ORTHO SPECTRUM III & ORTHO-MUNE OK

FDA 510(k)

FDA Class 2 ·Hematology

Kyphoplasty Balloon System

FDA 510(k)

FDA Class 2 ·Orthopedic

OPTIMUM GP OK Daily Wear Contact Lens (roflufocon D & E)

FDA 510(k)

FDA Class 2 ·Ophthalmic

Monitor, Airway Pressure (Includes Gauge And/Or Alarm)

FDA Pre-Market Approval

FDA Class 2 ·NON-ABSORBABLE BLACK SILK SUTURE

Suture, Nonabsorbable, Synthetic, Polyester

FDA Pre-Market Approval

FDA Class 2 ·POLYVIOLENE SUTURE

Suture, Nonabsorbable, Synthetic, Polyester

FDA Pre-Market Approval

FDA Class 2 ·POLYVIOLENE SUTURE

Suture, Nonabsorbable, Synthetic, Polyester

FDA Pre-Market Approval

FDA Class 2 ·POLYVIOLENE SUTURE

Monitor, Airway Pressure (Includes Gauge And/Or Alarm)

FDA Pre-Market Approval

FDA Class 2 ·NON-ABSORBABLE BLACK SILK SUTURE

Monitor, Airway Pressure (Includes Gauge And/Or Alarm)

FDA Pre-Market Approval

FDA Class 2 ·NON-ABSORBABLE BLACK SILK SUTURE

ORTHO-MUNE OK-COMBO CONTROL IGG2A-FITC/IGG2A-PE MONOCLONAL ANTIBODY (MURINE)

FDA 510(k)

FDA Class 2 ·Hematology

ORTHO-MUNE OK-COMBO CD40FITC/CD8-PE (OKT4A/OKT8) MONOCLONAL ANTIBODY (MURINE)

FDA 510(k)

FDA Class 2 ·Hematology

ORTHO-MUNE OK-COMBO CD3-FITC/CD4-PE (OKT2/OKT4A) MONOCLONAL ANTIBODY (MURINE)

FDA 510(k)

FDA Class 2 ·Hematology

ORTHO-MUNE OK-COMBO CD3-FITC/CD19-PE (OKT3/OKB19A MONOLCLONAL ANTIBODY (MURINE)

FDA 510(k)

FDA Class 2 ·Hematology

AIRPERM (SIFLUFOCON A) RIGID GAS PERMEABLE OK CONTACT LENSES FOR DAILY WEAR ORTHOKERATOLOGY

FDA 510(k)

FDA Class 2 ·Ophthalmic

ORTHO-MUNE OK-COMVO CD3-FITC/CD8-PE (OKT 3/OKT8) MONOCLONAL ANTIBODY (MURINE)

FDA 510(k)

FDA Class 2 ·Hematology

RICH-MAR MODEL 510 ULTRASOUND

FDA 510(k)

FDA Class 2 ·Physical Medicine

SABER TECH IMPLANTS SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

CARAPACE STERILE GAUZE TRAYS

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

FAST FORMALERT

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PREDICTOR

FDA 510(k)

FDA Class 2 ·Cardiovascular