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. Author manuscript; available in PMC: 2015 Jun 15.
Published in final edited form as: Nanomedicine. 2012 Jun 6;9(1):1–14. doi: 10.1016/j.nano.2012.05.013

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