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Megadyne

by Megadyne Medical Products, Inc. 21 variants

Ref 1450J

Megadyne (1450J) is a device classified as Class I in the EU and Class II in the US made by Megadyne Medical Products, Inc., registered in EUDAMED on 24 Oct 2025 (Basic UDI-DI 0614559a00008BX), cleared under FDA 510(k) K050579 on 24 Mar 2005 and listed in FDA GUDID since 4 Sep 2018 (UDI-DI 10614559105276), active as of 22 Oct 2026. One FDA recall is linked to it.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None ongoing

1 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K050579

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0614559a00008BX Basic UDI-DI 10614559105276UDI-DIDate24 Oct 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number10614559105276 UDI-DI Date4 Sep 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK050579 Date24 Mar 2005DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0614559a00008BX registered 24 Oct 2025 Active
  • FDA 510(k) K050579 decided 24 Mar 2005 Active
  • FDA GUDID UDI-DI 10614559105276 listed 4 Sep 2018 Listed

Recalls

1 recall · FDA

    • Terminated Z-2792-2018 FDA Class II initiated 15 May 2018

    If two devices are plugged into the same channel/port in the generator, both devices activate. If one device is left laying on the patient, the result could be burning of the patient.

Timeline

4 dated events

  1. Cleared FDA 510(k) K050579
  2. Recall initiated FDA recalls Z-2792-2018
  3. Listed FDA GUDID 10614559105276
  4. Registered EUDAMED 0614559a00008BX

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Generic name
Foot-switch, electrical
Device name
MEGADYNE Footswitch
Model / Ref / Catalog
1450J
Primary DI / UDI-DI
10614559105276
Basic UDI-DI
0614559a00008BX
Direct marketing DI
10614559105276
510(k) Number
FDA product code
GEI
EMDN code
Z12010980 Electrosurgery instruments - hardware accessories
GMDN term
Foot-switch, electrical
Device class
Class I EUDAMED
Class II GUDID
Regulation number
878.4400
EU registration type
Standard device
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Manufacturer details

EUDAMED SRN
US-MF-000017046
Authorised representative
Johnson & Johnson Medical GmbH DE-AR-000007712

Similar devices in this category

Other devices filed under ELECTROSURGERY INSTRUMENTS - HARDWARE ACCESSORIES.

Other devices from Megadyne Medical Products, Inc.

See all devices from Megadyne Medical Products, Inc. →

Properties

  • Prescription use
  • Serial number
Other properties (23, all answered No)