AXIOS Stent and Electrocautery-Enhanced Delivery System (6mmx8mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (8mmx8mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (10mmx10mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (15mmx10mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (20mmx10mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (15mmx15mm)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

RB12 SUCTION RECTAL BIOPSY SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CUDDLE HEART -AUDITORY/VIBRATION DEVICE

FDA 510(k)

FDA Class 2 ·General Hospital

KINAMED ATH-POROUS AND ATH-POROUS LONG TOTAL HIP

FDA 510(k)

FDA Class 2 ·Orthopedic

CARDIOSTREAM SONOAIM

FDA 510(k)

FDA Class 2 ·Radiology

Z-BLOCK, MODELS 20/19, 40/19, 55/19

FDA 510(k)

FDA Class 2 ·Dental

DOCTOR'S LIGHT LED DENTAL CURING LIGHT

FDA 510(k)

FDA Class 2 ·Dental

CRIB CUDDLE - INFANT BED

FDA 510(k)

FDA Class 2 ·General Hospital

SAVVY LONG AND SLEEK PERIPHERAL TRANSLUMINAL ANGIOPLASTY (PTA) CATHETERS

FDA 510(k)

FDA Class 2 ·Cardiovascular

System, Test, Carcinoembryonic Antigen

FDA Pre-Market Approval

FDA Class 2 ·TANDEM(R) E CEA IMMUNORADIOMETRIC ASSAY

VIANOX DELIVERY SYSTEM, MODEL II

FDA 510(k)

FDA Class 2 ·Anesthesiology

VIANOX DELIVERY SYSTEM, MODEL I

FDA 510(k)

FDA Class 2 ·Anesthesiology

CT42 CARDIAC COMPUTED TOMOGRAPHY (CT) SOFTWARE

FDA 510(k)

FDA Class 2 ·Radiology

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

MEDISIZE GOLD

FDA 510(k)

FDA Class 2 ·Anesthesiology

MEDISIZE BLUE, MEDISIZE GREEN, MEDISIZE RED

FDA 510(k)

FDA Class 2 ·Anesthesiology

MEDISIZE GOLD HEATER AND BOOSTER

FDA 510(k)

FDA Class 2 ·Anesthesiology

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval

FDA Class 2 ·Cobas CMV

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval

FDA Class 2 ·cobas CMV

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval

FDA Class 2 ·Alinity m CMV Assay