Biocompatibles, Inc. is one of 20445 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Biocompatibles, Inc. - FDA 510(k) Cleared Devices
Recent clearances: RADIOACTIVE SEED LOCALIZATION NEEDLE, SYNTHETIC SEEDING SPACER MODEL SS9 X 50-50, SS9 X 55-50, SS9 X 55-150, SS9 X 1CM-30, WORLDWIDE MEDICAL TECHNOLOGIES ANCHOR MARKER, MARKER STRAND AND MARKER
3
Total
3
Cleared
0
Denied
Biocompatibles, Inc. is a medical device manufacturer with a manufacturing facility in Oxford, US. The company specializes in Radiology devices for clinical imaging and interventional procedures.
Biocompatibles has received 3 FDA 510(k) clearances from 3 total submissions. The company's regulatory activity spans from 2009 to 2011, with all submissions focused on Radiology devices. The company is currently inactive, with no clearances issued in more than a decade.
Historical cleared devices include radioactive seed localization needles, synthetic seeding spacers, and anchor markers used in radiological guidance and tumor localization procedures. These products reflect the company's focus on precision imaging tools for interventional radiology applications.
Explore the complete regulatory history, device names, product codes, and clearance dates in the database records below.
FDA 510(k) Regulatory Record - Biocompatibles, Inc.
3 devices