510(k) Report

FDA applicant

Philips Int'L B.V.

The Netherlands, NL11 decisions1985–19920 recalls

FDA records 11 decisions for Philips Int'L B.V. (The Netherlands, NL) from 1985 to 1992: 11 510(k) clearances. Most are in product codes FTC (Light, Ultraviolet, Dermatological) and ESD (Hearing Aid, Air-Conduction, Prescription). 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 Philips Int'L B.V.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Philips Int'L B.V. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Philips Int'L B.V. 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?

  • FTCLight, Ultraviolet, Dermatological9decisions
  • ESDHearing Aid, Air-Conduction, Prescription2decisions

What has FDA decided for it lately?

  • K920134Philips 41 Series RainbowPhilips Int'L B.V. · 1992
  • K920142Philips M60 SeriesPhilips Int'L B.V. · 1992
  • K852348Philips Solarium HP 3134Philips Int'L B.V. · 1985
  • K851535Philips UV-a Solarium Type HP 3140Philips Int'L B.V. · 1985
  • K851536Philips UV-a Solarium Type HP 3141Philips Int'L B.V. · 1985
  • K851533Philips UV-a Sdarium Type HP 3148(CFR 21 SunlampPhilips Int'L B.V. · 1985
  • K851534Philips UV-a Solarium Type HP 3150Philips Int'L B.V. · 1985
  • K850206Philips UV-a Solarium Type HP 3126-SunlampPhilips Int'L B.V. · 1985

All 11 as Philips Int'L B.V. →