Megadyne Medical Products, Inc.
Megadyne Medical Products, Inc. holds FDA 510(k) medical device clearances, first cleared 1990, most recent 2024, with 20 FDA device recalls on record.
Top product codes for Megadyne Medical Products, Inc.
FDA recalls by Megadyne Medical Products, Inc.
10 most recent of 20- Z-2250-2024 — 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 Product Description: Reusable Patient Return Electrode, Mega Soft, Dual Cord, Adult, For Patients Weighing over 25lbs. (11.4kg), 117cm Long x 51cm Wide x 1.25cm Thick Component: No
- Z-2249-2024 — 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 Description: Reusable Patient Return Electrode, Mega Soft, Single Cord, Adult, For Patients Weighing over 25lbs (11.4Kg), 117cm Long x 51cm Wide x 1.25cm Thick Component: No
- Z-2248-2024 — 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 Patient Return Electrode, Mega 2000, Adult, For Patients Weighing over 25lbs. (11.4Kg), 91cm Long x 51cm Wide Component: No
- Z-1920-2024 — 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.
- Z-0597-2024 — Product Code 0845, MEGADYNE MEGA SOFT Universal Patient Return Electrode, Reusable Patient Return Electrode
- Z-0600-2024 — Product Code 0848, MEGADYNE MEGA SOFT Universal Plus Dual Patient Return Electrode, Reusable Patient Return Electrode, Mega Soft Universal Dual Plus
- Z-0599-2024 — Product Code 0847, MEGADYNE MEGA SOFT Universal Plus Patient Return Electrode, Reusable Patient Return Electrode, Mega Soft Universal Plus
- Z-0598-2024 — Product Code 0846, MEGADYNE MEGA SOFT Universal Dual Patient Return Electrode, Reusable Patient Return Electrode, Mega Soft Universal Dual Cord
- Z-2257-2023 — 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 Code 004325 (Suction Coagulator, Handswitching, 12 Fr, 6 inch (15.24cm)), and Product Code 0041BN (Suction Coagulator, Handswitching, 10 Fr, 6 inch (15.24cm), Bulk Non Sterile)
- Z-2000-2023 — MEGADYNE MEGA SOFT Universal Plus Dual Patient Return Electrode. used during electrosurgery
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Megadyne Medical Products, Inc.
- K233644 — Megadyne Patient Return Electrode Pad - Universal Dual (model 0846), Megadyne Patient Return Electrode Pad - Universal Plus (model 0847), Megadyne Patient Return Electrode Pad - Universal Dual Plus (model 0848)
- K213696 — ETHICON Megadyne Electrosurgical Generator
- K200250 — Megadyne Smoke Evacuator, Megadyne Filter, Megadyne Fluid Trap, Megadyne Connect Cable, 1 m and 2.1 m, Megadyne RF Sensor
- K193145 — Ethicon Megadyne Electrosurgical Generator, Bipolar Footswitch
- K191328 — Megadyne Foot Switch
- K141587 — E-Z CLEAR SMOKE EVACUATION ELECTROSURGICAL PENCIL; CLEAR NOZZLE EXTENTION, ULPA FILTER, CHARCOAL FILTER, ADAPTER
- K133726 — MEGA SOFT UNIVERSAL PATIENT RETURN ELECTRODE
- K080741 — MEGA SOFT REUSABLE PATIENT RETURN ELECTRODE
- K081791 — E-Z CLEAN ELECTROSURGICAL ELECTRODE
- K072559 — SUCTION COAGULATOR
- K050579 — MEGA POWER ELECTROSURGICAL GENERATOR
- K050102 — E-Z PEN, REUSEABLE HANDSWITCHING PENCIL
- K040699 — LAPAROSCOPIC ELECTRODE, REUSABLE INDICATOR SHAFT (LERIS)
- K031285 — MEGA 2000 SOFT DUAL CORD PATIENT RETURN ELECTRODE PAD
- K021077 — MEGA 2000 SOFT PATIENT RETURN ELECTRODE PAD
- K982826 — MEGA 2000
- K973346 — UNCOATED ELECTROSURGICAL ELECTRODE
- K972273 — TBD
- K965054 — PENCIL
- K953479 — BIPOLAR FORCEPS
- K946237 — ELECTROSURGICAL DEVICE, CUTTING AND COAGULATION AND ACCESSORIES
- K951035 — BIPOLAR FORCEPS
- K943055 — ELECTROSURGICAL CUTTING AND COAGULATING DEVICE AND ACCESSORIES
- K945898 — ELECTROSURGICAL DEVICE, CUTTING AND COAGULATION AND ACCESSORIES
- K942306 — IRRIGATION/ASPIRATION INSTRUMENT
- K942489 — ELECTROSURGICAL CUTTING & COAGULATION DEVICE
- K925478 — ELECTROSURGICAL ELECTRODE
- K933085 — GOODMAN BANDAGE
- K932102 — ELECTROSURGICAL ELECTRODE
- K926306 — FOOT CONTROL PENCIL
- K922002 — SUCTION IRRIGATION CAUTERY PROBE
- K913141 — MEGA MYELOGRAM KIT
- K912597 — ELECTROSURGICAL ELECTRODE
- K913473 — E-Z CLEAN ELECTRODE
- K912337 — ELECTROSURGICAL CUT & COAGULATION DEVICE & ACCESS
- K913281 — E-Z CLEAN LAPAROSCOPIC ELECTRODE
- K911586 — GENERAL HOSPITAL TUBING CLAMP (NON-ELECTRIC)
- K910089 — MEGA LUMBAR PUNCTURE KIT
- K910963 — THOROCENTESIS KIT
- K905060 — ELECTRODE EXTENDER
- K910362 — TRACHEOSTOMY CARE KIT
- K910363 — MEGA DRESSING CHANGE KIT
- K910365 — WOUND CLOSURE KIT
- K910366 — MEGA GENERAL PURPOSE INSTRUMENT KIT
- K910369 — INCISION AND DRAINAGE KIT
- K910361 — SUTURE REMOVAL KIT
- K910368 — MEGA LACERATION KIT
- K904808 — ELECTROSURGICAL PENCIL
- K903302 — ELECTRODE, ELECTROSURGERY
- K903006 — ELECTROSURGICAL BIPOLAR FORCEPS
Data sourced from openFDA. This site is unofficial and independent of the FDA.