mm Extended Length Endoscope. The Harvesting Cannula has four lumens which house the Endoscope,
Open, Classified
GEIK101274
Jul 11, 2024Maquet Cardiovascular, LLC
The VASOVIEW HEMOPRO Endoscopic Vessel Harvesting Systems is designed for use in conjunction with the 7 mm Extended Length Endoscope. The Harvesting Cannula has four lumens which house the Endoscope,
Open, Classified
GEIK153194
Jul 3, 2024Megadyne Medical Products, Inc.
Brand Name: MEGADYNE" MEGA SOFT" Dual Reusable Patient Return Electrode Product Name: MEGADYNE" MEGA SOFT" Dual Reusable Patient Return Electrode Model/Catalog Number: 0835 Software Version: N/A Produ
Open, Classified
GEIK031285
Jul 3, 2024Megadyne Medical Products, Inc.
Brand Name: MEGADYNE" MEGA SOFT" Reusable Patient Return Electrode Product Name: MEGADYNE" MEGA SOFT" Reusable Patient Return Electrode Model/Catalog Number: 0830 Software Version: N/A Product Descrip
Open, Classified
GEIK021077
Jul 3, 2024Megadyne Medical Products, Inc.
Brand Name: MEGADYNE" MEGA 2000" Patient Return Electrode Product Name: MEGADYNE" MEGA 2000" Patient Return Electrode Model/Catalog Number: 0800 Software Version: N/A Product Description: Reusable Pat
Open, Classified
GEIK080741
Jun 24, 2024Maquet Cardiovascular, LLC
The VASOVIEW HemoPro Endoscopic Vessel Harvesting Systems are designed for use in conjunction with the 7 mm Extended Length Endoscope. The Harvesting Cannula has four lumens which house the Endoscope,
Open, Classified
GEIK153194
Jun 24, 2024Maquet Cardiovascular, LLC
The VASOVIEW HemoPro 2 Endoscopic Vessel Harvesting System, labeled as the following: 1. VasoView Hemopro 2, Model Number: VH-4000. 2. VasoView Hemopro 2 with Vasoshield. Model Number: VH-4001. The
Open, Classified
GEIK101274
Jun 6, 2024Megadyne Medical Products, Inc.
MEGADYNE MEGA SOFT Pediatric Patient Return Electrode. Reusable Patient Return Electrode for patients weighing (0.8lb-50lb), (350g-22.7Kg), 66cm Long x 30.5cm Wide x 1.25cm. Electrosurgical use.
Open, Classified
GEIK080741
Apr 30, 2024Olympus Corporation of the Americas
POWERSEAL 5 mm, 44 cm, Curved Jaw Sealer and Divider, Double Action is indicated for use in general surgery and such surgical specialties as urologic, colorectal, bariatric, vascular, thoracic, and gy
Open, Classified
GEIK212643
Apr 30, 2024Olympus Corporation of the Americas
POWERSEAL 5 mm, 37 cm, Curved Jaw Sealer and Divider, Double Action is indicated for use in general surgery and such surgical specialties as urologic, colorectal, bariatric, vascular, thoracic, and gy
Open, Classified
GEIK212643
Apr 30, 2024Olympus Corporation of the Americas
POWERSEAL 5 mm, 23 cm, Curved Jaw Sealer and Divider, Double Action is indicated for use in general surgery and such surgical specialties as urologic, colorectal, bariatric, vascular, thoracic, and gy
Open, Classified
GEIK212643
Feb 20, 2024Olympus Corporation of the Americas
ESG PK CUTTING FORCEPS, 5MM, 33CM
Open, Classified
GEIK203277
Jan 12, 2024Maquet Cardiovascular, LLC
Vasoview Hemopro Endoscopic Vessel Harvesting System, model VH-3500.
Open, Classified
GEIK153194
Jan 12, 2024Maquet Cardiovascular, LLC
Vasoview Hemopro Endoscopic Vessel Harvesting System, model VH-3000-W .
Open, Classified
GEIK052274
Jan 3, 2024Covidien
Covidien Valleylab FT10, FT Series Energy Platform, REF: VLFT10GEN, DLVLFT10GEN, VLFT10GENZD
Open, Classified
GEIK191601
Dec 26, 2023Megadyne Medical Products, Inc.
Product Code 0848, MEGADYNE MEGA SOFT Universal Plus Dual Patient Return Electrode, Reusable Patient Return Electrode, Mega Soft Universal Dual Plus
Open, Classified
GEIK233644
Dec 26, 2023Megadyne Medical Products, Inc.
Product Code 0847, MEGADYNE MEGA SOFT Universal Plus Patient Return Electrode, Reusable Patient Return Electrode, Mega Soft Universal Plus
Open, Classified
GEIK233644
Dec 26, 2023Megadyne Medical Products, Inc.
Product Code 0846, MEGADYNE MEGA SOFT Universal Dual Patient Return Electrode, Reusable Patient Return Electrode, Mega Soft Universal Dual Cord
Open, Classified
GEIK233644
Dec 26, 2023Megadyne Medical Products, Inc.
Product Code 0845, MEGADYNE MEGA SOFT Universal Patient Return Electrode, Reusable Patient Return Electrode
Open, Classified
GEIK133726
Nov 7, 2023Stryker Corporation
Disposable Spetzler-Malis Bipolar forceps, 23CM SLM DISP BAYONET 1.5MM, Catalog Number 6780-230-015
Open, Classified
GEIK110924
K121426
Nov 7, 2023Stryker Corporation
Disposable Spetzler-Malis Bipolar forceps, 23CM SLM DISP BAYONET 1.0MM, Catalog Number 6780-230-010
Open, Classified
GEIK121426
Nov 7, 2023Stryker Corporation
Disposable Spetzler-Malis Bipolar forceps, 23CM SLM DISP BAYONET 0.5MM, Catalog Number 6780-230-005
Open, Classified
GEIK121426
Nov 7, 2023Stryker Corporation
Disposable Spetzler-Malis Bipolar forceps, 20CM SLM DISP BAYONET 1.5MM, Catalog Number 6780-200-015
Open, Classified
GEIK121426
Nov 7, 2023Stryker Corporation
Disposable Spetzler-Malis Bipolar forceps, 20CM SLM DISP BAYONET 1.0MM, Catalog Number 6780-200-010
Open, Classified
GEIK121426
Nov 7, 2023Stryker Corporation
Disposable Spetzler-Malis Bipolar forceps, 20CM SLM DISP BAYONET 0.5MM, Catalog Number 6780-200-005
Open, Classified
GEIK121426
Nov 7, 2023Stryker Corporation
Disposable Spetzler-Malis Bipolar forceps, 23CM IM DISP BAYONET 1.0MM TIP, Catalog Number 6770-230-010
Open, Classified
GEIK121426
Nov 7, 2023Stryker Corporation
Disposable Spetzler-Malis Bipolar forceps, 23CM IM DISP BAYONET 0.5MM TIP, Catalog Number 6770-230-005
Open, Classified
GEIK121426
Nov 7, 2023Stryker Corporation
Disposable Spetzler-Malis Bipolar forceps, 20CM IM DISP BAYONET 1.5MM TIP, Catalog Number 6770-200-015
Open, Classified
GEIK121426
Nov 7, 2023Stryker Corporation
Disposable Spetzler-Malis Bipolar forceps, 20CM IM DISP BAYONET 0.5MM TIP, Catalog Number 6770-200-005
Open, Classified
GEIK121426
Nov 7, 2023Stryker Corporation
Disposable Spetzler-Malis Bipolar forceps, 18CM IM DISP BAYONET 1.5MM TIP, Catalog Number 6770-180-015
Open, Classified
GEIK110924
K121426
Nov 7, 2023Stryker Corporation
Disposable Spetzler-Malis Bipolar forceps, 18CM IM DISP BAYONET 1.0MM TIP, Catalog Number 6770-180-010
Open, Classified
GEIK121426
Nov 7, 2023Stryker Corporation
Disposable Spetzler-Malis Bipolar forceps, 18CM IM DISP BAYONET 0.5MM TIP, Catalog Number 6770-180-005
Open, Classified
GEIK121426
Nov 7, 2023Stryker Corporation
Disposable Spetzler-Malis Bipolar forceps, 23CM SM DISP BAYONET 1.5MM TIP, Catalog Number 6760-230-015
Open, Classified
GEIK121426
Nov 7, 2023Stryker Corporation
Disposable Spetzler-Malis Bipolar forceps, 23CM SM DISP BAYONET 1.0MM TIP, Catalog Number 6760-230-010
Open, Classified
GEIK121426

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