DIMENSION CKI FLEX REAGENT CARTRIDGE, DIMENSION MBI FLEX REAGENT CARTRIDGE, AND CKI/MBI CALIBRATOR, MODELS DF38, DF32

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Donagamex Blue Performance Protective Gown

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ReVene Thrombectomy Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

GLUCOCARD® W onyx Blood Glucose Monitoring System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

AUTION ELEVEN Semi-Automated Urinalysis System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

AUTION MAX AX-4060 Urinalysis System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

AUTION EYE AI-4510 Urine Particle Analysis System

FDA 510(k)

FDA Class 2 ·Hematology

AKI COMPACS DATA COMPRESION MODULE FOR DIAGNOSTIC IMAGES

FDA 510(k)

FDA Class 2 ·Radiology

FOCUS TOUCH CONCEPTION SYSTEM

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

SALUMEDICA NERVE CUFF

FDA 510(k)

FDA Class 2 ·Neurology

Multi-Lancet Device 2, ReliOn Premier Lancing Device

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CAPD COLOR-GUARD SYSTEM PREPKIT

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

TENCKHOFF PERITONEAL TUBING ADAPT.

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PARALLEL PLATE DIALYZER HOLDER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

TUBING CONNECTOR #10-810-60 100/PKG NON-STERILE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

AMER. BENTLEY HEMOFILTER HOLDER HFH-1

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PUMP SEGMENT RINSE LINE W/ SLIP-ON CONNECTOR, PUMP SEGMENT RINSE LINE W/ LUER-LOCK CONNECTOR, T-CONNECTOR, SHORT, W/ SLI

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

HOLLOW FIBER DIALYZER HOLDER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Disposable Surgical Face Mask

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

VinDr-Mammo

FDA 510(k)

FDA Class 2 ·Radiology