Panels › General, Plastic Surgery › Product code GEI · Class 2
Electrosurgical, Cutting & Coagulation & Accessories
Regulation 878.4400
47510(k)s in 12 months (2,321 all time)
18recalls in 12 months (644 all time)
601recalls that name a 510(k)
Top companies in GEI
| Company | 510(k)s | Recalls |
|---|---|---|
| ArthroCare Corporation | 86 | 5 |
| Conmed Corporation | 25 | 53 |
| Valleylab | 69 | 0 |
| Megadyne Medical Products, Inc. | 32 | 31 |
| Covidien | 41 | 14 |
| Carefusion 2200, Inc. | 2 | 45 |
| Stryker | 9 | 35 |
| Conmedcorp | 43 | 0 |
| Gyrus Acmi, Inc. | 21 | 20 |
| Bovie Medical | 21 | 15 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 7, 2023 | Stryker Corporation Disposable Spetzler-Malis Bipolar forceps, 23CM SM DISP BAYONET 0.5MM TIP, Catalog Number 6760-230-005 Open, Classified |
GEI | K121426 |
| Nov 7, 2023 | Stryker Corporation Disposable Spetzler-Malis Bipolar forceps, 20CM SM DISP BAYONET 0.5MM TIP, Catalog Number 6760-200-005 Open, Classified |
GEI | K121426 |
| Nov 7, 2023 | Stryker Corporation Disposable Spetzler-Malis Bipolar forceps, 18CM SM DISP BAYONET 1.5MM TIP, Catalog Number 6760-180-015 Open, Classified |
GEI | K121426 |
| Nov 7, 2023 | Stryker Corporation Disposable Spetzler-Malis Bipolar forceps, 18CM SM DISP BAYONET 0.5MM TIP, Catalog Number 6760-180-005 Open, Classified |
GEI | K110924 K121426 |
| Nov 2, 2023 | Maquet Cardiovascular, LLC Vasoview 6 Pro (VV6) - Endoscopic Vessel Harvesting System, Model VH-2400 printed on outer label, inner label and IFU, outer box artwork for Vasoview Hemopro 2 (HP2). Open, Classified |
GEI | K091733 |
| Jul 28, 2023 | Megadyne Medical Products, Inc. MEGADYNE Suction Coagulators, Product Code 004125 (Suction Coagulator, Handswitching, 10 Fr, 6 inch (15.24cm)), Product Code 004225 (Suction Coagulator, Handswitching, 8 Fr, 6 inch (15.24cm), Product Open, Classified |
GEI | K072559 |
| Jun 30, 2023 | Megadyne Medical Products, Inc. MEGADYNE MEGA SOFT Universal Dual Patient Return Electrode. used during electrosurgery Open, Classified |
GEI | K133726 |
| Jun 30, 2023 | Megadyne Medical Products, Inc. MEGADYNE MEGA SOFT Universal Plus Dual Patient Return Electrode. used during electrosurgery Open, Classified |
GEI | K133726 |
| Jun 30, 2023 | Megadyne Medical Products, Inc. MEGADYNE MEGA SOFT Universal Plus Patient Return Electrode. used during electrosurgery Open, Classified |
GEI | K133726 |
| Jun 30, 2023 | Megadyne Medical Products, Inc. MEGADYNE MEGA SOFT Universal Patient Return Electrode. used during electrosurgery Open, Classified |
GEI | K133726 |
| Jun 30, 2023 | Megadyne Medical Products, Inc. MEGADYNE MEGA SOFT Pediatric Patient Return Electrode. used during electrosurgery Open, Classified |
GEI | K080741 |
| Jun 30, 2023 | Megadyne Medical Products, Inc. MEGADYNE MEGA SOFT Dual Reusable Patient Return Electrode. used during electrosurgery Open, Classified |
GEI | K031285 |
| Jun 30, 2023 | Megadyne Medical Products, Inc. MEGADYNE MEGA SOFT Reusable Patient Return Electrode. used during electrosurgery Open, Classified |
GEI | K021077 |
| Jun 30, 2023 | Megadyne Medical Products, Inc. MEGADYNE MEGA 2000 Patient Return Electrode. used during electrosurgery Open, Classified |
GEI | K982826 |
| May 5, 2023 | Aesculap Implant Systems LLC Aesculap Caiman Articulating D5/360MM - An electrosurgical cutting and coagulation device for cutting/coagulation/ablation during endoscopic (including laparoscopic, arthroscopic) surgery, and may in Open, Classified |
GEI | K183180 |
| Apr 7, 2023 | Solta Medical Inc thermage THERMAGE CPT SYSTEM REF TG-2B *** Solta Medical, Inc.
thermage RF GENERATOR REF TG-2B *** Solta Medical, Inc.
Dermatologic and general surgical procedures for electrocoagulation and hemosta Open, Classified |
GEI | K173759 |
| Apr 4, 2023 | Maquet Cardiovascular, LLC VASOVIEW HEMOPRO, OUS, Endoscopic Vessel Harvesting System, Model Number C-VH-3000-W Open, Classified |
GEI | K153194 |
| Apr 4, 2023 | Maquet Cardiovascular, LLC VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System, Model Number C-VH-4000 Open, Classified |
GEI | K101274 |
| Apr 4, 2023 | Maquet Cardiovascular, LLC VASOVIEW HEMOPRO Endoscopic Vessel Harvesting System, Model Number C-VH-3500 Open, Classified |
GEI | K153194 |
| Jan 19, 2023 | Maquet Cardiovascular, LLC Hemopro 2 with Vasoshield, Model VH-4001 Open, Classified |
GEI | K101274 |
| Dec 9, 2022 | ConMed Corporation Foot Controlled Electrosurgical Suction Coagulator, Electrosurgical Suction Coagulator 10FR, Catalog Number 130187 Terminated |
GEI | K033003 |
| Dec 3, 2022 | Carefusion 2200 Inc CareFusion V. Mueller CUSHING MICRO BIPOLAR FORCEPS 0.7MM TIP, OVERALL LENGTH 6" (150MM), REF F-52000 Open, Classified |
GEI | K213386 |
| Dec 3, 2022 | Carefusion 2200 Inc CareFusion V. Mueller Neuro/Spine TITANIUM BAYONET INSULATED IRRIGATING BIPOLAR FORCEPS 0.5MM TIP, ANGLED-UP, FINE OVERALL LENGTH 8-3/4" (225MM), REF F-5304 Open, Classified |
GEI | K213386 |
| Dec 3, 2022 | Carefusion 2200 Inc CareFusion V. Mueller TITANIUM BAYONET INSULATED IRRIGATING BIPOLAR FORCEPS 1.0MM TIP, STR, MED, INSULATED OVERALL LENGTH 8-3/4" (225MM), REF F-5303 Open, Classified |
GEI | K213386 |
| Dec 3, 2022 | Carefusion 2200 Inc CareFusion V. Mueller TITANIUM BAYONET IRRIGATING BIPOLAR FORCEPS INSULATED STRAIGHT FINE, 0.5MM TIP OVERALL LENGTH 8-3/4" (225MM), REF F-5302 Open, Classified |
GEI | K213386 |
| Dec 3, 2022 | Carefusion 2200 Inc CareFusion V. Mueller TITANIUM BAYONET INSULATED IRRIGATING BIPOLAR FORCEPS 1.5MM TIP, STRAIGHT, INSULATED OVERALL LENGTH 8-3/4" (225MM), REF F-5301 Open, Classified |
GEI | K213386 |
| Dec 3, 2022 | Carefusion 2200 Inc CareFusion V. Mueller Neuro/Spine TITANUIM BIPOLAR FORCEPS STRAIGHT, 0.25MM TIP OVERALL LENGTH 6" (150MM) , REF F-5128 Open, Classified |
GEI | K213386 |
| Dec 3, 2022 | Carefusion 2200 Inc CareFusion V. Mueller TITANIUM BAYONET BIPOLAR FORCEPS, 0.5MM TIP, ANGLED-UP FINE OVERALL LENGTH 8-3/4" (225MM), REF F-5127 Open, Classified |
GEI | K213386 |
| Dec 3, 2022 | Carefusion 2200 Inc CareFusion V. Mueller TITANIUM BAYONET BIPOLAR FORCEPS, 1.0MM TIP, STRAIGHT MEDIUM OVERALL LENGTH 8-3/4" (225MM), REF F-5126 Open, Classified |
GEI | K213386 |
| Dec 3, 2022 | Carefusion 2200 Inc CareFusion V. Mueller TITANIUM BAYONET BIPOLAR FORCEPS, STRAIGHT, FINE 0.5MM TIP OVERALL LENGTH 8-3/4" (225MM), REF F-5125 Open, Classified |
GEI | K213386 |
| Dec 3, 2022 | Carefusion 2200 Inc CareFusion V. Mueller TITANIUM BAYONET BIPOLAR FORCEPS, 1.5MM TIP, STRAIGHT STANDARD, 8-3/4" (225MM), REF F-5124 Open, Classified |
GEI | K213386 |
| Dec 3, 2022 | Carefusion 2200 Inc CareFusion V. Mueller ROUND HANDLE BAYONET BIPOLAR FORCEPS 1.5MM TIP OVERALL LENGTH 10-1/2" (265MM), REF F-5073 Open, Classified |
GEI | K213386 |
| Dec 3, 2022 | Carefusion 2200 Inc CareFusion V. Mueller ROUND HANDLE BAYONET BIPOLAR FORCEPS, 1.0MM TIP OVERALL LENGTH 10-1/2" (265MM), REF F-5069 Open, Classified |
GEI | K213386 |
| Dec 3, 2022 | Carefusion 2200 Inc CareFusion V. Mueller ROUND HANDLE BAYONET BIPOLAR FORCEPS 0.7MM TIP OVERALL LENGTH 10-1/2" (265MM), REF F-5067 Open, Classified |
GEI | K213386 |
| Dec 3, 2022 | Carefusion 2200 Inc CareFusion V. Mueller ROUND HANDLE BAYONET BIPOLAR FORCEPS 1.0MM TIP OVERALL LENGTH 9-1/2" (240MM), REF F-5061 Open, Classified |
GEI | K213386 |
| Dec 3, 2022 | Carefusion 2200 Inc CareFusion V. Mueller TITANIUM ROUND HANDLE BAYONET BIPOLAR FORCEPS 1.5MM TIP OVERALL LENGTH 10-1/2" (265MM), REF F-5022 Open, Classified |
GEI | K213386 |
| Dec 3, 2022 | Carefusion 2200 Inc CareFusion V. Mueller TITANIUM ROUND HANDLE BAYONET BIPOLAR FORCEPS,1.0MM TIP OVERALL LENGTH 10-1/2" (265MM), REF F-5018 Open, Classified |
GEI | K213386 |
| Dec 3, 2022 | Carefusion 2200 Inc CareFusion V. Mueller TITANIUM ROUND HANDLE BAYONET BIPOLAR FORCEPS 0.7MM TIP OVERALL LENGTH 10-1/2" (265MM), REF F-5016 Open, Classified |
GEI | K213386 |
| Dec 3, 2022 | Carefusion 2200 Inc CareFusion V. Mueller TITANIUM ROUND HANDLE BAYONET BIPOLAR FORCEPS 1.5MM TIP OVERALL LENGTH 9-1/2" (240MM), REF F-5014 Open, Classified |
GEI | K213386 |
| Dec 3, 2022 | Carefusion 2200 Inc CareFusion V. Mueller Neuro/Spine TITANIUM ROUND HANDLE BAYONET BIPOLAR FORCEPS, 1.0MM TIP OVERALL LENGTH 9-1/2" (240MM), REF F-5010 Open, Classified |
GEI | K213386 |
| Dec 3, 2022 | Carefusion 2200 Inc CareFusion V. Mueller TITANIUM ROUND HANDLE BAYONET BIPOLAR FORCEPS, 0.7MM TIP OVERALL LENGTH 9-1/2" (240MM) , REF F-5008 Open, Classified |
GEI | K213386 |
| Dec 3, 2022 | Carefusion 2200 Inc CareFusion V. Mueller euro/Spine TITANIUM ROUND HANDLE BAYONET BIPOLAR FORCEPS 1.5MM TIP OVERALL LENGTH 8-1/2" (215MM), REF F-5006 Open, Classified |
GEI | K213386 |
| Dec 3, 2022 | Carefusion 2200 Inc CareFusion V. Mueller TITANIUM ROUND HANDLE BAYONET BIPOLAR FORCEPS, 1.0MM TIP OVERALL LENGTH 8-1/2" (215MM), REF F-5002 Open, Classified |
GEI | K213386 |
| Dec 3, 2022 | Carefusion 2200 Inc CareFusion V. Mueller ADSON BIPOLAR FORCEPS 1.0MM TIP, INSULATED OVERALL LENGTH 4-3/4" (120MM), REF F-3015 Open, Classified |
GEI | K213386 |
| Dec 3, 2022 | Carefusion 2200 Inc Carefusion V. Mueller ADSON BIPOLAR FORCEPS 1.0MM TIP OVERALL LENGTH 4-3/4" (120MM), REF F-3010 Open, Classified |
GEI | K213386 |
| Dec 3, 2022 | Carefusion 2200 Inc Carefusion V. Mueller Neuro/Spine JEWELERS BIPOLAR FORCEPS 0.4MM TIP, CURVED, # 7 OVERALL LENGTH 4-3/4" (120MM), REF F-3007 Open, Classified |
GEI | K213386 |
| Dec 3, 2022 | Carefusion 2200 Inc Carefusion V. Mueller JEWELERS BIPOLAR FORCEPS 0.4MM TIP, STRAIGHT OVERALL LENGTH 4" (100MM), REF F-3000 Open, Classified |
GEI | K213386 |
| Dec 3, 2022 | Carefusion 2200 Inc Carefusion V. Mueller" CUSHING BAYONET BIPOLAR FORCEPS, 2.0MM TIP, INSULATED OVERALL LENGTH 7-1/2" (190MM), REF F-2004 Open, Classified |
GEI | K213386 |
| Dec 3, 2022 | Carefusion 2200 Inc Carefusion V. Mueller CUSHING BIPOLAR FORCEPS 1.5MM TIP, INSULATED OVERALL LENGTH 7" (180MM), REF F-2002 Open, Classified |
GEI | K213386 |
| Dec 3, 2022 | Carefusion 2200 Inc Carefusion V. Mueller HARDY BAYONET IRRIGATING BIPOLAR FORCEPS INSULATED, 0.5MM TIP OVERALL LENGTH 8-1/2" (215MM), REF F-1335 Open, Classified |
GEI | K213386 |
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