Company ยท US
Megadyne Medical Products, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1990 to 2024. Name variants (Inc, Corp, punctuation) are merged.
50510(k) clearances (0 in 12 months)
31recalls (0 in 12 months)
31recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 63 |
| FYD | Apparatus, Exhaust, Surgical | 2 |
| JOS | Electrode, Electrosurgical | 2 |
| KDD | Kit, Surgical Instrument, Disposable | 2 |
| LRO | General Surgery Tray | 2 |
| BYY | Tube, Aspirating, Flexible, Connecting | 1 |
| FMI | Needle, Hypodermic, Single Lumen | 1 |
| FMJ | Manometer, Spinal-Fluid | 1 |
| GCJ | Laparoscope, General & Plastic Surgery | 1 |
| HGI | Electrocautery, Gynecologic (And Accessories) | 1 |
| JOH | Tube Tracheostomy And Tube Cuff | 1 |
| JOL | Catheter And Tip, Suction | 1 |
| KGY | Bag, Intestine | 1 |
| MCY | Wound Dressing Kit | 1 |
| MCZ | Suture Removal Kit | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 12, 2024 | K233644 | Megadyne Patient Return Electrode Pad - Universal Dual (model 0846), Megadyne Patient Return Electrode Pad - Universal P Megadyne Medical Products, Inc. | GEI |
| Jan 21, 2022 | K213696 | ETHICON Megadyne Electrosurgical Generator Megadyne Medical Products, Inc. | GEI |
| Jun 26, 2020 | K200250 | Megadyne Smoke Evacuator, Megadyne Filter, Megadyne Fluid Trap, Megadyne Connect Cable, 1 m and 2.1 m, Megadyne RF Senso Megadyne Medical Products, Inc. | FYD |
| Mar 24, 2020 | K193145 | Ethicon Megadyne Electrosurgical Generator, Bipolar Footswitch Megadyne Medical Products, Inc. | GEI |
| Jul 26, 2019 | K191328 | Megadyne Foot Switch Megadyne Medical Products, Inc. | FYD |
| Feb 18, 2015 | K141587 | E-Z CLEAR SMOKE EVACUATION ELECTROSURGICAL PENCIL;CLEAR NOZZLE EXTENTION, ULPA FILTER, CHARCOAL FILTER, ADAPTER Megadyne Medical Products, Inc. | GEI |
| Jan 24, 2014 | K133726 | MEGA SOFT UNIVERSAL PATIENT RETURN ELECTRODE Megadyne Medical Products, Inc. | GEI |
| Dec 16, 2008 | K080741 | MEGA SOFT REUSABLE PATIENT RETURN ELECTRODE Megadyne Medical Products, Inc. | GEI |
| Oct 21, 2008 | K081791 | E-Z CLEAN ELECTROSURGICAL ELECTRODE Megadyne Medical Products, Inc. | GEI |
| Oct 5, 2007 | K072559 | SUCTION COAGULATOR Megadyne Medical Products, Inc. | GEI |
| Mar 24, 2005 | K050579 | MEGA POWER ELECTROSURGICAL GENERATOR Megadyne Medical Products, Inc. | GEI |
| Feb 1, 2005 | K050102 | E-Z PEN, REUSEABLE HANDSWITCHING PENCIL Megadyne Medical Products, Inc. | GEI |
| Jun 4, 2004 | K040699 | LAPAROSCOPIC ELECTRODE, REUSABLE INDICATOR SHAFT (LERIS) Megadyne Medical Products, Inc. | GEI |
| May 19, 2003 | K031285 | MEGA 2000 SOFT DUAL CORD PATIENT RETURN ELECTRODE PAD Megadyne Medical Products, Inc. | GEI |
| Apr 17, 2002 | K021077 | MEGA 2000 SOFT PATIENT RETURN ELECTRODE PAD Megadyne Medical Products, Inc. | GEI |
| Nov 6, 1998 | K982826 | MEGA 2000 Megadyne Medical Products, Inc. | GEI |
| Nov 7, 1997 | K973346 | UNCOATED ELECTROSURGICAL ELECTRODE Megadyne Medical Products, Inc. | GEI |
| Jul 8, 1997 | K972273 | TBD Megadyne Medical Products, Inc. | GEI |
| Jan 24, 1997 | K965054 | PENCIL Megadyne Medical Products, Inc. | GEI |
| Oct 12, 1995 | K953479 | BIPOLAR FORCEPS Megadyne Medical Products, Inc. | GEI |
| Jun 7, 1995 | K946237 | ELECTROSURGICAL DEVICE, CUTTING AND COAGULATION AND ACCESSORIES Megadyne Medical Products, Inc. | GEI |
| Apr 7, 1995 | K951035 | BIPOLAR FORCEPS Megadyne Medical Products, Inc. | GEI |
| Dec 21, 1994 | K943055 | ELECTROSURGICAL CUTTING AND COAGULATING DEVICE AND ACCESSORIES Megadyne Medical Products, Inc. | GEI |
| Dec 13, 1994 | K945898 | ELECTROSURGICAL DEVICE, CUTTING AND COAGULATION AND ACCESSORIES Megadyne Medical Products, Inc. | GEI |
| Sep 23, 1994 | K942306 | IRRIGATION/ASPIRATION INSTRUMENT Megadyne Medical Products, Inc. | GCJ |
| Jul 25, 1994 | K942489 | ELECTROSURGICAL CUTTING & COAGULATION DEVICE Megadyne Medical Products, Inc. | GEI |
| Jun 27, 1994 | K925478 | ELECTROSURGICAL ELECTRODE Megadyne Medical Products, Inc. | HGI |
| Dec 23, 1993 | K933085 | GOODMAN BANDAGE Megadyne Medical Products, Inc. | KGY |
| Sep 23, 1993 | K932102 | ELECTROSURGICAL ELECTRODE Megadyne Medical Products, Inc. | GEI |
| Feb 5, 1993 | K926306 | FOOT CONTROL PENCIL Megadyne Medical Products, Inc. | GEI |
| Sep 2, 1992 | K922002 | SUCTION IRRIGATION CAUTERY PROBE Megadyne Medical Products, Inc. | GEI |
| Oct 17, 1991 | K913141 | MEGA MYELOGRAM KIT Megadyne Medical Products, Inc. | FMI |
| Sep 6, 1991 | K913473 | E-Z CLEAN ELECTRODE Megadyne Medical Products, Inc. | GEI |
| Sep 6, 1991 | K912597 | ELECTROSURGICAL ELECTRODE Megadyne Medical Products, Inc. | GEI |
| Aug 16, 1991 | K913281 | E-Z CLEAN LAPAROSCOPIC ELECTRODE Megadyne Medical Products, Inc. | GEI |
| Aug 16, 1991 | K912337 | ELECTROSURGICAL CUT & COAGULATION DEVICE & ACCESS Megadyne Medical Products, Inc. | GEI |
| Jul 2, 1991 | K911586 | GENERAL HOSPITAL TUBING CLAMP (NON-ELECTRIC) Megadyne Medical Products, Inc. | BYY |
| Jun 20, 1991 | K910963 | THOROCENTESIS KIT Megadyne Medical Products, Inc. | JOL |
| Jun 20, 1991 | K910089 | MEGA LUMBAR PUNCTURE KIT Megadyne Medical Products, Inc. | FMJ |
| Apr 12, 1991 | K905060 | ELECTRODE EXTENDER Megadyne Medical Products, Inc. | JOS |
| Apr 8, 1991 | K910362 | TRACHEOSTOMY CARE KIT Megadyne Medical Products, Inc. | JOH |
| Mar 28, 1991 | K910369 | INCISION AND DRAINAGE KIT Megadyne Medical Products, Inc. | KDD |
| Mar 28, 1991 | K910366 | MEGA GENERAL PURPOSE INSTRUMENT KIT Megadyne Medical Products, Inc. | KDD |
| Mar 28, 1991 | K910365 | WOUND CLOSURE KIT Megadyne Medical Products, Inc. | LRO |
| Mar 28, 1991 | K910363 | MEGA DRESSING CHANGE KIT Megadyne Medical Products, Inc. | MCY |
| Mar 27, 1991 | K910361 | SUTURE REMOVAL KIT Megadyne Medical Products, Inc. | MCZ |
| Mar 18, 1991 | K910368 | MEGA LACERATION KIT Megadyne Medical Products, Inc. | LRO |
| Jan 4, 1991 | K904808 | ELECTROSURGICAL PENCIL Megadyne Medical Products, Inc. | GEI |
| Oct 2, 1990 | K903302 | ELECTRODE, ELECTROSURGERY Megadyne Medical Products, Inc. | JOS |
| Sep 20, 1990 | K903006 | ELECTROSURGICAL BIPOLAR FORCEPS Megadyne Medical Products, Inc. | GEI |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 3, 2024 | Megadyne 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 |
GEI | K031285 |
| Jul 3, 2024 | Megadyne 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 |
GEI | K021077 |
| Jul 3, 2024 | Megadyne 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 |
GEI | K080741 |
| Jun 6, 2024 | Megadyne 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 |
GEI | K080741 |
| Dec 26, 2023 | Megadyne 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 |
GEI | K233644 |
| Dec 26, 2023 | Megadyne Medical Products, Inc. Product Code 0847, MEGADYNE MEGA SOFT Universal Plus Patient Return Electrode, Reusable Patient Return Electrode, Mega Soft Universal Plus Open, Classified |
GEI | K233644 |
| Dec 26, 2023 | Megadyne 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 |
GEI | K233644 |
| Dec 26, 2023 | Megadyne Medical Products, Inc. Product Code 0845, MEGADYNE MEGA SOFT Universal Patient Return Electrode, Reusable Patient Return Electrode Open, Classified |
GEI | K133726 |
| 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 |
| Aug 13, 2018 | Megadyne Medical Products, Inc. MegaPower Electrosurgical Generator, Product code 1000, GTIN 10614559103715 Terminated |
GEI | K050579 |
| Mar 7, 2014 | Megadyne Medical Products, Inc. Hand Control 12FR Suction Coagulator with 10 ft cord and holster, Sterile, Disposable, Model Number 0043-25, packaged Tyvek polyester peel pouch, 25 pouches per box.
This device is intended to conduc Terminated |
GEI | K072559 |
| Aug 27, 2013 | Megadyne Medical Products, Inc. E-Z Clean Disposable Laparoscopic Electrode Model Number 0100L and 0100LS. Expiration dates of 05/2018 to 07/2018. Sterile. RX ONLY. This product is packaged individually in a chevron Tyvek - polyes Terminated |
GEI | K913281 |
| Dec 3, 2009 | Megadyne Medical Products, Inc. E-Z CLEAN Non Stick Cautery Tip. Label reads in part: "MEGADYNE 11506 SOUTH STATE STREET DRAPER, UTAH 84020 USA***CAT/REF 0029M E-Z CLEAN NON STICK CAUTERY TIP***STERILE *** Expiration Date: 2104-07* Terminated |
GEI | K081791 |
| Apr 19, 2006 | Megadyne Medical Products, Inc Button Switch Electrosurgical Pencil with Holster Terminated |
GEI | K965054 |
| Apr 19, 2006 | Megadyne Medical Products, Inc Rocker Switch Electrosurgical Pencil with Holster Terminated |
GEI | K965054 |
| Apr 19, 2006 | Megadyne Medical Products, Inc Button Switch Electrosurgical Pencil with Stainless Steel Tip and Holster Terminated |
GEI | K965054 |
| Apr 19, 2006 | Megadyne Medical Products, Inc Rocker Switch Electrosurgical Pencil with Stainless Steel Tip and Holster Terminated |
GEI | K965054 |
| Apr 19, 2006 | Megadyne Medical Products, Inc Button Switch Electrosurgical Pencil with Modified E-Z Clean Tip and Holster Terminated |
GEI | K965054 |
| Apr 19, 2006 | Megadyne Medical Products, Inc Rocker Switch Electrosurgical Pencil with Modified E-Z Clean Tip and Holster Terminated |
GEI | K965054 |
| Apr 19, 2006 | Megadyne Medical Products, Inc Button Switch Electrosurgical Pencil with E-Z Clean Tip and Holster Terminated |
GEI | K965054 |
| Apr 19, 2006 | Megadyne Medical Products, Inc Rocker Switch Electrosurgical Pencil with E-Z Clean Tip Terminated |
GEI | K965054 |
| Jan 30, 2003 | Megadyne Medical Products, Inc Megadyne MegaTip, Modified E-Z Clean Non Stick Cautery Tip, CAT/REF 0600M, Single Use Only, STERILE Terminated |
GEI | K943055 |
| Jan 30, 2003 | Megadyne Medical Products, Inc Megadyne MegaTip, E-Z Clean Non Stick Cautery Tip, CAT/REF 0600, Single Use Only, STERILE Terminated |
GEI | K943055 |