Catheter, Coronary, Atherectomy

FDA Pre-Market Approval

FDA Class 3 ·ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Pre-Market Approval

FDA Class 3 ·BLAZER PRIME XP AND BLAZER II XP CARDIAC ABLATION CATHETERS

Lipoprotein, Low Density, Removal

FDA Pre-Market Approval

FDA Class 3 ·LIPOSORBER LA-15 SYSTEM

Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring

FDA Pre-Market Approval

FDA Class 3 ·ANGIOSCULPT SCORING BALLOON CATHETER

Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring

FDA Pre-Market Approval

FDA Class 3 ·ANGIOSCULPT PTCA SCORING BALLOON CATHETER

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·ON-X PROSTHETIC HEART VALVE AND ON-X ASCENDING AORTIC PROSTHESIS (ONXAAP)

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·STOCKERT 70 RADIOFREQUENCY ABLATION GENERATOR

HOO2D SEAT-INFANT

FDA 510(k)

FDA Class 1 ·Anesthesiology

MEDI-COMP NEONATAL OXYGEN HOOD

FDA 510(k)

FDA Class 1 ·Anesthesiology

FENESTRA HOOK

FDA 510(k)

FDA Class 2 ·Radiology

DIRD INGANT O2 (BIO 2 HOOD)

FDA 510(k)

FDA Class 1 ·Anesthesiology

AEROSOL DELIVERY HOOD

FDA 510(k)

FDA Class 1 ·Anesthesiology

SPAG PAK

FDA 510(k)

FDA Class 1 ·Anesthesiology

SEA-LONG NECKSEAL & HOOD

FDA 510(k)

FDA Class 1 ·Anesthesiology

KEYSTONE OXYGEN TENT

FDA 510(k)

FDA Class 1 ·Anesthesiology

NOVA OXYGEN TENT

FDA 510(k)

FDA Class 1 ·Anesthesiology

MEDIUM SIZE OXYGEN HOOD #1547

FDA 510(k)

FDA Class 1 ·Anesthesiology

NASCOR IGLOO

FDA 510(k)

FDA Class 1 ·Anesthesiology

NASCOR OXYDOME

FDA 510(k)

FDA Class 1 ·Anesthesiology

VITROS Chemistry Products Calibrator Kit 25

FDA registration

Ortho Clinical Diagnostics·3 products·🇸🇬 Singapore