Biocompatibles, Inc.
Country not established
- Devices
- 6
What Biocompatibles, Inc. makes
Biocompatibles, Inc. manufactures medical devices including radioactive seed localization needles for precise brachytherapy planning, anchor markers and marker strands for surgical localization, and floppy/intermediate guide wires coated with phosphorylcholine polymer for coronary interventions. The company also produces synthetic seeding spacers for brachytherapy procedures and a daily-wear contact lens designed for extended ocular comfort.
These devices are classified as Class II under FDA regulations and are supported by 510(k) clearances. The company is based in the United States and its products are listed in the FDA’s 510(k) registry.
Catalogue
Radioactive Seed Localization Needle Ref K111979
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Proclear Daily Wear Contact Lens Ref K952152
Regimes: 510(k) Registry: 510(k)0.014 Floppy & 0.014 Intermediate Guide Wires W/Phosphorylcholine Polymer Coating & 4cm Radiopaque Tip Ref K961232
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Biocompatibles, Inc. have in the registry?
The registry currently lists 6 devices for Biocompatibles, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Biocompatibles, Inc.'s devices?
Among its 6 most recently registered devices, Biocompatibles, Inc. has devices listed in FDA 510(k) (6 devices).
What risk classes do Biocompatibles, Inc.'s devices fall under?
Among its 6 most recently registered devices, the classes recorded for Biocompatibles, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Biocompatibles, Inc. in the registry?
The most recently registered devices listed for Biocompatibles, Inc. include RADIOACTIVE SEED LOCALIZATION NEEDLE, WORLDWIDE MEDICAL TECHNOLOGIES ANCHOR MARKER, MARKER STRAND AND MARKER, PROCLEAR DAILY WEAR CONTACT LENS and 0.014 FLOPPY & 0.014 INTERMEDIATE GUIDE WIRES W/PHOSPHORYLCHOLINE POLYMER COATING & 4CM RADIOPAQUE TIP.