510(k) Report

FDA applicant

Biomedical Ent., Inc.

San Antonio, TX13 decisions1996–20140 recalls

FDA records 13 decisions for Biomedical Ent., Inc. (San Antonio, TX) from 1996 to 2014: 13 510(k) clearances. Most are in product codes JDR (Staple, Fixation, Bone) and GEY (Motor, Surgical Instrument, Ac-Powered). Its devices cite 11 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, orthopedic panel, where it files most

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

FDA decisions per year

2in 2014

2010: 22013: 12014: 2
2007high 2 (2010) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

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

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Which product codes does it file in?

  • JDRStaple, Fixation, Bone6decisions
  • GEYMotor, Surgical Instrument, Ac-Powered3decisions
  • HTYPin, Fixation, Smooth2decisions
  • HBWFastener, Plate, Cranioplasty1decision
  • JEYPlate, Bone1decision

Whose devices does it build on?

Its devices cite 11 predicates; 5 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 41 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.

  • K993714Memograph Staple, Warm SystemBiomedical Ent., Inc. · 200018cite it
  • K001354Memograph; Osstaple - Orthopedic Uses for Small Bone and Fragment Fixation for the Memograph Staple SystemBiomedical Ent., Inc. · 20017cite it
  • K001353Memograph; Osstaple - Neurosurgical Uses for Craniofacial Fractures and Cranioplasty for the Memograph…Biomedical Ent., Inc. · 20013cite it
  • K001219Memograph; Osstaple - Oral and Maxilliofacial Procedures for the Memograph Staple SystemBiomedical Ent., Inc. · 20003cite it
  • K102107Osstaple ChillBiomedical Ent., Inc. · 20103cite it
  • K091951HammerlockBiomedical Ent., Inc. · 20102cite it

What has FDA decided for it lately?

  • K133844Speed TriadBiomedical Ent., Inc. · 2014
  • K133780Speed XLBiomedical Ent., Inc. · 2014
  • K131640Smooth or Threaded Metallic Bone FastenerBiomedical Ent., Inc. · 2013
  • K102107Osstaple ChillBiomedical Ent., Inc. · 2010
  • K091951HammerlockBiomedical Ent., Inc. · 2010
  • K023203OsstapleBiomedical Ent., Inc. · 2002
  • K001353Memograph; Osstaple - Neurosurgical Uses for Craniofacial Fractures and Cranioplasty for the Memograph…Biomedical Ent., Inc. · 2001
  • K001354Memograph; Osstaple - Orthopedic Uses for Small Bone and Fragment Fixation for the Memograph Staple SystemBiomedical Ent., Inc. · 2001

All 13 as Biomedical Ent., Inc. →