RIANEN ASSAY SYSTEM, 125I KIT

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

AMEBIASIS ELISA TEST KIT

FDA 510(k)

FDA Class 2 ·Microbiology

COAT-A-COUNT DIGOXIN RIA

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Enlight 1810

FDA 510(k)

FDA Class 2 ·Anesthesiology

Anterior Cervical Plate System

FDA 510(k)

FDA Class 2 ·Orthopedic

TOSCA PCO2, SPO2 AND PULSE RATE MONITORING SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

BAUMER PLATES

FDA 510(k)

FDA Class 2 ·Orthopedic

BAUMER PINS

FDA 510(k)

FDA Class 2 ·Orthopedic

BAUMER STAPLES

FDA 510(k)

FDA Class 2 ·Orthopedic

INTRAMEDULLARY SYSTEMS

FDA 510(k)

FDA Class 2 ·Orthopedic

BAUMER SCREWS

FDA 510(k)

FDA Class 2 ·Orthopedic

Broncho Videoscope System (Single-use Broncho Videoscope (SBV-1A-B, SBV-1A-P, SBV-1B-B, SBV-1B-P, SBV-1C-B, SBV-1C-P); Full HD Visualization Endoscopic Image Processor (HDVS-S300A, HDVS-S300B, HDVS-S300C, HDVS-S300D); Endoscopic Image Processor (HDVS-S100A, HDVS-S100D))

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Urology Videoscope System (Single-use Flexible Ureteroscope: SUV-1A-B, SUV-1A-P, SUV-2A-B, SUV-2A-P, SUV-2B-B, SUB-2B-P, SUV-2C-B, SUV-2C-P;Single-use Flexible Cystoscope: SUV-1D-B, SUV-1D-P; Endoscopic Image Processor: HDVS-S100A, HDVS-S100D.)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Needle, Conduction, Anesthetic (W/Wo Introducer)

FDA classification

FDA Class 2 ·Needle, Conduction, Anesthetic (W/Wo Introducer)

Valve, Non-Rebreathing

FDA classification

FDA Class 2 ·Valve, Non-Rebreathing

Coccidioides Spp. Nucleic Acid Detection System For Respiratory Specimens

FDA classification

FDA Class 2 ·Coccidioides Spp. Nucleic Acid Detection System For Respiratory Specimens

MERIFLUOR(TM)-GIARDIA

FDA 510(k)

FDA Class 2 ·Microbiology

HEMOCLIP X-20 AUTOMATIC HEMOCLIP LIGATING APPLIER

FDA 510(k)

FDA Class 2 ·Microbiology

Kit, Immunochromatographic, Bacillus Anthracis Differential Antibody

FDA classification

FDA Class 2 ·Kit, Immunochromatographic, Bacillus Anthracis Differential Antibody

ID-FISH Plasmodium Genus Test Kit, ID-FISH Plasmodium falciparum and P. vivax Combo Test Kit

FDA 510(k)

FDA Class 2 ·Microbiology