510(k) Report

FDA applicant

Meddev Corp.

Sunnyvale, CA3 decisions1994–20152 recalls

FDA records 3 decisions for Meddev Corp. (Sunnyvale, CA) from 1994 to 2015: 3 510(k) clearances. All are in product code MML (Weights, Eyelid, External). Its devices cite 2 predicates, 1 of them its own earlier devices. 2 recalls are linked to its devices.

FDA’s records also spell it “Meddev Corporation”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, ophthalmic panel, where it files most

How often FDA has decided Meddev Corp.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2015

2015: 1
2007high 1 (2015) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

2in 2024

2024: 2
2007high 2 (2024) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Meddev Corp. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • MMLWeights, Eyelid, External3decisions

Whose devices does it build on?

Its devices cite 2 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 times; 1 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K150986Contour Eyelid Weight Implants, ThinProfile Eyelid Weight ImplantsMeddev Corporation · 20151cites it
  • K011740Contour Design Gold Eyelid Implant, Model Contour Design (Series 3000)Meddev Corp. · 20011cites it
  • K940974Eyeclose External Eyelid WeightsMeddev Corp. · 19941cites it

What has FDA decided for it lately?

  • K150986Contour Eyelid Weight Implants, ThinProfile Eyelid Weight ImplantsMeddev Corporation · 20152 recalls
  • K011740Contour Design Gold Eyelid Implant, Model Contour Design (Series 3000)Meddev Corp. · 2001
  • K940974Eyeclose External Eyelid WeightsMeddev Corp. · 1994

All 2 as Meddev Corp. →The one decision as Meddev Corporation →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K150986Brand Name: Contour Product Name: Contour Gold Eyelid Weight Model/Catalog Number…Jul 12, 2024Class II
  • K150986Brand Name: Contour Product Name: Contour Gold Eyelid Weight Model/Catalog Number…Jul 12, 2024Class II

Other applicant names beginning “Meddev”

FDA records each applicant name separately; these may or may not be the same firm.

Meddev International Corp. 4