Table 6.
Confirmed and likely nanomedicine products identified, that have been approved by the FDA through the 510k process.
| Use | Application(s)/Product(s) | Company | Approval Year | Nanocomponent Description |
|---|---|---|---|---|
| Bone Substitute | Vitoss [14] | Orthovita | 2003 | 100 nm Calcium-Phosphate Nanocrystals |
| Ostim [68] | Osartis | 2004 | 20 nm Hydroxapatite Nanocrystals | |
| OsSatura [69] | Isotis Orthobiologics US | 2003 | Hydroxapatite Nanocrystals | |
| NanOss [57] | Angstrom Medica, Inc. | 2005 | Hydroxapatite Nanocrystals | |
| Alpha-bsm, Beta-bsm, Gamma-bsm, EquivaBone, CarriGen [95] | ETEX Corporation | 2009 | Hydroxapatite Nanocrystals | |
| Dental Composite | Ceram × Duo [96] | Dentspley | 2005 | Ceramic Nanoparticles |
| Filtek [97] | 3M Company | 2008 | Silica and Zirconium Nanoparticles | |
| Premise [14] | Sybron Dental Specialties | 2003 | "Nanoparticles" | |
| Nano-Bond [98] | Pentron® Clinical Technologies, LLC | 2007 | "Nanoparticles" | |
| Device Coating | ON-Q SilverSoaker / SilvaGard™ [99] | I-Flow Corporation / AcryMed, Inc. | 2005 | Anti-Microbial Nanosilver |
| EnSeal Laparoscopic Vessel Fusion [39] | Ethicon Endo-Surgery, Inc. | 2005 | Nanoparticle Coated Electrode | |
| NanoTite Implant [100] | Biomet | 2008 | Calcium Phosphate Nanocrystal Coating | |
| In Vitro Assay | CellTracks® [14] | Immunicon Corporation | 2003 | Magnetic Nanoparticles |
| NicAlert [14] | Nymox | 2002 | Colloidal Gold | |
| Stratus CS [69] | Dade Behring | 2003 | Dendrimers | |
| CellSearch® Epithelial Cell Kit [101] | Veridex, LLC (Johnson & Johnson) | 2004 | Iron-Oxide Nanoparticles | |
| Verigene [102,103] | Nanosphere, Inc. | 2007 | Colloidal Gold | |
| MyCare™ Assays [104] | Saladax Biomedical | 2008 | "Nanoparticles" | |
| Medical Dressing | Acticoat® [99,105] | Smith & Nephew, Inc. | 2005 | Anit-Microbial Nanosilver |
| Dialysis Filter | Fresenius Polysulfone® Helixone® [106] | NephroCare | 1998 | Nanoporous Membrane |
| Tissue Scaffold | TiMESH [39] | GfE Medizintechnik GmbH | 2004 | 30 nm Titanium Coating |