510(k) Report

FDA applicant

Implant Sciences Corp.

Wakefield, MA6 decisions1999–20070 recalls

FDA records 6 decisions for Implant Sciences Corp. (Wakefield, MA) from 1999 to 2007: 6 510(k) clearances. All are in product code KXK (Source, Brachytherapy, Radionuclide). Its devices cite 14 predicates, 3 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, radiology panel, where it files most

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

FDA decisions per year

1in 2007

2007: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Implant Sciences 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?

  • KXKSource, Brachytherapy, Radionuclide6decisions

Whose devices does it build on?

Its devices cite 14 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 8 times; 3 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.

  • K042864Implant Sciences Corp, Model HDR-4140Implant Sciences Corp. · 20053cite it
  • K994317I-Plant, Model 3500Implant Sciences Corp. · 20002cite it
  • K990193Iodine Brachytherapy Seeds, Model 3000Implant Sciences Corp. · 19992cite it
  • K023073Seed LinkImplant Sciences Corp. · 20031cites it

What has FDA decided for it lately?

  • K070468Implant Sciences Corp. Model HDR 4454Implant Sciences Corp. · 2007
  • K042864Implant Sciences Corp, Model HDR-4140Implant Sciences Corp. · 2005
  • K023073Seed LinkImplant Sciences Corp. · 2003
  • K023242I-Plant Model 3500 (125IODINE Brachytherapy Seeds)-SterileImplant Sciences Corp. · 2002
  • K994317I-Plant, Model 3500Implant Sciences Corp. · 2000
  • K990193Iodine Brachytherapy Seeds, Model 3000Implant Sciences Corp. · 1999

All 6 as Implant Sciences Corp. →

Other applicant names beginning “Implant”

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

Implant Innovations, Inc. 51Implant Center of the Palm Beaches 32Implant Innovations International, Inc. 18Implant Direct Sybron Manufacturing, LLC 17Implant Technology, Inc. 13Implant Support Systems, Inc. 10Implant Direct, LLC 10Implant Protesis Dental 2004, S.L. 6Implant Integration Systems, Inc. 4Implant Logistics, Inc. 3Implant Corp. of America 3Implant Solutions Pty Ltd (Aka Osteon Medical) 2