510(k) Report

FDA applicant

Bio Med Sciences, Inc.

Bethlehem, PA10 decisions1991–20020 recalls

FDA records 10 decisions for Bio Med Sciences, Inc. (Bethlehem, PA) from 1991 to 2002: 10 510(k) clearances. Most are in product codes MDA (Elastomer, Silicone, For Scar Management) and MGP (Dressing, Wound And Burn, Occlusive). Its devices cite 7 predicates, 5 of them its own earlier devices. No 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, general and plastic surgery panel, where it files most

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

FDA decisions per year

No FDA decision for Bio Med Sciences, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Bio Med Sciences, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • MDAElastomer, Silicone, For Scar Management7decisions
  • MGPDressing, Wound And Burn, Occlusive2decisions
  • FRODressing, Wound, Drug1decision

Whose devices does it build on?

Its devices cite 7 predicates; 5 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 9 times; 5 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.

  • K982036Silon Scar StripsBio Med Sciences, Inc. · 19982cite it
  • K912032Silon (TM) Transparent Wound DressingBio Med Sciences, Inc. · 19912cite it
  • K923150Silon Transparent Wound DressingsBio Med Sciences, Inc. · 19922cite it
  • K023136Oleeva FabricBio Med Sciences, Inc. · 20021cites it
  • K932214Silon Silicone Gel SheetBio Med Sciences, Inc. · 19941cites it
  • K002109Oleeva FoamBio Med Sciences, Inc. · 20001cites it

What has FDA decided for it lately?

  • K023136Oleeva FabricBio Med Sciences, Inc. · 2002
  • K002109Oleeva FoamBio Med Sciences, Inc. · 2000
  • K990042Silon Dual-DressBio Med Sciences, Inc. · 1999
  • K982036Silon Scar StripsBio Med Sciences, Inc. · 1998
  • K952546Silon Silicone Textile CompositeBio Med Sciences, Inc. · 1995
  • K946362Silon Silicone Foam SheetingBio Med Sciences, Inc. · 1995
  • K945892Silon (R) Silicone Thermoplastic SheetingBio Med Sciences, Inc. · 1995
  • K932214Silon Silicone Gel SheetBio Med Sciences, Inc. · 1994

All 10 as Bio Med Sciences, Inc. →