OptoWire Deux

FDA 510(k)

FDA Class 2 ·Cardiovascular

Fine Osteotomy™

FDA 510(k)

FDA Class 2 ·Orthopedic

BC Reflex Uni Knee System

FDA 510(k)

FDA Class 2 ·Orthopedic

Panthera Dental Milled Bars

FDA 510(k)

FDA Class 2 ·Dental

Panthera Dental Milled Bars

FDA 510(k)

FDA Class 2 ·Dental

BC Reflex Uni Knee System

FDA 510(k)

FDA Class 2 ·Orthopedic

HABIB LAPAROSCOPIC HEXABLATE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

COBAS C TINA-QUANT CYSTATIN C GEN.2 ASSAY, C.F.A.S. CYSTATIN C CALIBRATOR, CYSTATIN C GEN.2 CONTROL SET

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

TINA-QUANT HEMOGLOBIN A1C GEN.2 TEST SYSTEM

FDA 510(k)

FDA Class 2 ·Hematology

DIOMED 25 SURGICAL DIODE LASER, GEN SURG APPLICAT

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CONTOUR® NEXT GEN Blood Glucose Monitoring System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

COBAS C ACETAMINOPHEN GEN.2 ASSAY, ACET2 CALIBRATOR

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Contour® next GEN Blood Glucose Monitoring System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ISE INDIRECT NA, K, CL FOR GEN.2

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

PHOENIX STERI-TECH STERILE DENTAL PACK GEN-10001

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

AFFIX(R) NEXT GEN SPINOUS PROCESS PLATE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

FIELD MEDICAL OXYGEN GEN/DIST SYS-BATTLEFIELD PURP

FDA 510(k)

FDA Class 2 ·Anesthesiology

SURGILASE YAG 100 SURGICAL ND:YAG LASER/GEN SURG

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Aulisa Infant Oximeter Module (2nd Gen.) (GA-OM0018)

FDA 510(k)

FDA Class 2 ·Cardiovascular

ISE INDIRECT NA, K, C1 FOR GEN 2

FDA 510(k)

FDA Class 2 ·Clinical Chemistry