DADE (PAI-1) CHROMOGENIC ASSAY DADE COAGTROL-PAI

FDA 510(k)

FDA Class 2 ·Hematology

SPECTROLYSE/PL PAI KIT

FDA 510(k)

FDA Class 2 ·Hematology

CHROMOLIZE PAI-1 KIT

FDA 510(k)

FDA Class 2 ·Hematology

TINTELIZE PAI-1 KIT

FDA 510(k)

FDA Class 2 ·Hematology

TREASURE BIPOLAR HEAD, FEMORAL HEAD, TREASURE BIPOLAR HEAD, INSERT

FDA 510(k)

FDA Class 2 ·Orthopedic

Edwards Algorithm for Measurement of Blood Hemoglobin

FDA 510(k)

FDA Class 2 ·Cardiovascular

Acumen Assisted Fluid Management (AFM) Software Feature

FDA 510(k)

FDA Class 2 ·Cardiovascular

MILESTONE REVISION KNEE SYSTEM (MRKS) - FEMORAL COMPONENT, TIBIAL BASEPLATE, TIBIAL INSERT, STEMS, FEMORAL & TIBIAL AUGM

FDA 510(k)

FDA Class 2 ·Orthopedic

ZENITH, FEMORAL STEM ZENITH, DISTAL CENTRALIZER FOMORAL HEAD ACETABULAR INSERT

FDA 510(k)

FDA Class 2 ·Orthopedic

SUCTION COAGULATOR

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SPECTROLYSE PAI-1, MODEL 101201

FDA 510(k)

FDA Class 2 ·Hematology

MODERN MEDICAL RESECTOSCOPE ELECTRODES

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MODERN MEDICAL BIPOLAR FORCEPS

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

COLOPLAST PERISTEEN ANAL IRRIGATION (PAI) SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

NTU-USB Ultrasound USB Box

FDA 510(k)

FDA Class 2 ·Radiology

Precision AI Surgical Planning System (PAI-SPS)

FDA 510(k)

FDA Class 2 ·Orthopedic

Precision AI Surgical Planning System (PAI-SPS)

FDA 510(k)

FDA Class 2 ·Orthopedic

IMUBIND PLASMA PAI-1 ELISA,MODEL 822

FDA 510(k)

FDA Class 2 ·Hematology

K-SHIELD ADVANTAGE PORT ACCESS INFUSION SET (PAIS)

FDA 510(k)

FDA Class 2 ·General Hospital

K-Shield Advantage Port Access Infusion Set (PAIS)

FDA 510(k)

FDA Class 2 ·General Hospital