FDA device listing

ELMED

FDA device listing 1726448875 · ELMED, INC.

Key facts

Proprietary names ELMED
Owner/operator ELMED, INC.
Owner/operator number 1412854
Product codes FZS
Device names FZS - Curette, Surgical, General Use
Device class Class I
Classification regulations (21 CFR) 878.4800
Review panels General & Plastic Surgery
Registered establishments ELMED, INC.
Establishment registrations 1412854
FEI numbers 1412854
Establishment operations Repackager/Relabeler
Registration valid through 2026

At a glance

  • 1–9 Registered establishments listing this device
  • None listed Premarket submission listed

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device listings

Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.

Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database

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