CAHP HIGH PERFORMANCE CELLULOSE DIACETATE (CAPILLARY, HOLLOW FIBER)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CAHP HIGH PERFORMANCE CELLULOSE DIACETATE (CAPILLARY, HOLLOW FIBER)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ALTRA FLUX 200 HEMODIALYZER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PSN HEMODIALYZER, MODEL PSN 130, 150, 170, 210

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

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

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

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

GAMBRO POLYFLUX 17R, CAPILLARY DIALYZER/ FILTER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ASAHI AM-R SERIES DIALYZERS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

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

FRESENIUS POLYSULFONE HEMODIALYZERS, BOTH LOW AND HIGH FLUX

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CA CELLULOSE ACETATE HOLLOW FIBER DIALYZER (CA-90)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ASAHI AM-BIO SERIES DIALYZERS (WET MODELS)& (DRY MODELS), MODELS AM-BIO-50,AM-BIO-65, AM-BIO-75, AND AM-BIO-100, AM-BIO-

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Left, VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Right, VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Left, VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Right, VERASENSE for Zimmer Biomet Persona CR G-H/7-12 Left

FDA 510(k)

FDA Class 2 ·Neurology

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·SUNSOFT(METHAFILCON A)SOFT(HYDROPHILIC)CONTACT LEN

System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex

FDA Pre-Market Approval

FDA Class 2 ·AMPLICOR MYCOBACTERIUM TUBERCULOSIS (MTB) TEST

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ORAQUICK HCV RAPID ANTIBODY TEST

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·PTCA CATHETERS

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval

FDA Class 2 ·Dimension TPSA Flex reagent cartridge