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

COBAS INTEGRA GLUCOSE HK GEN. 3 TEST SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex

FDA Pre-Market Approval

FDA Class 2 ·AMPLIFIED MTD (MYCOBACTERIUM TUBERCULOSIS DIRECT) TEST

System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex

FDA Pre-Market Approval

FDA Class 2 ·AMPLIFIED MTD (MYCOBACTERIUM TUBERCULOSIS DIRECT) TEST

cobas pure integrated solutions, Glucose HK Gen.3, ISE indirect Na for Gen.2, ONLINE DAT Methadone II, Elecsys TSH

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

COBAS C TINA-QUANT LIPOPROTEIN (A) GEN 2 ASSAY MODEL 05852625190; PRECISET LP (A) GEN 2 CALIFRATOR SET MODEL 05852641160

FDA 510(k)

FDA Class 2 ·Immunology

COBAS C 501 TINA-QUANT HBA1CDX GEN.3 ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

MD CO2 SURGICAL LASER SYSTEM/GEN. SURGERY AND ORTH

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Aulisa Oximeter Module (2nd Gen.) (GA-OM0007, GA-OM0008)

FDA 510(k)

FDA Class 2 ·Cardiovascular

CIRCON ACMI GEN SURG INSTRU FOR MINI INVASIVE SURG

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

INFRAREDIX NIR IMAGING SYSTEM, GEN. 1.0, MODEL MC-5

FDA 510(k)

FDA Class 2 ·Cardiovascular

DAVOL ENDO-FLO SUCT/IRRI PROBE (FOR GEN SURGERY)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology