EML105 ELECTROLYTE METABOLITE ANALYZER

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

BURTON APPLANATION TONOMETER - MODEL T850 & T1000

FDA 510(k)

FDA Class 2 ·Ophthalmic

SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900, S40 Sterilant Concentrate

FDA 510(k)

FDA Class 2 ·General Hospital

GUIDESHOT OPTION FOR CXR4 AND ECLOS CT SYSTEMS

FDA 510(k)

FDA Class 2 ·Radiology

GALLEON PEDICLE SCREW SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

ADVANCED THERAPY DOSIMETER

FDA 510(k)

FDA Class 2 ·Radiology

Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint, Susceptibility System with Lefamulin in the dilution range of 0.008-16ug/mL

FDA 510(k)

FDA Class 2 ·Microbiology

OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR COCAINE AND COCAINE METABOLITES

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ACQPLAN 5.0

FDA 510(k)

FDA Class 2 ·Radiology

ULTRASONIC BIOMETER/ PACHYMETER FOR OPHTHALMOLOGY, MODEL ODM 2100, 2200

FDA 510(k)

FDA Class 2 ·Radiology

MR PERMEABILITY

FDA 510(k)

FDA Class 2 ·Radiology

Vesco Medical Extension Feeding Set

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ATRICURE CRYO MODULE SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

EXTENSION SETS

FDA 510(k)

FDA Class 2 ·General Hospital

MX MOBILE X-RAY SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

INSCOPE MULTI-CLIP APPLIER, MODELS IN22321, IN23321

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

VIEWPOINT ENT/ORTHOPEDIC OPTION

FDA 510(k)

FDA Class 2 ·Neurology

Amsco Evolution Medium Steam Sterilizer

FDA 510(k)

FDA Class 2 ·General Hospital

RADIACARE INTRAOPERATIVE RADIOTHERAPY SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

VERIFY SELF-CONTAINED BIOLOGICAL INDICATOR FOR VAPORIZED (VH2O2) STERILIZATION PROCESSES

FDA 510(k)

FDA Class 2 ·General Hospital