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QUICK & SURE ONESTEP HOME PREGNANCY TEST

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

AIA-PACK IGE II ASSAY

FDA 510(k)
FDA Class 2 ·Immunology

da Vinci SP Surgical System (SP1098)

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

INRATIO 2 PT MONITORING SYSTEM

FDA 510(k)
FDA Class 2 ·Hematology

HardyDisk AST Cefiderocol 30µg (FDC30)

FDA 510(k)
FDA Class 2 ·Microbiology

HYCOR HY.TEC/MANUAL RF AUTO-ANTIBODY

FDA 510(k)
FDA Class 2 ·Immunology

GRASEBY PCAS MODEL NO. 0124-0701, PVS DYTINHR PUMP

FDA 510(k)
FDA Class 2 ·General Hospital

UNIT, PHACOFRAGMENTATION

FDA 510(k)
FDA Class 2 ·Ophthalmic

YUE/FA DISPOSABLE SYRINGE

FDA 510(k)
FDA Class 2 ·General Hospital

TRACKER UNIBODY, UNIBODY W/SIDE & 25 SIDE HOLES

FDA 510(k)
FDA Class 2 ·Cardiovascular

AVEA VENTILATOR

FDA 510(k)
FDA Class 2 ·Anesthesiology

VBL SERUM TROPONIN I TEST, MODEL 1001

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

NEW STAR LASERS, INC. DOVE ND: YAG LASER SYSTEM, MODEL: NS-160

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

STRYKER MINI-MENDER MENISCAL REPAIR SYSTEM

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

CARDIOTOMY/VENOUS RESERVOIR NO.: CVR SERIES

FDA 510(k)
FDA Class 2 ·Cardiovascular

MAXIMA* HOLLOW FIBER OXYGENATOR W/FILTERED RESERV.

FDA 510(k)
FDA Class 2 ·Cardiovascular

Penumbra Embolectomy Aspiration System (INDIGOTM Aspiration System)

FDA 510(k)
FDA Class 2 ·Cardiovascular

REFINITY Rotational IVUS Catheter, REFINITY Rotational IVUS Catheter, Short Tip

FDA 510(k)
FDA Class 2 ·Cardiovascular

SONOACE 600 DIAGNOSTIC ULTRASOUND SYSTEM

FDA 510(k)
FDA Class 2 ·Radiology

FLEXIBLE FIBER OPTIC LAPAROSCOPES

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology