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Megadyne Medical Products, Inc.

FDA Regulatory Profile

Summary

Total Recalls
20 (16 Class I)
510(k) Clearances
50
Inspections
5
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2249-2024Class IBrand Name: MEGADYNE" MEGA SOFT" Reusable Patient Return Electrode Product Name: MEGADYNE" MEGA SOFJune 17, 2024
Z-2250-2024Class IBrand Name: MEGADYNE" MEGA SOFT" Dual Reusable Patient Return Electrode Product Name: MEGADYNE" MEGJune 17, 2024
Z-2248-2024Class IBrand Name: MEGADYNE" MEGA 2000" Patient Return Electrode Product Name: MEGADYNE" MEGA 2000" PatienJune 17, 2024
Z-1920-2024Class IMEGADYNE MEGA SOFT Pediatric Patient Return Electrode. Reusable Patient Return Electrode for patientMay 8, 2024
Z-0599-2024Class IProduct Code 0847, MEGADYNE MEGA SOFT Universal Plus Patient Return Electrode, Reusable Patient RetuDecember 8, 2023
Z-0598-2024Class IProduct Code 0846, MEGADYNE MEGA SOFT Universal Dual Patient Return Electrode, Reusable Patient RetuDecember 8, 2023
Z-0597-2024Class IProduct Code 0845, MEGADYNE MEGA SOFT Universal Patient Return Electrode, Reusable Patient Return ElDecember 8, 2023
Z-0600-2024Class IProduct Code 0848, MEGADYNE MEGA SOFT Universal Plus Dual Patient Return Electrode, Reusable PatientDecember 8, 2023
Z-2257-2023Class IIMEGADYNE Suction Coagulators, Product Code 004125 (Suction Coagulator, Handswitching, 10 Fr, 6 inch June 15, 2023
Z-1997-2023Class IMEGADYNE MEGA SOFT Pediatric Patient Return Electrode. used during electrosurgeryJune 1, 2023
Z-1994-2023Class IMEGADYNE MEGA 2000 Patient Return Electrode. used during electrosurgeryJune 1, 2023
Z-1998-2023Class IMEGADYNE MEGA SOFT Universal Patient Return Electrode. used during electrosurgeryJune 1, 2023
Z-1995-2023Class IMEGADYNE MEGA SOFT Reusable Patient Return Electrode. used during electrosurgeryJune 1, 2023
Z-2000-2023Class IMEGADYNE MEGA SOFT Universal Plus Dual Patient Return Electrode. used during electrosurgeryJune 1, 2023
Z-1999-2023Class IMEGADYNE MEGA SOFT Universal Plus Patient Return Electrode. used during electrosurgeryJune 1, 2023
Z-1996-2023Class IMEGADYNE MEGA SOFT Dual Reusable Patient Return Electrode. used during electrosurgeryJune 1, 2023
Z-2001-2023Class IMEGADYNE MEGA SOFT Universal Dual Patient Return Electrode. used during electrosurgeryJune 1, 2023
Z-2792-2018Class IIMegaPower Electrosurgical Generator, Product code 1000, GTIN 10614559103715May 15, 2018
Z-1151-2014Class IIHand Control 12FR Suction Coagulator with 10 ft cord and holster, Sterile, Disposable, Model Number February 27, 2014
Z-2097-2013Class IIE-Z Clean¿ Disposable Laparoscopic Electrode Model Number 0100L and 0100LS. Expiration dates of 05/August 7, 2013

Recent 510(k) Clearances

K-NumberDeviceDate
K233644Megadyne Patient Return Electrode Pad - Universal Dual (model 0846), Megadyne Patient Return ElectroJuly 12, 2024
K213696ETHICON Megadyne Electrosurgical GeneratorJanuary 21, 2022
K200250Megadyne Smoke Evacuator, Megadyne Filter, Megadyne Fluid Trap, Megadyne Connect Cable, 1 m and 2.1 June 26, 2020
K193145Ethicon Megadyne Electrosurgical Generator, Bipolar FootswitchMarch 24, 2020
K191328Megadyne Foot SwitchJuly 26, 2019
K141587E-Z CLEAR SMOKE EVACUATION ELECTROSURGICAL PENCIL;CLEAR NOZZLE EXTENTION, ULPA FILTER, CHARCOAL FILTFebruary 18, 2015
K133726MEGA SOFT UNIVERSAL PATIENT RETURN ELECTRODEJanuary 24, 2014
K080741MEGA SOFT REUSABLE PATIENT RETURN ELECTRODEDecember 16, 2008
K081791E-Z CLEAN ELECTROSURGICAL ELECTRODEOctober 21, 2008
K072559SUCTION COAGULATOROctober 5, 2007
K050579MEGA POWER ELECTROSURGICAL GENERATORMarch 24, 2005
K050102E-Z PEN, REUSEABLE HANDSWITCHING PENCILFebruary 1, 2005
K040699LAPAROSCOPIC ELECTRODE, REUSABLE INDICATOR SHAFT (LERIS)June 4, 2004
K031285MEGA 2000 SOFT DUAL CORD PATIENT RETURN ELECTRODE PADMay 19, 2003
K021077MEGA 2000 SOFT PATIENT RETURN ELECTRODE PADApril 17, 2002
K982826MEGA 2000November 6, 1998
K973346UNCOATED ELECTROSURGICAL ELECTRODENovember 7, 1997
K972273TBDJuly 8, 1997
K965054PENCILJanuary 24, 1997
K953479BIPOLAR FORCEPSOctober 12, 1995