510(k) Report

FDA applicant

Ceremed, Inc.

Los Angeles, CA20 decisions2004–20161 recall

FDA records 20 decisions for Ceremed, Inc. (Los Angeles, CA) from 2004 to 2016: 20 510(k) clearances. Most are in product codes KHJ (Polymer, Ent Synthetic-Polyamide (Mesh Or Foil…) and MTJ (Wax, Bone). Its devices cite 40 predicates, 22 of them its own earlier devices. 1 recall is linked to its devices.

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

FIG. A — Illustration, ear, nose and throat panel, where it files most

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

FDA decisions per year

2in 2016

2007: 12008: 42009: 12010: 12011: 12012: 22013: 12015: 12016: 2
2007high 4 (2008) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

1in 2023

2023: 1
2007high 1 (2023) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Ceremed, Inc. 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?

  • KHJPolymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)8decisions
  • MTJWax, Bone6decisions
  • KKYMaterial, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction4decisions
  • GWOPlate, Cranioplasty, Preformed, Alterable1decision
  • JEYPlate, Bone1decision

Whose devices does it build on?

Its devices cite 40 predicates; 22 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 33 times; 22 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.

  • K041363Aoc Bone WaxCeremed, Inc. · 20047cite it
  • K082491Ostene CT Soluble Bone Hemostasis Implant Material, Aoc CT, Aoc, Ostene, Osteotene & CereteneCeremed, Inc. · 20084cite it
  • K091636Ostene CT, Aoc CT, Osteotene, CereteneCeremed, Inc. · 20093cite it
  • K062280Ostene, Aoc, Osteotene, Ceretene, Cerepor, Aptene, Apatene and ActipasteCeremed, Inc. · 20063cite it
  • K081531Aoc Soluble Implant MaterialCeremed, Inc. · 20083cite it
  • K080507Aoc Porous Polyethylene, Aoc Porous Hdpe, Aoc Porous Polyethylene Surgical ImplantCeremed, Inc. · 20082cite it

What has FDA decided for it lately?

  • K161446Biopor Porous Polyethylene ImplantsCeremed, Inc. · 2016
  • K160988Biopor, AOC Porous Polyethylene, CereporCeremed, Inc. · 2016
  • K141880Biopor Aoc Porous Polyethylene, CereporCeremed, Inc. · 2015
  • K132198Adaptain, Adaptain Fastwrap, Envelock, BiowaiCeremed, Inc. · 2013
  • K122561Adaptain Fastwrap, Envelock, GraftainCeremed, Inc. · 2012
  • K120220Adaptain Soluble Implant MaterialCeremed, Inc. · 2012
  • K103047Ceretene Soluble Implant MaterialCeremed, Inc. · 2011
  • K102071Ostene CT, Aoc CT, Osteotene, CereteneCeremed, Inc. · 2010

All 20 as Ceremed, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K041363Baxter Ostene Hemostasis Material, Product Codes: a) 1503831, 3.5 G; b) 1503832, 2.5 G…Dec 6, 2023Class II