Med-Dyne G536S
by Med-Dyne
Med-Dyne G536S is a Class II device made by Med-Dyne, cleared under FDA 510(k) K080112 on 20 Jun 2008 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 00817497020615), active as of 22 Oct 2026. One FDA recall is linked to it.
Active
510(k)
Valid until
No expiry
FDA recalls
1 ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00817497020615 | Date24 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK080112 | Date20 Jun 2008 | StatusActive |
Official records
- AccessGUDID record 00817497020615
- FDA 510(k) database K080112
Across registries
- FDA 510(k) K080112 decided 20 Jun 2008 Active
- FDA GUDID UDI-DI 00817497020615 listed 24 Sep 2016 Listed
Recalls
-
- Ongoing Z-2553-2019
The electrode lead connector has a protruding conductor beyond insulation of approximately 0.1 mm.
Timeline
- Cleared FDA 510(k) K080112
- Listed FDA GUDID 00817497020615
- Recall initiated FDA recalls Z-2553-2019
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Med-Dyne
- Generic name
- Electrocardiographic lead set, single-use
- Model / reference
- G536S
- Primary DI / UDI-DI
- 00817497020615
- 510(k) Number
- FDA product code
- DSA
- GMDN term
- Electrocardiographic lead set, single-use
- Device class
- Class II
- Regulation number
- 870.2900
- GUDID distribution status
- In Commercial Distribution
- Size
- Length — 36 Inch
Similar devices in this category
Other devices filed under Electrocardiographic lead set, single-use.