OXOID STREPTOCOCAL GROUPING KIT

FDA 510(k)

FDA Class 1 ·Microbiology

LSF HA COATED TRIAD TOTAL HIP SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

TRUFREEZE SYSTEM, TRUFREEZE SPRAY KIT

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Xcite Clinical Station

FDA 510(k)

FDA Class 2 ·Physical Medicine

OHMEDA - OHIO(R) CARE PLUS INCUBATOR

FDA 510(k)

FDA Class 2 ·General Hospital

Acuitas AMR Gene Panel

FDA 510(k)

FDA Class 2 ·Microbiology

LACTOPLATE

FDA 510(k)

FDA Class 1 ·Immunology

MENDEC SPINE HV, MENDEC SPINE HV SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

MODIFICATION TO HYBRID CAPTURE II CT/GC TEST, MODEL 03M90-01

FDA 510(k)

FDA Class 1 ·Microbiology

IODOSORB POWDER

FDA 510(k)

FDA Class 1 ·General, Plastic Surgery

OSCAR, MODEL OE3000

FDA 510(k)

FDA Class 2 ·Orthopedic

AMBU PORTABLE SUCTION UNIT

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MagXtract Collection Tube

FDA 510(k)

FDA Class 2 ·Microbiology

GENTAMICIN 120 UG, STREPTOMYCIN 30 UG SENSI-DISC SUSPECTIBILITY TESTS

FDA 510(k)

FDA Class 2 ·Microbiology

SARNS HIGH FLOW AORTIC ARCH CANNULA

FDA 510(k)

FDA Class 2 ·Cardiovascular

GORE BIO-A FISTULA PLUG

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

POLYMED THERAPEUTICS FASTEP DIPSTICK DRUGS OF ABUSE SCREEN DEVICE AND DIPCARD DRUGS OF ABUSE SCREEN DEVICE

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

BD VIPER SYSTEM

FDA 510(k)

FDA Class 2 ·Microbiology

RT300-S, MODEL FA100052; RT300-SP, MODEL FA100053

FDA 510(k)

FDA Class 2 ·Neurology

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM CEPHALOTHIN - GN 1 - 64 UG/ML

FDA 510(k)

FDA Class 2 ·Microbiology