ALTRA FLUX 200 HEMODIALYZER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MOUTH-TO-MOUTH SHIELD APPLICATOR

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

GAMBRO POLYFLUX 6 LR, 8 LR AND 10 LR

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CA CELLULOSE ACETATE HOLLOW FIBER DIALYZER (CA-170/CA-210)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

RAPID TOX CUP

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

CT CELLULOSER TRIACETATE HOLLOW FIBER DIALYZER (CT-110G/CT-190G)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ACCUSIGN DOA 10,ACCUSIGN DOA PANEL,ACCUSIGN MET/OPI/COC/THC/PCP/BZO/BAR/MTD/TCA/AMP,BIOSIGN DOA 10, BIOSIGN MET/OPI/COC/

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

BENZODIAZEPINES BY REMEDI HS

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

GAMBRO POLYFLUX 17R, CAPILLARY DIALYZER/ FILTER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MODIFICATION TO: ACCUSIGN RC DOA 10 (MET/OPI/COC/THC/PCP/BZO/BAR/MTD/TCA/AMP

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ACCUSIGN DOA 10, ACCUSIGN DOA 10 PANEL, ACUSIGN MET/OPI/COC/THC/PCP/BZO/BAR/MTD/TCA/AMP, BIOSIGN DOA10, BIOSIGN MET/OPI/

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ALTRA NOVA 200 HEMODIALYZER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PRIMUS HOLLOW FIBER DIALYZER (MODELS 1000,1000S,1350,1350S,2000,2000S)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

VYGON GUEDEL AIRWAY 511 VYGON BERMANN/OROPHAR AIRW

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Ion PGM Dx System

FDA 510(k)

FDA Class 2 ·Immunology

ILLUMINA MISEQDX PLATFORM

FDA 510(k)

FDA Class 2 ·Immunology

Fractional CO2 Laser Machine

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Pulse Oximeter (Model Number-SO611), Pulse Oximeter (Model Number- S0711), Pulse Oximeter (S0811), Pulse Oximeter (S0911)

FDA 510(k)

FDA Class 2 ·Cardiovascular

Medical Picosecond ND: YAG Laser System (PZ-6)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Vsmilehappyzir Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank

FDA 510(k)

FDA Class 2 ·Dental