EXTRAFIX EXTERNAL FIXATION SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

Curing Light, Model: MaxCure 9

FDA 510(k)

FDA Class 2 ·Dental

Ultrasonic Scaler Tips

FDA 510(k)

FDA Class 2 ·Dental

QUEX ED; QUEX S

FDA 510(k)

FDA Class 2 ·Neurology

AcQGuide Flex with AcQCross QX, AcQGuide Mini with AcQCross QX

FDA 510(k)

FDA Class 2 ·Cardiovascular

LOTUS ULTRASONIC SYSTEM FOR CEMENTED IMPLANT EXTRACTION (USCIX)

FDA 510(k)

FDA Class 2 ·Orthopedic

CONTAFLEX 54 (hioxifilcon D) Spherical Soft Contact Lens for Daily Wear, CONTAFLEX 49 (hioxifilcon B) Spherical Soft Contact Lens for Daily Wear,

FDA 510(k)

FDA Class 2 ·Ophthalmic

MIRADA XD

FDA 510(k)

FDA Class 2 ·Radiology

MIRADA RT

FDA 510(k)

FDA Class 2 ·Radiology

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·IDEL 67 CONTACT LENS

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·IGEL 67 CONTACT LENS

AcQCross Qx Integrated Transseptal Dilator/Needle

FDA 510(k)

FDA Class 2 ·Cardiovascular

AcQCross Qx Integrated Transseptal Dilator/Needle

FDA 510(k)

FDA Class 2 ·Cardiovascular

HISPEED QX/I CT SCANNER SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

FOTONA QX ND:YAG/KTP LASER SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

FOTONA QX ND:YAG/KTP LASER SYSTEM FAMILY

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

KONICA QX-70 AUTOMATIC X-RAY FILM PROCESSOR

FDA 510(k)

FDA Class 2 ·Radiology

KONICA QX-130APLUS AUTOMATIC X-RAY FILM PROCESSOR

FDA 510(k)

FDA Class 2 ·Radiology

BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAY

FDA 510(k)

FDA Class 2 ·Microbiology

BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAY

FDA 510(k)

FDA Class 2 ·Microbiology