Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·Edwards Certitude Delivery System, Edwards Certitude Introducer Sheath Set, Edwards Commander Delivery System, Edwards C

Mitral Valve Repair Devices

FDA Pre-Market Approval

FDA Class 3 ·PASCAL Precision Implant System, PASCAL Precision Guide Sheath

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval

FDA Class 3 ·Ranger Paclitaxel-Coated PTA Balloon Catheter

AW-100

FDA registration

MICRON CORP.·1 product·🇯🇵 Japan

YU-100

FDA registration

MICRON CORP.·1 product·🇯🇵 Japan

SA-100

FDA registration

MICRON CORP.·1 product·🇯🇵 Japan

VIP60

FDA registration

MICRON CORP.·1 product·🇯🇵 Japan

M-Tip

FDA registration

MICRON CORP.·1 product·🇯🇵 Japan

Quick Jet M

FDA registration

MICRON CORP.·1 product·🇯🇵 Japan

MICRON CORP.

FDA registration

MICRON CORP.·1 product·🇯🇵 Japan

Titan IV IEPlate

FDA registration

HELENA LABORATORIES, CORP.·1 product·🇺🇸 United States

TITAN GEL IFE Trivalent

FDA registration

HELENA LABORATORIES, CORP.·1 product·🇺🇸 United States

NITTOBO MEDICAL CO., LTD. MEDICAL DEVELOPMENT CENTER

FDA registration

NITTOBO MEDICAL CO., LTD. MEDICAL DEVELOPMENT CENTER·1 product·🇯🇵 Japan

V8 Immunodisplacement Kit

FDA registration

Helena Laboratories UK Ltd·1 product·🇬🇧 United Kingdom

HYDRASHIFT 2/4 isatuximab

FDA registration

SEBIA·1 product·🇫🇷 France

IgE Rapid Test Cassette

FDA registration

ACRO BIOTECH Inc.·1 product·🇺🇸 United States

HYDRAGEL CSF

FDA registration

SEBIA·1 product·🇫🇷 France

Hydragel CSF Isofocusing

FDA registration

SEBIA·1 product·🇫🇷 France

Dimension IGA Flex

FDA registration

SIEMENS HEALTHCARE DIAGNOSTICS INC.·1 product·🇺🇸 United States

SPIFE Ultra IFE-15

FDA registration

HELENA LABORATORIES, CORP.·1 product·🇺🇸 United States