SeaSpine Meridian System

FDA registration

SEASPINE ORTHOPEDICS CORPORATION·2 products·🇺🇸 United States

SeaSpine Meridian System, SeaSpine Regatta Lateral System

FDA 510(k)

FDA Class 2 ·Orthopedic

ClearPoint System and Accessories

FDA registration

ClearPoint Neuro Inc.·1 product·🇺🇸 United States

ANTINUCLEAR ANTIBODY (ANA) Screen 9 ELISA

FDA registration

MONOCENT INC.·1 product·🇺🇸 United States

SMARTFrame Accessory Kit (7F)

FDA registration

Sterigenics US LLC·1 product·🇺🇸 United States

THE APTUS (AUTOMATED) APPLICATION OF THE TG IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE

FDA 510(k)

FDA Class 2 ·Immunology

IVS CLIP CLOSURE SYSTEM, MODEL 1002 (IVS CLIP APPLIER); IVS INTRUDUCER SET, MODEL 1001

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

EsophyX Z+ Device

FDA registration

Merit Medical Nederland BV·1 product·🇳🇱 Netherlands

EsophyX Z+ Device

FDA registration

Merit Medical Australia Pty Ltd.·1 product·🇦🇺 Australia

EsophyX Z+ Device

FDA registration

MERIT MEDICAL SYSTEMS, INC.·1 product·🇺🇸 United States

Praxis9151 (LN) - CytoCore

FDA registration

Isomedix Operations, Inc.·1 product·🇺🇸 United States

EsophyX Z+ Device

FDA registration

Terumo BCT STERILIZATION SERVICES, Inc.·1 product·🇺🇸 United States

APAS Independence with MRSA Analysis Module

FDA registration

LBT INNOVATIONS LIMITED·1 product·🇦🇺 Australia

EsophyX Z+ Device

FDA registration

Sterigenics U.S., LLC·1 product·🇺🇸 United States

Intervertebral Fusion Device With Bone Graft, Lumbar

FDA classification

FDA Class 2 ·Intervertebral Fusion Device With Bone Graft, Lumbar

Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls

FDA classification

FDA Class 2 ·Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls

Clip, Implantable

FDA classification

FDA Class 2 ·Clip, Implantable