Lens, Contact, Orthokeratology, Overnight

FDA Pre-Market Approval

FDA Class 3 ·Euclid Systems Orthokeratology (tisilfocon A) Contact Lenses for Overnight Wear

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·Lotrafilcon A and B Soft Contact Lenses for Extended Wear

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·Biofinity (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear

Material, Dressing, Surgical, Polylactic Acid

FDA Pre-Market Approval

FDA Class 3 ·HELITAPE AND HELIPLUG ABSORBABLE COLLAGEN WOUND DRESSING FOR DENTAL SURGERY

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·AID (R) B/BR HIGH VOLTAGE CABLES FOR ECD SYSTEMS

Material, Dressing, Surgical, Polylactic Acid

FDA Pre-Market Approval

FDA Class 3 ·COLLACOTE, COLLATAPE, COLLAPLUG ABSORABLE COLLAGEN WOUND DRESSINGS FOR DENTAL SURGERY

Material, Dressing, Surgical, Polylactic Acid

FDA Pre-Market Approval

FDA Class 3 ·COLLACOTE,COLLATAPE,COLLAPLUG ABSORBABLE COLLAGEN WOUND DRESSINGS FOR DENTAL SURGERY

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·Biofinity (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·Biofinity (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear

Material, Dressing, Surgical, Polylactic Acid

FDA Pre-Market Approval

FDA Class 3 ·CollaCote, CollaTape, CollaPlug, Absorbable Collagen Wound Dressing for Dental Surgery

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·Biofinity (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear

Material, Dressing, Surgical, Polylactic Acid

FDA Pre-Market Approval

FDA Class 3 ·COLLACOLE, COLLATAPE, COLLAPLUG ABSORBABLE COLLAGEN WOUND DRESSING FOR DENTAL SURGERY

Material, Dressing, Surgical, Polylactic Acid

FDA Pre-Market Approval

FDA Class 3 ·CollaCote, CollaTape, CollaPlug, Absorbable Collagen Wound Dressings for Dental Surgery

Material, Dressing, Surgical, Polylactic Acid

FDA Pre-Market Approval

FDA Class 3 ·COLLACOTE, COLLATAPE, COLLAPLUG ABSORBABLE COLLAGEN WOUND DRESSINGS FOR DENTAL SURGERY

Material, Dressing, Surgical, Polylactic Acid

FDA Pre-Market Approval

FDA Class 3 ·CollaCote, CollaTape, CollaPlug Absorbable Collagen Wound Dressings for Dental Surgery

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·Lotrafilcon B soft Contact Lenses for daily and extended wear

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval

FDA Class 3 ·cobas HPV for use on the cobas 6800/8800 Systems

Enzyme Immunoassay, Fetal Fibronectin

FDA Pre-Market Approval

FDA Class 3 ·Rapid fFN for the TLiIQ System, Fetal Fibronectin Enzyme Immunoassay

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval

FDA Class 3 ·cobas HPV for use on the cobas 6800/8800 Systems

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval

FDA Class 3 ·COBAS TaqMan HBV Test, For Use With High Pure System